The Recall Desk
HighFDA (Devices)·Z-2274-2023·Announced 2023-08-09

ACROBAT-i Vacuum Stabilizer Blade Latching Failure in Cardiac Surgery Systems

A latching mechanism in the ACROBAT-i Vacuum Stabilizer System may fail during cardiac surgery, potentially causing loss of heart stabilization or device component release. The defect affects 334 units distributed worldwide.

What this means for you

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: This FDA Class II medical device recall involves a failure mechanism that could result in loss of cardiac stabilization and device component release into the patient during surgery. No hospitalizations or injuries have been reported, making this a risk-of-harm product where injury has not yet been reported, consistent with a High severity classification.

Plain-English summary

The ACROBAT-i Vacuum Stabilizer System, Part Number C-OM-10000, manufactured by Maquet Cardiovascular, LLC, is used as a component of chest stabilization systems during cardiac and chest surgery.

The Standard Blade may not securely latch onto the Activator Drive. If this occurs during surgery, it may prevent stabilization and positioning of the heart, result in loss of stabilization and positioning, cause a device component to be released into the patient, or result in procedural delay or conversion to an alternative surgical approach.

The recall affects 334 units that have been distributed worldwide, including throughout the United States and to Bangladesh, Brazil, Chile, Colombia, Iran, Jordan, Malaysia, Mexico, Netherlands, Singapore, Sudan, Taiwan, Thailand, and the United Arab Emirates.

Healthcare facilities using this device should verify their inventory against the affected UDI-DI (00607567700581) and consult FDA guidance and manufacturer instructions regarding corrective actions.

The recalled product

Product
ACROBAT-i Vacuum Stabilizer System, Part Number C-OM-10000. Component of a chest stabilization system for cardiac and chest surgery.
Manufacturer
Maquet Cardiovascular, LLC
Category
Medical Device — Cardiac Surgery Equipment
Hazard
  • latching-failure
  • loss-of-stabilization
  • device-release
  • procedural-delay

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: 00607567700581

Distribution

Distributed nationwide across the United States.

Related recalls

Same category