Penumbra Inc. recall (Class II): Brand Name: Penumbra System (RED 62 Reperfusion Catheter) Product Name: Penumbra System (RED 62 Reperfusion Ca…
Due to manufacturing issues reperfusion catheters may fracture. Product: 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
- Published by source
- 2026-10-07
- First seen by Reality Radar
- 2026-10-20
- Last verified
- 2026-10-20
Affected
- Manufacturer
- Penumbra Inc.
- Products
- Brand Name: Penumbra System (RED 62 Reperfusion Catheter) Product Name: Penumbra System (RED 62 Reperfusion Catheter) Model/Catalog Number: THNDRRED62SKIT Softw
Whether your exact unit is affected depends on the model, serial number and region in the official notice.
What the official notice says
Risk: Class II: Due to manufacturing issues reperfusion catheters may fracture.
Is this affecting you?
Add what you own or use and Reality Radar will tell you when official changes match it — with evidence and next steps.
Sources
- openFDA Recall Enforcement Reports Tier A · official published 2026-10-07
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