Reported Sep 11, 2024 · Ongoing
Impella CP Pump 371 Set, Clinical Trial; Product Code: 0048-0040;
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 371 Set, Clinical Trial
- Product Code0048-0040
- Lot codes and dates
4 of 4 products
Products covered by this recall Model / number Barcodes Product as published 0048-0040— — 00813502011739UDI-DI: 00813502011739 — Serial Numbers: 370089 370091 370090 370074 370093 401804 401805 401811 401806 — Batch Numbers: 2023172492 2023172497 2023172494 2023172500 2023172499 2023255511 2023255513 2023255522 2023255514 - Amount recalled
- 9 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.
Free recall alerts
Get alerted about new Abiomed, Inc. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.