Description Additional Information Reviews (0) Reviews. There are no reviews yet, would you like to submit yours? Penumbra is recalling JET 7 Xtra Flex because the catheter may become susceptible to distal tip damage during use. 6 F (2.03 mm) long sheath.088 (2.24 mm) lumen allows for a wide range of device compatibility. select catheter. Overview. Penumbra Reperfusion Catheters and Separators and could result in damage to the JET 7 Reperfusion As part of the PENUMBRA SYSTEM, the Reperfusion . Phenom . Overview. Penumbra, Inc . Penumbra and FDA notified healthcare professionals of the Class 1 recall of the Neuron 5F Select Catheter, used to remove blood clots or foreign objects from blood vessels. 1: Add 4002C3260 Penumbra System Coil 400 COMPLEX STANDARD - 32mm x 60cm . The leaders of Penumbra, an extraordinarily successful Alameda, California - based manufacturer of neurovascular devices, have recently found themselves on the horns of this very dilemma. Individual Coils; Delivery Microcatheter; Detachment Handle . The Indigo System Lightning 12 was launched in July and is available immediately for patients needing interventional treatment for PE. Penumbra Select Catheters are designed to enable primary delivery of our access devices for placement into final position and to eliminate the need for an over-the-wire exchange. Write a review. PENUMBRA. Penumbra Reperfusion Catheter, 6 Fr Size, 139 cm Length /Each. Free! J. julrey New. enable primary delivery of our access devices for rapid, atraumatic placement into final position, eliminating the need for an . Ships Today! Free! ALAMEDA, Calif., Dec. 15, 2020 /PRNewswire/ -- Penumbra, Inc. (NYSE: PEN) today announced that it is voluntarily recalling all configurations of the Penumbra JET 7 Reperfusion Catheter with Xtra Flex technology (JET 7 Xtra Flex). Please email [email protected] or call us at 877-663-8686 and we will try to locate the product with our suppliers. BENCHMARK 071 5F Penumbra Select Catheter BENCHMARK 071 + 5F Penumbra Select Catheter Seamless transition zone with no shelf for atraumatic advancement. With one pass, . If a distal position is not initially established, this . Penumbra System Coil 400 COMPLEX STANDARD - 24mm x 57cm - Non-Expired: 24mm x 57cm $750.00. Add to cart. Benchmark 071 Catheter: 105cm, MP. ACE Reperfusion Catheter with Hi-Flow Aspiration Tubing, 6 Fr Size . Penumbra Neuron 5F Select Catheter, Neuro Deliver/Intracranial Access System Catheter, manufactured by Penumbra, Inc., Alameda, CA. Neuron 6F Select; Neuron 5F Select; DDC; Ruby Coil. . Please email [email protected] or call us at 877-663-8686 and we will try to locate the product with our . Cardiology . Qty Avail: 0. Neuron SIM-V 6F Select Catheter, 125 cm Working Length . Add to cart. Penumbra Select Catheters enable Rapid Primary Access into final position, eliminating the need for an over-the-wire exchange. Code Information: Catalog Number: PNS5f130H1; Lot Number: F15174. . Register for free to access our full content, including detailed information for each device. $100.00) Model #: PNS5F130BER OEM: Penumbra System Expiration Date: 2021 Size: 5Fr x .040" x 130cm . $100.00) Model #: PNS6F125BER OEM: Penumbra System Expiration Date: 2021 Size: 6Fr x 125cm x .040" UPC: Current Stock: This item is out of stock. The company announced the recall after the market closed Tuesday. neurovascular access catheter, used to track the penumbra select catheter and keep it stable while ascending into aortas. Free! . Add to Cart. $100.00) Model #: PNS5F120SIM OEM: Penumbra System Expiration Date: 2019 Size: 5Fr x 120cm x .040" UPC: Current Stock: This item is out of stock. Continuous manual aspiration was performed with maintaining the vacuum state between the tip of Penumbra . torque Select catheter towards the rst major turn. (NYSE: PEN), a global healthcare company focused on innovative therapies, today announced U.S. Food and Drug Administration 510(k) clearance for expanded indication of the Indigo Aspiration System. You must be . Neuron 6F Select; Neuron 5F Select; DDC; Ruby Coil. Neuron Select Catheter - BER - 5Fr x .040" x 130cm Penumbra System. DESCRIPTION SIZE INFO SPECIFICATIONS X-RAY MARKER COMPATIBILITY CORNER VIDEOS DOWNLOADS. . Sign in to add this product to your favorites! There was no negative influence on the procedure or the patient's well-being. The Penumbra CAT RX catheter was used in a total of 34 patients, with 71% STEMI, 23% NSTEMI, 3% UA, and 3% new onset heart failure. The recall follows a July warning letter from the company to healthcare providers. Select TM Catheter Construction All Penumbra Select Catheters Stainless braided