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
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.
The pump can develop blood clots that may break loose and enter the device, leading to reduced blood flow, loss of support, or hemolysis (damage to red blood cells). This happens due to higher than expected clot formation rates in the device.
Patients using the recalled Impella RP Flex pumps for heart support are most at risk. The specific model numbers and serial numbers are listed in the recall notice.
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.
Verify your pump's Product Number (1000323) and serial numbers from the recall list.
Talk to your doctor or hospital about the recall and next steps for your specific situation.
Product Number 1000323 with the listed serial numbers and UDI-DI code 00813502012811.
Higher than expected blood clot formation can cause clots to break free and enter the pump, leading to reduced blood flow or hemolysis.
The recall does not require immediate stop use; contact your healthcare provider for guidance.
We’ve drafted a message you can send Abiomed to request your refund or repair — edit it as you like.
Subject: Recall Z-2281-2023 — Abiomed Abiomed Hello, I own a Abiomed that is covered by recall Z-2281-2023 from Abiomed. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
