Reported Jul 29, 2026 · Ongoing
Penumbra System RED 68 Reperfusion Catheter REF: RED68KIT
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. · 6262 Patterson Pass Rd Ste A · Livermore, CA · 94550-9576
Is this the product you have?
- Penumbra
- System RED 68 Reperfusion Catheter REFRED68KIT
- Lot codes and dates
- UDI
00815948024113/Lots: H00008699H00008701H00008702H00008703and C00020038
- UDI
- Amount recalled
- N/A
Where it was sold
Why it was recalled
Due to manufacturing issues, reperfusion catheters may fractures
This product could cause temporary or reversible health problems — stop using it.
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