shaft with radiopaque polymer steam-shaped tip Tapered profile of each Select catheter optimized for seamless transition and torque response Penumbra Select catheters do not have hydrophilic coating Neuron 5F Select | 120/130 cm.040" I.D. Enables primary access and atraumatic placement into desired vessel without an over-the-wire exchange; Useful for diagnostic angiogram - .040" lumen; Stainless steel braided proximal shaft for support and torque response with a soft polymer distal shaft to enable atraumatic vessel selection Unique Device Identifier (UDI) numbers provided by Penumbra are: 00815948020962, 00815948021594 and 00815948020955. Dive Brief: Penumbra recalled its Jet 7 Xtra Flex catheter device due to the risk of injuries and even death while removing clots in stroke patients, following advice from FDA. 2022 Penumbra, Inc. www.penumbrainc . Dive Brief: Penumbra recalled its Jet 7 Xtra Flex catheter device due to the risk of injuries and even death while removing clots in stroke patients, following advice from FDA. Offered pre-packaged with Penumbra 5F Select Catheter for rapid delivery to final position, eliminating an over-the-wire exchange. Early and efficient recanalization of large-vessel occlusion improves outcomes in select patient with acute ischemic stroke. Neuron MAX 088. When inserting a syringe to inject contrast medium the luer hub at the proximal end broke. 5F Select Catheter: 130cm, BER. Subsequently, the microcatheter and micro-guidewire were removed and a 20 ml syringe was connected to the proximal hub of the Penumbra catheter. 6F Select Catheter. Only a few steps and you are ready! Penumbra is recalling JET 7 Xtra Flex because the catheter may become susceptible to distal tip damage during use. Neuron Select Catheter-SIM-5Fr x 120cm x .040" Penumbra System. On (b) (6) 2020, the patient was undergoing a thrombectomy procedure in the m1 segment of the middle cerebral artery (mca) using a neuron max 6f 088 long sheath (neuron max), a neuron select catheter 6f, a penumbra system jetd reperfusion catheter (jetd) and a velocity . bioburden. 2022 Penumbra, Inc. www.penumbrainc . Introduction. DISCUSSION Neuron 6F Select; Neuron 5F Select; DDC; Ruby Coil. Penumbra Select catheters do not have hydrophilic coating Neuron 5 F Select | 120/130 cm.040" I 5F Support Zone Max Zone 5.5 F (.070") OD Distal Flexible Zone 25 cm 9 cm 5.5F 5 F Select | 120/130 cm Designed to deliver soft-tipped BENCHMARK 071 and Neuron 070 Intracranial Access Catheters Not designed to deliver 6 F Long Sheath Please email [email protected] or call us at 877-663-8686 and we will try to locate the product with our suppliers. This report is associated with mfr report number: 3005168196-2020-00849. Physician was using penumbra neuron select 6f catheter in a routine procedure. Register to see more details. PNS5F130SIM: Penumbra Neuron 5F 040 Select Catheter 130/9cm SIMIn-Date & Expired Penumbra Guiding Catheters. 5F Select Catheter: 130cm, BER. BMK6F95BER120. Medical Coding. All Electrophysiology (EP) Catheters Ablation - Irrigated Ablation - Non-Irrigated Steerable Irrigation . Penumbra JET Reperfusion Catheters; ACE Reperfusion Catheters; 5MAX and 4MAX Reperfusion Catheters.025 (.635 mm) ID; 2.95 F (.983 mm) proximal OD, 2.6 F (.867 mm) distal OD To start viewing messages, select the forum that you want to visit from the selection below.. Forums. Intended for the introduction of interventional devices into the peripheral, coronary and neuro vasculature. Penumbra, Inc. (NYSE: PEN) today announced that it is voluntarily recalling all configurations of the Penumbra JET 7 Reperfusion Catheter with Xtra Flex technology (JET 7 Xtra Flex). PNS6F105BER 6 F Select Catheter, 105 BER 105 cm PNS6F125SIM 6 F Select Catheter, 125 SIM 125 cm Optimized shaft for support throughout aortic arch. Background: Mechanical thrombectomy is the standard therapy in patients with acute ischemic stroke (AIS). Messages 8 Location Creswell, OR Best answers 0. Once that was cleared, a Neuron Select catheter (Penumbra, Inc.) was used to obtain access to the distal branches, where thrombus was still present. The Glidesheath Slender sheath is exchanged out, and the BGC is advanced over a 6F Sim Select intermediate catheter (Penumbra, Alameda, California, USA). K083 125 /2 I Nov2008 Neuron Select Catheter 070 Penumbra, Inc. kifl396 9.7 Device Description The Neuron MAX System is an additional configuration to the currently available Neuron Intracranial Access System. The company announced the recall after the market closed Tuesday. Full radiopaque distal shaft. Indications, Safety, and Warnings. KANSAS CITY, MO, October 24, 2009 /24-7PressRelease/-- On May 29, 2009, the Food and Drug Administration and Penumbra Inc. notified healthcare workers that a Class I recall was beginning for the Penumbra Neuron 5F Select Catheter.Penumbra, Inc. manufactures the catheter in question. Indigo System CAT7 Aspiration Catheter with Lightning Intelligent Aspiration powered by Penumbra ENGINE is now commercially available in the U.S. . Penumbra and FDA notified healthcare professionals of the Class 1 recall of the Neuron 5F Select Catheter, used to remove blood clots or foreign objects from blood vessels. The primary aim of our study was to compare the procedural efficacy of the direct aspiration technique, using Penumbra ACE TM aspiration catheter, and the stent retriever technique, with a Solitaire TM FR stent. I have worked with the penumbra catheter, it's an aspiration catheter . Write a review. Benchmark 071 Catheter: 95cm, Straight. It is intended for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusions. Results of EXTRACT-PE Trial presented at Vascular InterVentional Advances (VIVA) Annual Meeting Penumbra, Inc. (NYSE: PEN), a global healthcare company focused on innovative therapies, today announced that the EXTRACT-PE trial successfully met the primary endpoints, demonstrating the safety and efficacy of the Indigo Aspiration System for aspiration mechanical thrombectomy in patients with . Individual Coils; Delivery Microcatheter; Detachment Handle . The use of the 6F intermediate catheter facilitates a smooth transition with minimal step off between the skin and the BGC and, usually, no skin incision is necessary. Optimized shaft for support throughout aortic arch. Price: $43.00 EACH. . . 10 manufacturers with a similar name Learn more . Full radiopaque distal shaft. We attempted to deliver the Neuron MAX 088 guide sheath over a 125-cm Simmons Select catheter into the left ICA. Nov 29, 2021 #3 4 -7 Recent studies have suggested that MAT . PNS5F130H1: Penumbra Neuron 5F 040 Select Catheter 130/9cm H1 (No Box) In-Date Penumbra Guiding Catheters Photos are for illustration purposes only and may not depict the exact item. Neuron Select Catheter - Berenstein - 6Fr x 125cm x .040" Penumbra System. On December 15, 2020, Penumbra, Inc. issued an "urgent recall" of its JET 7 Xtra Flex catheter, and JET 7MAX configuration (JET 7 Xtra Flex catheter attached to the MAX Delivery Device). As part of the Indigo Aspiration System, the Indigo Aspiration Catheters and Separators are indicated for the removal of fresh, soft emboli and thrombi from vessels of the . There are no reviews yet, would you like to submit yours . PNS5F130H1: Penumbra Neuron 5F 040 Select Catheter 130/9cm H1 (No Box) In-Date Penumbra Guiding Catheters Photos are for illustration purposes only and may not depict the exact item. Select catheter (Penumbra, Inc.) was used to obtain access to the distal branches, where thrombus was still present. Some surgeons have alleged that while they attempted to remove blood clots from patients' brains, Penumbra's newest catheter would occasionally break or . The Penumbra System is a fully-integrated system designed specifically for mechanical thrombectomy. 6F Select Catheter. 3MAX Reperfusion Catheter. $649.00 box of 1 - Penumbra # BMK6F95BER120 - Penumbra Benchmark 071 Intracranial Access Catheter Kit Penumbra, Inc. (Neuro) Penumbra System Reperfusion Catheter JET 7, JET D, ACE, 5MAX, 4MAX, 3MAX, 026 6 (Penumbra JET 7, Penumbra JET D, ACE and 5MAX require 8-F short sheath or 6-F long sheath) 0.014-0.016: 132-160: Direct aspiration and separator-assisted clot debulking if needed Please email [email protected] or call us at 877-663-8686 and we will try to locate the product with our . Benchmark 071 Catheter: 105cm, MP. Due to a manufacturing error, the catheters may contain pin holes and exposed wire braids which may result in a brain clot or a blood vessel puncture, and this may lead to . PENUMBRA, INC. NEURON SELECT CATHETER 6F DQY: Back to Search Results: Model Number PNS6F125BER: Device Problem Break (1069) Patient Problem No Clinical Signs, Symptoms or Conditions (4582) Event Date 01/05/2022: Event Type malfunction Event Description The patient was undergoing a medical procedure in the pulmonary artery using a neuron select . 