Class IIOngoingZ-2770-2026
Penumbra, Inc. recalls Penumbra System RED 68 Reperfusion Catheter REF: RED68KIT
Due to manufacturing issues, reperfusion catheters may fractures
Penumbra, Inc.CAJul 29, 2026
Catheter, Thrombus Retriever recalls
Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 1–3 of 3 recalls
Class IOngoingZ-1512-2025
Qapel Medical Inc. recalls Hippo 072 Aspiration System including Cheetah Delivery Tool and Aspiration Tubing
Aspiration catheter distal tip features and characteristics may not be in the scope of FDA clearance; tip detachment, vessel rupture, and vasospasm could occur.
Qapel Medical Inc.CAApr 16, 2025
Class IIOngoingZ-1234-2025
Scientia Vascular, Inc. recalls Socrates 38 Aspiration Catheter 127 cm length REF SC038-127-001 The Socrates Aspira…
Due to manufacturing non-conformance that resulted in channels in the seal on the packaging pouch. As a result, this could potential create a breach in the sterile barrier.
Scientia Vascular, Inc…UTMar 5, 2025