Reported Sep 11, 2024 · Ongoing
Impella CP Pump Set, Japan; Product Code: 0048-0034-JP;
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?
- Impella CP Pump Set, Japan
- Product Code0048-0034-JP
- Lot codes and dates
- Product Code0048-0034-JP
- UDI-DI00813502011463
- Serial Numbers324303 323153 328083 328085
- Batch Numbers2022079852 2022079846 2022083745 2022083747
- Amount recalled
- 4 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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