Penumbra RED 62 Reperfusion Catheter Recalled for Fracture Risk
Penumbra Inc. is recalling 43 RED 62 Reperfusion Catheters due to manufacturing issues that may cause the catheters to fracture.
What this means for you
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a structural defect (fracture) in a medical device, which aligns with the rubric criteria for a Severe rating (Score 4).
Plain-English summary
Penumbra Inc. is recalling 43 units of the Penumbra System (RED 62 Reperfusion Catheter), model THNDRRED62SKIT, due to manufacturing issues that may cause the catheters to fracture. The affected units are identified by Lot Number H00007856 and UDI 00815948024359.
The recall covers products distributed nationwide in the states of Alabama, California, Colorado, Florida, Louisiana, North Carolina, New York, Texas, Utah, and Wisconsin. The FDA has classified this recall as Class II, indicating that use of or exposure to the product may cause temporary or medically reversible adverse health consequences.
Healthcare providers and facilities should stop using the affected catheters and contact Penumbra Inc. for instructions on return or replacement. Patients who have received these devices should consult their healthcare provider if they experience any complications.
The recalled product
- 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…
- Manufacturer
- Penumbra Inc.
- Category
- Medical Device — Catheter
- Affected units
- 43
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot Code: UDI: 00815948024359 Lot Number: H00007856
Distribution
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