Cardiac Assist recalls TandemHeart Kit TS62/A17 (serials 00142612-00142972) due to assembly error causing failure to prime, which may lead to inadequate circulatory support.
Failure to prime due to an assembly error
Cardiac Assist is recalling TandemHeart Kit TS62/A17 models with specific serial numbers because of an assembly error that can cause the pump to fail to prime. This could lead to inadequate circulatory support for patients using the device.
The assembly error can cause the pump to fail to prime, meaning it may not function properly to provide circulatory support. This could lead to inadequate blood flow and potential complications for patients relying on the device.
Patients using the TandemHeart Kit TS62/A17 for temporary circulatory support are affected. Those with the listed serial numbers are most at risk.
Check the serial numbers on the TandemHeart Kit TS62/A17: 00142612, 00142614, 00142657, 00142658, 00142659, 00142660, 00142661, 00142663, 00142937, 00142938, 00142941, 00142942, 00142970, 00142971, 00142972.
Verify if your TandemHeart Kit TS62/A17 has one of the listed serial numbers: 00142612, 00142614, 00142657, 00142658, 00142659, 00142660, 00142661, 00142663, 00142937, 00142938, 00142941, 00142942, 00142970, 00142971, 00142972.
The recalled model is TandemHeart Kit TS62/A17 with specific serial numbers listed in the recall notice.
An assembly error can cause the pump to fail to prime, which may lead to inadequate circulatory support for patients using the device.
Check the serial numbers on your TandemHeart Kit TS62/A17 to see if it is in the list of affected units. If it is, 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-1950-2020 — Cardiac Assist Cardiac Assist Hello, I own a Cardiac Assist that is covered by recall Z-1950-2020 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.
