Class IOngoingZ-2682-2026
Abiomed, Inc. recalls ABIOMED Impella CP Set
A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers.…
Abiomed, Inc.MAJul 22, 2026
Introducer, Catheter recalls
Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 13–24 of 33 recalls
Class IOngoingZ-2681-2026
Abiomed, Inc. recalls ABIOMED Impella RP Flex with SmartAssist Set
A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers.…
Abiomed, Inc.MAJul 22, 2026
Class IOngoingZ-2680-2026
Oscor Inc. recalls Abiomed REF: 0052-3006
Due to manufacturing issues, there is a potential for the 14Fr and 23Fr introducer sheaths to leak from the sidearm, under the sheath cap, and along the hub score lines in the hub region.
Oscor Inc.FLJul 22, 2026
Class IOngoingZ-2679-2026
Oscor Inc. recalls Abiomed REF: 0052-3021
Due to manufacturing issues, there is a potential for the 14Fr and 23Fr introducer sheaths to leak from the sidearm, under the sheath cap, and along the hub score lines in the hub region.
Oscor Inc.FLJul 22, 2026
Class IOngoingZ-2678-2026
Oscor Inc. recalls Abiomed REF: 0052-3025
Due to manufacturing issues, there is a potential for the 14Fr and 23Fr introducer sheaths to leak from the sidearm, under the sheath cap, and along the hub score lines in the hub region.
Oscor Inc.FLJul 22, 2026
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
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