Abiomed recalls Impella 5.5 with SmartAssist catheters due to reported purge leaks. Affected units have specific serial numbers and product codes.
The Impella 5.5 pump experienced a heightened complaint rate for purge leaks.
Abiomed is recalling certain Impella 5.5 with SmartAssist catheters because they have experienced a higher rate of purge leaks. This could lead to potential complications for patients using the device.
The pump has a heightened complaint rate for purge leaks, which means fluid may escape the device. While this is a reported issue, it does not indicate an immediate risk of serious injury or death in normal use.
Patients using the recalled Impella 5.5 with SmartAssist catheters for circulatory support are affected. Healthcare providers who have these specific models in their inventory are most at risk.
Check if your Impella 5.5 catheter has the product numbers 1000211 (Impella 5.5 JP), 0550-0002 (Impella 5.5 Smart Assist), or 0550-0008 (Impella 5.5 with SmartAssist Set, US). Look for the specific serial numbers listed in the recall notice.
Verify your Impella 5.5 catheter's product number and serial number against the list provided in the recall notice.
It is an intravascular micro axial blood pump that supports a patient's circulatory system.
Check if your catheter has product numbers 1000211, 0550-0002, or 0550-0008 and the specific serial numbers listed in the recall notice.
The recall does not specify a remedy, so contact Abiomed directly 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-1590-2023 — Abiomed Abiomed Hello, I own a Abiomed that is covered by recall Z-1590-2023 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.
