Reported Sep 11, 2024 · Ongoing
ImpellaCP SmartAssistSetAPAC, Delo1895; Product Code: 1000302;
Abiomed, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Abiomed, Inc. · 24 Cherry Hill Dr · Danvers, MA · 01923-2575
Is this the product you have?
- ImpellaCP SmartAssistSetAPAC, Delo1895
- Product Code1000302
- Lot codes and dates
4 of 4 products
Products covered by this recall Model / number Barcodes Product as published 1000302— — 00813502012767UDI-DI: 00813502012767 — Serial Numbers: 392664 392661 392660 392665 392666 392667 392668 392669 — Batch Numbers: 2023263121 2023263124 2023263125 2023269641 2023269670 2023269672 2023269673 2023269674 - Amount recalled
- 8 units
This recall covers 18 products
The agency filed one notice per product. You are reading one of them; the other 17 are below.
5 more are in the archive.
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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