Class IOngoingZ-2602-2026
Abiomed, Inc. recalls Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14Fr Low…
Potential for thrombus formation during prolonged use of the introducer.
Abiomed, Inc.MAJul 1, 2026
Introducer, Catheter recalls
Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 1–12 of 16 recalls
Class IOngoingZ-2601-2026
Abiomed, Inc. recalls Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14Fr Low…
Potential for thrombus formation during prolonged use of the introducer.
Abiomed, Inc.MAJul 1, 2026
Class IOngoingZ-2600-2026
Abiomed, Inc. recalls Abiomed 14 Fr x 25 cm Low Profile Introducer Kit for Impella CP. Impella Set Product Co…
Potential for thrombus formation during prolonged use of the introducer.
Abiomed, Inc.MAJul 1, 2026
Class IOngoingZ-2599-2026
Abiomed, Inc. recalls Abiomed 14 Fr x 13 cm Low Profile Introducer Kit for Impella CP. Impella Set Product Co…
Potential for thrombus formation during prolonged use of the introducer.
Abiomed, Inc.MAJul 1, 2026
Class IOngoingZ-2385-2026
ARROW INTERNATIONAL, LLC recalls Description/REF: ACCESS TRAY/GU-04020
Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if ster…
ARROW INTERNATIONAL, L…NCJun 24, 2026
Class IIOngoingZ-2202-2026
Becton, Dickinson And Company recalls Swan-Ganz Catheter
Catheters may, due to a manufacturing process and material changes, leak/break from the (blue) proximal injectate lumen hub, which may lead to infection, medication loss, and/or blood loss.
Becton, Dickinson and…CAMay 27, 2026
Class IOngoingZ-1577-2026
Merit Medical Systems, Inc. recalls 16F Dual Valved Splittable Sheath Introducer (bulk
16F dual-valved splittable sheath introducer due to a design defect, may not split as intended, which may result in hemorrhage, foreign bodies, procedure delay, embolization/thrombosis, impaired catheter function, loss o…
Merit Medical Systems,…UTApr 1, 2026
Class IIOngoingZ-0995-2026
Cook Incorporated recalls R¿sch-Uchida Transjugular Liver Access Sets
Cook Medical identified that products supplied in the affected device lots may have been manufactured out of specification.…
Cook IncorporatedINDec 31, 2025
Class IIOngoingZ-0994-2026
Cook Incorporated recalls Ring Transjugular Intrahepatic Access Sets
Cook Medical identified that products supplied in the affected device lots may have been manufactured out of specification.…
Cook IncorporatedINDec 31, 2025
Class IIOngoingZ-0993-2026
Cook Incorporated recalls Flexor Check-Flo Introducers and Sets
Cook Medical identified that products supplied in the affected device lots may have been manufactured out of specification.…
Cook IncorporatedINDec 31, 2025
Class IIOngoingZ-2532-2025
Contract Medical International GmbH recalls Brand Name: Fortress Introducer Sheath System Product Name: Fortress Introducer Sheath…
Units may have been packaged with an incorrect pouch label, which lists the reference number and unique device identifier of the 4F version of the device, rather than the packaged 6F version.
Contract Medical Inter…Sep 17, 2025
Class IIOngoingZ-1787-2025
Cook Incorporated recalls Check=Flo Performer Introducer
Cook Medical identified that devices from the affected device lots may contain the incorrectly sized introducer sheath.
Cook IncorporatedINMay 28, 2025