Reported Oct 7, 2026 · Ongoing · Updated Oct 13, 2026
Brand Name: Penumbra System (RED 62 Reperfusion Catheter) Product Name: Penumbra System (RED 62 Reperfusion Catheter)…
Penumbra Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Penumbra Inc. · 1 Penumbra · Alameda, CA · 94502-7610
Is this the product you have?
- Brand NamePenumbra System (RED 62
- Reperfusion Catheter) Product NamePenumbra System (RED 62 Reperfusion
- Catheter) Model/Catalog NumberTHNDRRED62SKIT
- Software VersionN/A
- Product DescriptionProduct
- common namePercutaneous catheter A complete product description is provided in Attachment 1 (HHE-2026-002 RED62)
- ComponentPenumbra System
- Lot codes and dates
- Lot CodeUDI: 00815948024359
- Lot NumberH00007856
- Amount recalled
- 43
Where it was sold
Why it was recalled
Due to manufacturing issues reperfusion catheters may fracture.
This product could cause temporary or reversible health problems — stop using it.
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