Z-3331-2026

Brand Name: Penumbra System (RED 62 Reperfusion Catheter) Product Name: Penumbra System (RED 62 Reperfusion...

Name: Z-3331-2026 Brand Name: Penumbra System (RED 62 Reperfusion Catheter) Product Name: Penumbra System (RED 62 Reperfusion...
Creator: Penumbra Inc.
Published: 2026-07-24
License: https://open.fda.gov/license/

Penumbra Inc. / initiated 2026-07-24 / Open, Classified

FDA source

Recall record

Recall number: Z-3331-2026
Status: Open, Classified
Initiated: 2026-07-24
Posted: 2026-09-29
Recalling firm: Penumbra Inc.
Product: Brand Name: Penumbra System (RED 62 Reperfusion Catheter) Product Name: Penumbra System (RED 62 Reperfusion Catheter) Model/Catalog Number: THNDRRED62SKIT Software Version: N/A Product Description: Product common name: Percutaneous catheter A complete product description is provided in Attachment 1 (HHE-2026-002 RED62). Component: Penumbra System
Product code: NRY Catheter, Thrombus Retriever
Reason for recall: Due to manufacturing issues reperfusion catheters may fracture.
FDA root cause: Under Investigation by firm
Action: On 07/24/2026, an "URGENT: VOLUNTARY MEDICAL DEVICE RECALL NOTIFICATION" was sent via email and FedEx Priority Overnight to customers informing them that Penumbra has identified an issue (frature) in the lot H00007856 of the Penumbra System RED 62 Reperfusion Catheter (RED 62). Actions Customers need to take: " Share this Recall Notification with all users of the product within your facility " Review inventory for the specified lot listed above " If you do have inventory of the specified lot listed above, remove affected units from inventory and place in quarantine for return to Penumbra, Inc. Complete and return the Product Identification/Return Notification to [email protected] within 3 business days. Your Penumbra Sales Representative will work with you directly to arrange return and credit. " If you do not have inventory of the specified lot listed above, complete and return the Product Identification/Return Notification form to [email protected] within 3 business days. No further action is required. For questions - contact Penumbra Sales Representative or email at [email protected].
Quantity in commerce: 43
Distribution: US Nationwide distribution in the states of AL, CA, CO, FL, LA, NC, NY, TX, UT, WI.
Product codes and lots: Lot Code: UDI: 00815948024359 Lot Number: H00007856

Product code NRY

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-10-02. View this recall on fda.gov (opens on fda.gov)