Reported Aug 9, 2023 · Ongoing
Impella RP Flex with SmartAssist intracardiac microaxial blood pump, Product Number 1000323
Abiomed, Inc.
High riskUsing this product could cause serious injury, illness or death — stop using it now.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. · 22 & · Danvers, MA · 01923-2575
Is this the product you have?
- Impella RP Flex with SmartAssist intracardiac microaxial blood pump, Product Number 1000323
- Lot codes and dates
- UDI-DI00813502012811
- Serial Numbers
65 of 65 codes
409541409542409544411379416645416646416647416649418933418939418940419489421953421955422974422978423999425596428726428730429616429617429623429646429648429649429650429651429652429654430363430365430366430367430923430929430931431099431106431532431535431844431846431847431848431850431868431869431870432394432395432396432397432398432400432401432402432643432644432645
- Amount recalled
- 166 units
Where it was sold
Why it was recalled
Stop using this product now
A higher than expected rate of thrombus formation or deposition has been observed. The risk is for thrombus formations or deposits on indwelling central venous lines or cannulas may break free and enter into the Impella RP Flex, resulting in reduced flow, loss of support, or hemolysis
Using this product could cause serious injury, illness or death — stop using it now.
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.