Maquet recalls ACROBAT SUV Vacuum Off-Pump System (part C-OM-90:000S) due to potential instability during cardiac surgery, risking device failure and patient safety.
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 specific vacuum system used in cardiac surgery because its blade might not stay securely attached to the device. This could lead to the system failing during surgery, potentially causing harm to the patient.
The system's blade may not securely latch onto the device's activator drive during surgery. If this happens, the system might not stabilize the heart properly, or it could release parts into the patient's body, causing delays or needing to switch to a different procedure.
Surgical teams using the ACROBAT SUV Vacuum Off-Pump System for cardiac procedures are most at risk. Patients undergoing heart or chest surgery with this device may be affected.
Check for the part number C-OM-9000S on the ACROBAT SUV Vacuum Off-Pump System used in cardiac and chest surgery. The device has a unique identifier (UDI-DI: 00607567700543).
Verify if the blade securely latches onto the activator drive before use.
The device may not be safe to use as it could fail during surgery, risking patient safety. The manufacturer recommends checking the blade's secure attachment.
The recall does not specify a remedy, so users should check the blade's secure attachment before use and contact the manufacturer if concerns arise.
Look for the part number C-OM-9000S on the ACROBAT SUV Vacuum Off-Pump System used in cardiac and chest surgery. The unique identifier is UDI-DI: 00607567700543.
We’ve drafted a message you can send Maquet to request your refund or repair — edit it as you like.
Subject: Recall Z-2272-2023 — Maquet Maquet Hello, I own a Maquet that is covered by recall Z-2272-2023 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.