FDA-Device2013-10-09Class IIMISBRANDING

Maquet Ultima OPCAB System cardiac surgery blades recalled for mislabeling

LABEL MIX UPNationwide distribution

Contact Maquet about Ultima OPCAB blade mislabeling

Maquet Cardiovascular identified incorrect labeling on two lots of blades used in the Ultima OPCAB cardiac surgery system. Standard blades were labeled as deep blades, and deep blades were labeled as standard blades, which could lead to use of the wrong blade type during surgery. No injuries have been reported.

If you received Ultima OPCAB System Lot #25052176 or Lot #25052200, contact Maquet Cardiovascular immediately
Do not use affected blade lots until you verify the correct blade type with Maquet
Check your inventory against the affected lot numbers: OM-2003S (Lot #25052176) and OM-2001D (Lot #25052200)

Hazard

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.

Sold states

USA Nationwide Distribution in the states of: Florida, Maryland, New Jersey, New York and Texas.

Affected count

20 units (Lot 25052176); 12 units (Lot #25052200)

Manufactured in

45 Barbour Pond Dr, Wayne, NJ, United States

Products

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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0001-2014

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