1 2 3 5 6 Neuron 6Fr Select Catheter - Sim-V - 6Fr x 125cm x 8cm x .040" Penumbra System. Neuron 6Fr Select Catheter - Simmons - 6Fr x 125cm x 8cm x .040" Penumbra System. Register. The Penumbra Select Catheter is designed to assist in the navigation into the neurovasculature. Penumbra and FDA notified healthcare professionals of the Class 1 recall of the Neuron 5F Select Catheter, used to remove blood clots or foreign objects from blood vessels. Introduce the preloaded system over a guidewire and advance to a straight section of the abdominal aorta. In Stock! The Neuron Max System provides a larger lumen to assist in utilizing contrast injections to further optimize anatomical visualization . number of bacteria on a surface that has not been sterilized. Neuron Select Catheter - SIM - 5Fr x .040" x 130cm - Non-Expired: 5Fr x .040" x 130cm $200.00. 6 F Select Catheters Tip Shape Working Length Distal Flexible Zone Inner Diameter Catalog Number Description (cm) (cm) (in.) This catheter is used to remove foreign objects or blood clots from blood vessels. 5F A 3MAX catheter (Penumbra, Inc.) was used to provide support to navigate ACE64 to the thrombus. Add to cart. PNS5F130SIM: Penumbra Neuron 5F 040 Select Catheter 130/9cm SIM. clot capture capability through four intraluminal chambers and is optimized for use with aspiration delivered by ACE catheters or the Penumbra JET 7 Reperfusion catheter: Guiding catheter system offered with inner select catheters with a hydrophilic coating for navigation and vessel selection: 5/6: 95: 0.059/0.071: Yes: Chaperon catheter, no; inner select catheter, yes Class I Recall for Select Catheters Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious injury or death.. 2022 Penumbra, Inc. www.penumbrainc . UPC: Current Stock: This item is out of stock. . Description Additional Information Reviews (0) Reviews. Penumbra Neuron 5F Select Catheter, Neuro Deliver/Intracranial Access System Catheter, manufactured by Penumbra, Inc., Alameda, CA. 3MAX Reperfusion Catheter. 1: Add . If you or somebody you know was injured by a defective Penumbra Jet 7 catheter, you should contact our lawyers immediately for a free case consultation. Neuron Select Catheter - Simmons - 6Fr x .040" x 125cm - Non-Expired Penumbra System . I have found these catheter require more distal intracranial position for stability and are best positioned in conjunction with a Penumbra Select diagnostic catheter and 035 in Glidewire. 3MAXCKIT 3MAX Reperfusion Catheter + Penumbra Hi-Flow Tubing 4.7 (.062) 1.27 .043 .035 160 Reperfusion Catheters The Penumbra CAT RX appears to be safe and highly effective at thrombus removal . 5F Select Catheter: 120cm, BER. The Neuron 5F Select Catheter is used to remove blood clots or foreign objects from blood vessels. Enables primary access and atraumatic placement into desired vessel without an over-the-wire exchange; Useful for diagnostic angiogram - .040" lumen; Stainless steel braided proximal shaft for support and torque response with a soft polymer distal shaft to enable atraumatic vessel selection Straight, 125 cm BER 6 F Select Catheter 90 BMX9690SIM125 BENCHMARK BMX96 Access System, 90 cm Straight, 125 cm SIM 6 F Select Catheter 90 . Compatible with Penumbra 5 F (1.65 mm) Select Catheters for Rapid Primary Access delivery to final position, eliminating an over-the-wire exchange; Neuron 053.053 (1.35 mm) lumen for primary device delivery; 6 F (2.03 mm) proximal to 5 F (1.65 mm) distal tapered OD; 5 F Select Catheter Allows for easy selection off of arch into desired vessel PENUMBRA: SEP3 . Optimized proximal shaft for support throughout aortic arch. Neuron MAX 088 is designed for neurovascular use delivering MAX support for today's most advanced treatment options. Distal tip damage in conjunction with pressurization or contrast injection may result in . You must be . Secondarily, we investigated treatment-dependent and treatment-independent . pica catheter: PENUMBRA, INC. . Description Additional Information Reviews (0) Reviews. (mm) PNS6F105H1 6 F Select Catheter, 105 H1 105 9 .040 (1.02) PNS6F105BER 6 F Select Catheter, 105 BER 105 9 .040 (1.02) PNS6F125H1 6 F Select Catheter, 125 H1 125 9 .040 (1.02) Please email [email protected] or call us at 877-663-8686 and we will try to locate the product with our suppliers. Individual Coils; Delivery Microcatheter; Detachment Handle . Photos are for illustration purposes only and may not depict the exact item. Attention Lawyers: We consider a referral from another law . Aspiration thrombectomy continues to have clinical benefit in modern cardiac catherization laboratories with use in select cases. Full radiopaque distal shaft. Penumbra Select Catheter. ALAMEDA, Calif.--(BUSINESS WIRE)-- Penumbra, Inc. (NYSE: PEN), a global healthcare company focused on innovative therapies, announced that the CHEETAH clinical study of its Indigo System CAT RX Catheter successfully met the primary endpoint and demonstrated high rates of blood clot removal, blood flow restoration and myocardial perfusion .