Abiomed recalls Impella 5.5 with SmartAssist S2 devices due to incorrect outer packaging. Affected units have specific serial numbers and Australian configuration codes. No action is required as the packaging error does not affect safety.
Device packaged in incorrect outer box carton.
Abiomed is recalling certain Impella 5.5 with SmartAssist S2 devices because they were packaged in the wrong outer carton. This packaging issue does not pose a safety risk to users and requires no action.
The device was packaged in an incorrect outer carton, but this packaging issue does not affect the device's safety or function. The error is a labeling or shipping mistake that does not cause harm to users.
Healthcare professionals using the Impella 5.5 with SmartAssist S2 devices in Australia. Patients using these devices are not at risk due to the packaging error.
Check for serial numbers 621448-621455 on the device packaging. The Australian Configuration Code 1000770 and GTIN 00813502012828 also identify affected units.
Verify the serial numbers on the device packaging to confirm if it is affected.
No action is required as the packaging error does not affect safety.
Serial numbers 621448 through 621455 are affected.
Yes, the device is safe to use as the packaging error does not impact its function or safety.
We’ve drafted a message you can send Abiomed to request your refund or repair — edit it as you like.
Subject: Recall Z-1030-2026 — Abiomed Abiomed Hello, I own a Abiomed that is covered by recall Z-1030-2026 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.
