Official recall notice
FDA DeviceClass IINotable
FDA Recall: Penumbra System RED 68 Reperfusion Catheter REF: RED68KIT
- Recall date
- 2026-07-29
- Brand
- Penumbra, Inc.
- Category
- Medical Device
- FDA class
- Class II
Why it was recalled
Hazard
Due to manufacturing issues, reperfusion catheters may fractures
Product description
Due to manufacturing issues, reperfusion catheters may fractures
Affected products
UDI: 00815948024113/Lots: H00008699, H00008701, H00008702, H00008703, and C00020038