Penumbra RED 68 Reperfusion Catheter
Penumbra is recalling the RED 68 Reperfusion Catheter due to a manufacturing issue that may cause the device to fracture during use.
Healthcare providers should immediately stop using the affected catheters and follow the instructions provided in the manufacturer's urgent medical device recall notification to return the products.
Why it was recalled
Penumbra is recalling the RED 68 Reperfusion Catheter due to a manufacturing issue that may cause the catheter to fracture during use. This defect poses a risk of serious injury or complications during medical procedures.
Is mine affected?
Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.
Penumbra System RED 68 Reperfusion Catheter REF: RED68KIT
- Lot code
- H00008699, H00008701, H00008702, H00008703, C00020038
- UDI-DI
- 00815948024113
Where it was sold
Distributed nationwide.
Timeline
- Firm initiated recall
- Publicly announced
- Listed on Recall Canary
- Summary updated
Official source
Other Manufacturing Deviation recalls
Editorial summary by Recall Canary · summary updated 2026-07-22 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification