Reported Sep 11, 2024 · Ongoing
Impella 5.5 with SmartAssist S2 Set, US; Product Code: 1000100;
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 with SmartAssist S2 Set, US
- Product Code1000100
- Lot codes and dates
- Product Code1000100
- UDI-DI00813502012828
- Serial Numbers
4,645 of 4,645 codes
417756417055417820417817417818416967416968417054417056417057417058417819417821417042416991417043417024417025417026417027417028417234417235417236416989416990416992416993417040417041416864416865416866416867416962416959416887416888416963417237417238416897416869416872416873416886416961416960417833416870416871416855416854416858417244417246417245416884416885417061
- Amount recalled
- 11,576 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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