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

Impella catheters - Intravascular micro axial blood pumps that support a patient's circulatory system. (1) Product Code 005042 - Impella 2.5 (2) Product Code 005062 - Impella 5.0 (3) Product Code 005082- Impella LD (7) Product Codes 0550-0008 and 1000100 - Impella 5.5 with SmartAssist (8) — recall Z-0980-2024

U.S. FDA — Device Enforcement · United States · 2023-12-27 · Class I

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0980-2024
Date of alert: 2023-12-27
Country / jurisdiction: United States
Risk level: Class I
Risk type: recall
Brand: Abiomed, Inc.
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 00813502011081

Reported risk: IFU has been updated to include warnings about the risk of the inlet perforating through the myocardial wall of the left ventricle due to operator handling.

Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

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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.

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