Maquet recalls Cardiosave Hybrid IABP devices with part number 0998-00-800-53 for potential therapy interruption at high altitudes above 3200 ft.
There is a potential for interruption and/or inability to start therapy to the patient prior to or during use of Cardiosave IABP for users who are at altitudes above 3200 Ft.
Maquet is recalling Cardiosave Hybrid IABP devices that may stop working properly for patients at elevations over 3,200 feet. This could lead to serious cardiac complications if the device fails during critical use.
The device may fail to start or maintain therapy when used at high altitudes above 3,200 feet. This could cause cardiac complications if the patient's condition requires continuous support during elevation changes.
Cardiac patients using Cardiosave Hybrid IABP devices at altitudes above 3,200 feet are most at risk. Patients with specific medical conditions requiring continuous cardiac support are particularly vulnerable.
Check for the part number 0998-00-800-53 on the device. The recall includes all units with serial numbers starting with 10607567108391.
Confirm if you use the device at elevations above 3,200 feet. If so, contact Maquet for guidance.
No, but if you use it at high altitudes, contact Maquet for specific instructions.
The part number is 0998-00-800-53. Check the device label for this number.
The recall record does not mention a fix or remedy.
We’ve drafted a message you can send Maquet to request your refund or repair — edit it as you like.
Subject: Recall Z-0099-2019 — Maquet Maquet Hello, I own a Maquet that is covered by recall Z-0099-2019 from Maquet. 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.
