Cardiac Surgery Device Blade May Fail to Latch Securely During Use
The ACROBAT SUV blade may not latch securely onto its activator drive during use. This could prevent heart stabilization during surgery, cause positioning loss, or release device components into the patient.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II classification. Risk-of-harm product where device failure during cardiac surgery could prevent heart stabilization and result in release of device components. No illnesses or injuries have been reported.
Plain-English summary
Maquet Cardiovascular, LLC is recalling 401 units of the ACROBAT SUV Vacuum Off-Pump System, Part Number C-OM-9000S, used as a component of chest stabilization systems in cardiac and chest surgery. The Standard Blade component may not securely latch onto the Activator Drive.
If the blade fails to latch securely during use, it may result in inability to stabilize and position the heart, loss of stabilization and positioning, release of a device component into the patient, and procedural delays or conversion to alternative surgical approaches.
The device has been distributed worldwide in the United States and the following countries: Bangladesh, Brazil, Chile, Colombia, Iran, Jordan, Malaysia, Mexico, Netherlands, Singapore, Sudan, Taiwan, Thailand, and United Arab Emirates. Healthcare providers using this device should contact Maquet Cardiovascular, LLC for instructions regarding device replacement or repair, and report any adverse events.
The recalled product
- Product
- ACROBAT SUV Vacuum Off-Pump System, Part Number C-OM-9000S. Component of a chest stabilization system for cardiac and chest surgery.
- Manufacturer
- Maquet Cardiovascular, LLC
- Affected units
- 401
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI-DI: 00607567700543
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 recalled by Maquet Cardiovascular, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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