CLASS I ONGOING Device recall · Reported 9 Aug 2023 · FDA Enforcement Report

Impella RP Flex with SmartAssist intracardiac microaxial recalled

Abiomed is recalling Impella RP Flex with SmartAssist intracardiac microaxial blood pump, Product Number, distributed nationwide in the US. The recall was initiated on 29 Jun 2023 and the FDA has classified it as Class I.

Check your package

Lot, batch or date codesUDI-DI: 00813502012811; Serial Numbers: 409541 409542 409544 411379 416645 416646 416647 416649 418933 418939 418940 419489 421953 421955 422974 422978 423999 425596 428726 428730 429616 429617 429623 429646 429648 429649 429650 429651 429652 429654 430363 430365 430366 430367 430923 430929 430931 431099 431106 431532 431535 431844 431846 431847 431848 431850 431868 431869 431870 432394 432395 432396 432397 432398 432400 432401 432402 432643 432644 432645 432648 432651 433755 433756 434540

Quantity recalled166 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2281-2023
FDA event ID: 92411
Recalling firm: Abiomed, Danvers, MA
Classification: Class I
Status: Ongoing
Recall initiated: 29 Jun 2023
FDA classified: 3 Aug 2023
Reported: 9 Aug 2023
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Heart & Vascular Devices

Timeline

29 Jun 2023	Recall initiated by company
3 Aug 2023	Classified by FDA	+35 days
9 Aug 2023	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

Impella RP Flex with SmartAssist intracardiac microaxial blood pump, Product Number 1000323

Where it was distributed

US Nationwide distribution including in the states of AR, CA, FL, GA, LA, MA, MI, MO, NC, NJ, NY, OH, OR, SC, TX, and WI.

Nationwide Arkansas California Florida Georgia Louisiana Massachusetts Michigan Missouri North Carolina New Jersey New York Ohio Oregon South Carolina Texas Wisconsin

Questions about this recall

Why was it recalled?

Which lots are affected?

UDI-DI: 00813502012811; Serial Numbers: 409541 409542 409544 411379 416645 416646 416647 416649 418933 418939 418940 419489 421953 421955 422974 422978 423999 425596 428726 428730 429616 429617 429623 429646 429648 429649 429650 429651 429652 429654 430363 430365 430366 430367 430923 430929 430931 431099 431106 431532 431535 431844 431846 431847 431848 431850 431868 431869 431870 432394 432395 432396 432397 432398 432400 432401 432402 432643 432644 432645 432648 432651 433755 433756 434540

Where was it sold?

US Nationwide distribution including in the states of AR, CA, FL, GA, LA, MA, MI, MO, NC, NJ, NY, OH, OR, SC, TX, and WI.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class I mean?

Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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