Recall Z-0851-2021 ยท NRY Catheter, Thrombus Retriever
Penumbra Inc.
Penumbra JET 7MAX KIT Penumbra JET 7 Reperfusion Catheter+ MAX Delivery Device + Hi-Flow Aspiration Tubing REF J7XKIT132 The Penumbra JET 7 Reperfusion Catheter with Xtra Flex technology (JET 7 Xtra Flex) is a component of the Penumbra system. JET 7 Xtra Flex delivers aspiration from the Aspiration Pump to the site of occlusion to assist in the efficient removal of thrombus from the neurovascula
| Date | Jan 18, 2021 (initiated Dec 15, 2020) |
| Status | Terminated |
| Reason | The catheter may become susceptible to distal tip damage during use. Distal tip damage in conjunction with pressurization of contrast injection may result in potential vessel damage, and subsequent patient injury or death. |
| Root cause | Process design |
| Action | On 12/15/2020, the firm posted a press release (https://www.penumbrainc.com/wp-content/uploads/2020/12/JET-7XF-15Dec20.pdf) and issued an "URGENT VOLUNTARY MEDICAL DEVICE RECALL NOTIFICATION" letter via FedEx informing customers that all configurations of their reperfusion catheters may become susceptible to distal tip damage during use. Distal tip damage in conjunction with pressurization or contrast injection may result in potential vessel damage, and subsequent patient injury or death. Customers are instructed to: 1. Share this recall notification with all users of the product within your |
| Quantity | 15 catheters |
| Distribution | Worldwide distribution: U.S. (nationwide) including states of: AL, AK, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO , MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, PA, Puerto Rico, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY. And O.U.S (countries) of: C |
| FDA record | Open on fda.gov |