Maquet recalls ACROBAT-i Vacuum Stabilizer System (Part C-OM-10000) due to potential stabilization failure during cardiac surgery, risking device displacement or procedural delays.
The Standard Blade may not securely latch onto the Activator Drive. This may result in the inability to stabilize and position or may result in the loss of stabilization and positioning of heart, release of device component into the patient, and/or a procedural delay and/or conversion.
Maquet is recalling a vacuum stabilizer system used in cardiac surgery because its blade may not securely attach to the activator drive. This could cause the device to lose stabilization, potentially releasing components into the patient or delaying surgery.
The Standard Blade may not securely latch onto the Activator Drive during surgery. If this happens, the device could lose stabilization, leading to potential release of components into the patient or requiring surgery to be delayed or converted.
Surgical teams using the ACROBAT-i Vacuum Stabilizer System (Part C-OM-10000) for cardiac or chest procedures are affected. Patients undergoing these surgeries are at risk if the device fails to stabilize properly.
Check for the part number C-OM-10000 on the ACROBAT-i Vacuum Stabilizer System. This component is used in cardiac and chest surgery procedures.
Inspect if the Standard Blade securely latches onto the Activator Drive before use.
The recall applies to the ACROBAT-i Vacuum Stabilizer System used in cardiac and chest surgery. If your surgery uses this specific part, it may be affected.
Look for the part number C-OM-10000 on the ACROBAT-i Vacuum Stabilizer System used in cardiac or chest procedures.
The recall does not specify a remedy, so contact Maquet directly for guidance on next steps.
We’ve drafted a message you can send Maquet to request your refund or repair — edit it as you like.
Subject: Recall Z-2274-2023 — Maquet Maquet Hello, I own a Maquet that is covered by recall Z-2274-2023 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.
