Cardiac Assist recalls specific TandemHeart ProtekDuo Kit models (DL29) due to assembly error causing failure to prime, potentially leading to inadequate circulatory support.
Failure to prime due to an assembly error
Cardiac Assist is recalling specific TandemHeart ProtekDuo Kit models (DL29) because an assembly error may cause the pump to fail to prime. This could lead to inadequate circulatory support during temporary extracorporeal circulation. Affected units have specific serial numbers listed in the recall notice.
An assembly error in the kit can cause the pump to fail to prime properly. This means the device may not function correctly to provide temporary circulatory support, potentially leading to inadequate blood flow.
Patients using the TandemHeart ProtekDuo Kit (DL29) for temporary circulatory support are most at risk. The recall affects specific units with the listed serial numbers.
Check if your TandemHeart ProtekDuo Kit (DL29) has a serial number from the list provided in the recall notice. The affected units have specific serial numbers starting with 00142569 through 00142936.
Verify your kit's serial number against the list of affected units provided in the recall notice.
The TandemHeart ProtekDuo Kit (DL29) with product number 5720-2916.
An assembly error may cause the pump to fail to prime, potentially leading to inadequate circulatory support.
Check your serial number against the list of affected units provided in the recall notice. If affected, contact Cardiac Assist for further instructions.
We’ve drafted a message you can send Cardiac Assist to request your refund or repair — edit it as you like.
Subject: Recall Z-1951-2020 — Cardiac Assist Cardiac Assist Hello, I own a Cardiac Assist that is covered by recall Z-1951-2020 from Cardiac Assist. 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.
