The Recall Desk
HighFDA (Devices)·Z-2273-2023·Announced 2023-08-09

ACROBAT V Cardiac Stabilization System may fail to secure during surgery

A latch defect in the ACROBAT V Vacuum Off-Pump System may prevent proper heart stabilization during cardiac surgery. Maquet Cardiovascular recalled 594 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: FDA Class II medical device with significant risk of patient harm during cardiac surgery (loss of stabilization, potential device component release into patient), but no reported injuries or hospitalizations in the source text. This meets the rubric criterion for risk-of-harm products where injury has not yet been reported.

Plain-English summary

The ACROBAT V Vacuum Off-Pump System is a component used in cardiac and chest surgery to stabilize and position the heart. Maquet Cardiovascular has recalled 594 units (UDI-DI: 00607567700536) due to a defect in the Standard Blade component.

The Standard Blade may not securely latch onto the Activator Drive. During surgery, this could result in the inability to stabilize and position the heart, loss of device stabilization, release of the device component into the patient, or an unexpected conversion from off-pump to open-heart surgery.

The affected units were distributed worldwide, including throughout the United States and to hospitals in Bangladesh, Brazil, Chile, Colombia, Iran, Jordan, Malaysia, Mexico, Netherlands, Singapore, Sudan, Taiwan, Thailand, and the United Arab Emirates.

Healthcare facilities using this equipment should inspect the Standard Blade for proper latching and contact Maquet Cardiovascular with any questions. Anyone who has experienced problems with this device should report the issue to the FDA.

The recalled product

Product
ACROBAT V Vacuum Off-Pump System, Part Number C-OM-9100S. Component of a chest stabilization system for cardiac and chest surgery.
Manufacturer
Maquet Cardiovascular, LLC
Category
Medical Device — Cardiac surgery stabilization
Hazard
  • mechanical-failure
  • loss-of-stabilization
  • component-release

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: 00607567700536

Distribution

Distributed nationwide across the United States.

Related recalls

Same category