Device 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.
Z-0001-2014
Product summary
- Event
- Event 66365
- Status
- Terminated
- Classification
- Class II
- Quantity
- 20 units (Lot 25052176); 12 units (Lot #25052200)
- Official record key
device-enforcement:Z-0001-2014
Official wording
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.
Code information: ULTIMA OPCAB System Part Nos. OM-2003S (LOT #25052176) and OM-2001D (LOT #25052200).
Distribution pattern: USA Nationwide Distribution in the states of: Florida, Maryland, New Jersey, New York and Texas.
Derived failure modes
-
Labeling or packaging
incorrectly labeled