Reported Sep 11, 2024 · Ongoing
Impella 5.5 Set AU; Product Code: 1000361;
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 5.5 Set AU
- Product Code1000361
- Lot codes and dates
- Product Code1000361
- UDI-DI00813502012927
- Serial Numbers
425570425332425331463954463955476358476357481131481130481129485279485278485280480079483437466172A491829491830491831491832
- Batch Numbers
20242862812024286289202428629220243755052024375511202439883220243988332024413728202441387920244138822024431078202443115820244311712024431175202443165020244316522024431653202443165620244316732024431720
- Amount recalled
- 20 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.
Want the full recall guide?
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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