Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-2961-2024 — Impella 5.5 with SmartAssist Set, EU; Product Code: 0550-0002;

U.S. FDA — Device Enforcement · United States · 2024-08-05 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2961-2024
Date of alert
2024-08-05
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Abiomed, Inc.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
00813502011630
Reported risk: A potential device interaction between the Shockwave Coronary IVL Catheter and left-sided Impella Pumps during coronary interventions. Currently there is no Abiomed labeling (IFU etc.) content related to this potential interaction, so Abiomed will update the IFU to include information on this potential device interaction.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.