Penumbra System RED 68 Reperfusion Catheter REF: RED68KIT
FDA device recall Z-2770-2026 · posted 2026-07-21 · Open, Classified
Recall details
- Recalling firm
- Penumbra, Inc.
- Reason for recall
- Due to manufacturing issues, reperfusion catheters may fractures
- Action taken
- 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 product within your facility.
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- NRY
- 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
- Date initiated
- 2026-06-03
- Date posted
- 2026-07-21
- Location
- Livermore, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Penumbra System (RED 68 Reperfusion Catheter) (K211411) | Penumbra, Inc. | 2021-07-01 |