Use cautionMedical device recall · FDA · Published June 29, 2023
Abiomed Impella RP Flex SmartAssist Pump Recall: Thrombus Risk
Abiomed recalls Impella RP Flex with SmartAssist pumps due to higher risk of blood clots forming and breaking loose, potentially causing reduced blood flow or hemolysis.
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
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Contact the company
📍Recalling firmAbiomed, Inc.22 &, 24 Cherry Hill Dr · Danvers, MA 01923-2575
✎ GovInfoNow plain-language explainer
Abiomed is recalling certain Impella RP Flex with SmartAssist intracardiac blood pumps because they can form blood clots that may break free and cause reduced blood flow or hemolysis. This risk is serious for patients using the device for heart support. Read more at govinfonow.com/recall/57762-abiomed-impella-rp-flex-smartassist-pump-recall-thrombus-risk.
“Abiomed Impella RP Flex SmartAssist Pump Recall: Thrombus Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/57762-abiomed-impella-rp-flex-smartassist-pump-recall-thrombus-risk. Based on FDA recall #Z-2281-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2281-2023%22&limit=1).
The FDA announced on June 29, 2023, that Abiomed, Inc. is voluntarily recalling the Impella RP Flex with SmartAssist intracardiac microaxial blood pump due to a higher than expected rate of thrombus formation. The hazard poses risks of reduced flow, loss of support, or hemolysis if deposits break free and enter the device.
How to tell if you have it
Brand: Abiomed
Product: Impella RP Flex with SmartAssist intracardiac microaxial blood pump
Distribution: US Nationwide including AR, CA, FL, GA, LA, MA, MI, MO, NC, NJ, NY, OH, OR, SC, TX, and WI
The hazard
According to the FDA, 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.
Context
GovInfoNow's records show Abiomed, Inc. has 28 other recalls on record since September 4, 2019. Other recent recalls of similar products include the Fresenius Kabi Ivenix Infusion Pump Recall (November 3, 2025), the ICU Medical Pulsator Arterial Blood Sampling Kit Recall (December 19, 2025), and the Boston Scientific Imager II Angiographic Catheters Recall (August 24, 2026).
How to tell if you have this one
Check if your Impella RP Flex pump has the Product Number 1000323 and the listed serial numbers or UDI-DI code 00813502012811. The device is used for heart support in medical settings.
Brand
Abiomed
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Device Details
Verify your pump's Product Number (1000323) and serial numbers from the recall list.
Contact Healthcare Provider
Talk to your doctor or hospital about the recall and next steps for your specific situation.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 16 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “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.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Arkansas, California, Florida, Georgia, Louisiana, Massachusetts, Michigan, Missouri, New Jersey, New York, North Carolina, Ohio, Oregon, South Carolina, Texas, Wisconsin.
Recall timeline
FDA published this recall 41 days after the firm started it.
1Firm started the recall
2FDA classified it Class I
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-2281-2023 (June 29, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2281-2023 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.