Maquet Cardiovascular, LLC: Medical Device Recall in 2013 - (Recall #: Z-0001-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: September 20, 2013

Date Posted: October 9, 2013

Recall Number: Z-0001-2014

Event ID: 66365

Reason for Recall:

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.

Status: Terminated

Product Quantity: 20 units (Lot 25052176); 12 units (Lot #25052200)

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.

Voluntary or Mandated:

Voluntary: Firm initiated