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?
This recall covers the product below. If you have it, yours is affected.
Penumbra System RED 68 Reperfusion Catheter REF: RED68KIT
Official source
Editorial summary by Recall Canary · last updated 2026-07-22 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification