Brand Name: Penumbra System (RED 62 Reperfusion Catheter) recallZ-3331-2026 · Penumbra Inc. · initiated Jul 24, 2026
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Penumbra Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Due to manufacturing issues reperfusion catheters may fracture.
FDA root cause category: Under Investigation by firm
What the company is doing
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].
Recall details
- Recall number
- Z-3331-2026
- Status
- Open, Classified
- Initiated by the company
- Jul 24, 2026
- Posted by the FDA
- Sep 29, 2026
- Recalling firm
- Penumbra Inc.
- Quantity
- 43
- Product code
- NRY
- FDA submissions
- K203440, K250690
- Distribution
- US Nationwide distribution in the states of AL, CA, CO, FL, LA, NC, NY, TX, UT, WI.
Product description
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
Code information (models, lots, serial numbers)
Lot Code: UDI: 00815948024359 Lot Number: H00007856
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Thunderbolt + RED 62 THNDRRED62SKIT-APenumbra, Inc.1 recall1 death4 reports
Other devices under the same FDA submission
4 devices cleared under K203440, K250690 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- RED RED62SKIT-BPenumbra, Inc. · Catheter, Thrombus Retriever1 death36 reports
- RED RED62S-BPenumbra, Inc. · Catheter, Thrombus Retriever9 reports
- Thunderbolt + RED 72 THNDRRED72KIT-APenumbra, Inc.4 reports
- Thunderbolt + RED 68 THNDRRED68KIT-APenumbra, Inc.1 death3 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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