The device failed to pump due to an electrical test failure code #58 (power up vent test fail), maintenance code #3, and an autofill failure which has been associated to a patient death due to the failure of the device to initiate therapy.
The device failed to pump due to an electrical test failure code #58 (power up vent test fail), maintenance code #3, and an autofill failure which has been associated to a patient death due to the failure of the device to initiate therapy.
We break every recall down into plain English — this one’s still on our list. Until our write-up is ready, the official FDA hazard and remedy below have the full, accurate details.
We’ve drafted a message you can send Maquet Datascope Corp - Cardiac Assist Division to request your refund or repair — edit it as you like.
Subject: Recall Z-2736-2017 — Maquet Datascope Corp - Cardiac Assist Division Maquet Datascope Corp - Cardiac Assist Division rec Hello, I own a Maquet Datascope Corp - Cardiac Assist Division recalls CS 100i Intra-Aortic Balloon Pump that is covered by recall Z-2736-2017 from Maquet Datascope Corp - Cardiac Assist Division. 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.
