Maquet recalls Cardiohelp-i Transport Guard (serials 90413945-90414319) due to potential loose pin causing jamming or disassembly, delaying critical medical support.
Potential for a loose cylindrical pin on the Transport Guard that may result in the jamming of the locking mechanism causing the Transport Guard to not open or, if the locking pin is fully disengaged from the assembly, a full disassembly of the Transport Guard may occur, resulting in a delay of support if a product exchange is necessary.
Maquet is recalling specific Cardiohelp-i Transport Guards that may have a loose pin causing the device to jam or disassemble. This could delay critical medical support during emergencies if a product exchange is needed.
A loose cylindrical pin can jam the locking mechanism, preventing the Transport Guard from opening. If the pin fully disengages, the entire device may disassemble, potentially delaying critical medical support if a product exchange is necessary.
Healthcare professionals using the Cardiohelp-i Transport Guard for blood oxygenation and carbon dioxide removal during surgeries. Patients receiving this device are at risk if the device malfunctions during critical procedures.
The Cardiohelp-i Transport Guard (model 701072525) with serial numbers starting with 90413945 through 90414319. This device is used with Cardiohelp-i blood oxygenation systems for cardiac surgery.
Look for the serial number on the device packaging or label, which should start with 90413945 through 90414319.
If you have the recalled device, contact Maquet Medical Systems USA for instructions on potential fixes or exchanges.
It's a blood oxygenation and carbon dioxide removal system used during cardiac surgery to pump blood through the extracorporeal bypass circuit for up to six hours.
The recalled model has serial numbers starting with 90413945 through 90414319, as listed in the product description.
The recall record does not specify a remedy, so contact Maquet Medical Systems USA directly for instructions.
We’ve drafted a message you can send Maquet Medical Systems to request your refund or repair — edit it as you like.
Subject: Recall Z-0897-2022 — Maquet Medical Systems Maquet Medical Systems Hello, I own a Maquet Medical Systems that is covered by recall Z-0897-2022 from Maquet Medical Systems. 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.
