Abiomed recalls lmpella CP with Smart Assist Model 0048-0003 due to incorrect programming that may cause pump migration and injury during cardiogenic shock support.
This one pump shipped with incorrect pump programming, the initial production working version of the program. The pump would have immediately run at P9 for all selected P-levels, rather than a 10 second ramp up period. The pump may have migrated out of position and possibly caused injury. The positioning and suction alarms were also disabled.
Abiomed recalls a specific model of left heart support blood pump for cardiogenic shock. The pump shipped with incorrect programming that could cause it to move out of place and potentially cause injury.
The pump was programmed to run immediately at a high setting (P9) instead of gradually ramping up over 10 seconds. This could cause the pump to migrate out of position and disable critical alarms, increasing injury risk.
Patients using this specific blood pump model for cardiogenic shock support are affected. Those with the model number 0048-0003 are most at risk.
Check for the model number 0048-0003 on the pump. This product was sold with a unique identifier (UDI) starting with (01)00813502011371 and serial number 192148A.
Look for the model number 0048-0003 on the pump to confirm it is recalled.
Yes, the pump may migrate out of position due to incorrect programming, which could cause injury.
The official recall does not specify a remedy, so contact Abiomed directly for guidance.
Check for model number 0048-0003, UDI starting with (01)00813502011371, and serial number 192148A.
We’ve drafted a message you can send Abiomed to request your refund or repair — edit it as you like.
Subject: Recall Z-0345-2020 — Abiomed Abiomed Hello, I own a Abiomed that is covered by recall Z-0345-2020 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
