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Penumbra Inc. FDA Recalls
2 recalls on file across devices, 0 of them Class I and 2 still open. Matched by name to PEN.
Newest first
Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| Brand Name: Penumbra System (RED 62 Reperfusion Catheter) Product Name: Penumbra System (RED 62 Reperfusion Catheter) Class IIJul 24, 2026Due to manufacturing issues reperfusion catheters may fractu |
| Penumbra System RED 68 Reperfusion Catheter REF: RED68KITClass IIJun 3, 2026Due to manufacturing issues, reperfusion catheters may frac |