Maquet recalls Cardiosave Rescue IABP pumps with part number 0998-UC-0800-83 for potential therapy interruption at altitudes above 3200 feet.
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 Rescue IABP blood pumps that may stop working properly when used at elevations over 3,200 feet. This could prevent life-saving treatment for patients in high-altitude settings.
The pump may fail to start or maintain therapy when used at elevations above 3,200 feet due to atmospheric pressure changes. This could lead to interrupted treatment for patients needing cardiac support.
Patients using Cardiosave Rescue IABP pumps at altitudes above 3,200 feet are most at risk. This includes users in mountainous areas or high-altitude medical facilities.
Check for part number 0998-UC-0800-83 on the pump. The unique device identifier (UDI) is 10607567108407. This recall covers all units sold with these identifiers.
If you use this pump at elevations above 3,200 feet, contact your healthcare provider immediately.
No, but you should check with your healthcare provider if you use this pump at elevations above 3,200 feet.
Look for part number 0998-UC-0800-83 on the pump.
The recall does not provide a fix; you must consult your healthcare provider for altitude-specific use.
We’ve drafted a message you can send Maquet to request your refund or repair — edit it as you like.
Subject: Recall Z-0100-2019 — Maquet Maquet Hello, I own a Maquet that is covered by recall Z-0100-2019 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.