Maquet recalls ACROBAT V Vacuum Off-Pump System (Part C-OM-9100S) due to risk of unstable chest stabilization during surgery, potentially causing device release 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 the ACROBAT V Vacuum Off-Pump System (Part Number C-OM-9100S) because its Standard Blade might not securely attach to the Activator Drive. This could lead to unstable heart positioning during surgery, possibly causing the device to release or requiring surgery to be stopped.
The Standard Blade may not stay securely attached to the Activator Drive during surgery. If it becomes loose, the system might not stabilize the heart properly, which could cause the device to release from the patient or require the surgery to be stopped.
Surgical teams using the ACROBAT V Vacuum Off-Pump System for cardiac or chest procedures are most at risk. The affected product is used in operating rooms during heart and chest surgeries.
Check for the part number C-OM-9100S on the ACROBAT V Vacuum Off-Pump System. This component is used in cardiac and chest surgery procedures.
Verify that the Standard Blade securely latches onto the Activator Drive before use.
The recall states the Standard Blade may not securely latch, which could cause unstable heart positioning during surgery. It is not safe to use without checking the attachment.
The recall does not specify a remedy for this issue. Check if the blade securely latches before use.
The recalled product is the ACROBAT V Vacuum Off-Pump System with part number C-OM-9100S, used in cardiac and chest surgery.
We’ve drafted a message you can send Maquet to request your refund or repair — edit it as you like.
Subject: Recall Z-2273-2023 — Maquet Maquet Hello, I own a Maquet that is covered by recall Z-2273-2023 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.
