Recall Z-0001-2014— Maquet Cardiovascular, LLC

Class II FDA medical device recall by Maquet Cardiovascular, LLC, initiated 2013-09-20, terminated 2014-06-10. FDA's recall record names no specific 510(k) clearance for this event. Product: Ultima OPCAB System, Sterile, Rx Only, Product Usage: Intended for use during performance of minimally invasive cardiac surgery through a sternotomy incision approach. The ULTIMA Access RailPlatform in combination with the Activator II Drive Mechanism is used to spread the sternum, providing access and direct visualization to the thoracic cavity. The AccessRail Platform also allows for the organization of pericardial sutures. The ULTIMA Stablizer isolates and provides local immobilization of the target vessel on the beating heart.. Reason: MAQUET has identified a potential issue with the ULTIMA OPCAB (part numbers OM-2003S & OM-2001D). Labeling for the 2 blade lots had been incorrectly applied. The standard blades from Lot #25052176 were incorrectly labeled as deep blades, and the 20 deep blades from Lot #25052200 were incorrectly labeled as standard blades..

Recalling firm

Maquet Cardiovascular, LLC

Classification

Class II

Status

Terminated

Initiated

2013-09-20

Terminated

2014-06-10

Firm location

Wayne, NJ, United States

Data sourced from openFDA. This site is unofficial and independent of the FDA.