medical Class II Updated 2023-08-09

Maquet Cardiovascular, LLC recalls ACCESSRAIL Platform (Standard Blade) Part Number SB-1000, an

Recalled Product

ACCESSRAIL Platform (Standard Blade) Part Number SB-1000, and (Deep Blades) Part Number C-DB-1000. Component of a chest stabilization system for cardiac and chest surgery.


Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: UDI-DI: 00607567700215
View official government recall

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