Recall Z-2770-2026 ยท NRY Catheter, Thrombus Retriever
Penumbra, Inc.
Penumbra System RED 68 Reperfusion Catheter REF: RED68KIT
| Date | Jul 21, 2026 (initiated Jun 3, 2026) |
| Status | Open, Classified |
| Reason | Due to manufacturing issues, reperfusion catheters may fractures |
| Root cause | Under Investigation by firm |
| Action | On June 2, 2026, Penumbra issued a Urgent Medical Device Recall Notification to affecte consignees via FedEx. Penumbra asked consignees to take the following actions: 1. Review inventory and remove affected units from inventory and place in quarantine for return. 2.Complete and return the response form to notifications@penumbrainc.com. Your Penumbra representative will work with you directly to arrange return and credit of affected devices. If you do not have any affected product, please still complete the response form and return. 3. Share recall notification with all users of the produ |
| Distribution | Worldwide - US Nationwide distribution including in the states and territories of AK, AL, AE, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KY, MA, MD, MI, MN, MO, MS, NC, ND, NE, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, Puerto Rico and the countries of Brazil, Canada, Colombia, Ecuador, In |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K211411 | Penumbra System (RED 68 Reperfusion Catheter) Penumbra, Inc., Jul 1, 2021 |