Z-0001-2014Class II

Ultima OPCAB System, Sterile, Rx Only

Name: Z-0001-2014 Ultima OPCAB System, Sterile, Rx Only
Creator: Maquet Cardiovascular, LLC
Published: 2013-09-20
License: https://open.fda.gov/license/

Maquet Cardiovascular LLC / initiated 2013-09-20 / Terminated / root cause: labeling and UDI

FDA source

Maquet Cardiovascular, LLC began a recall of Ultima OPCAB System, Sterile, Rx Only, Product Usage: Intended for use during performance of minimally invasive cardiac surgery through a sternotomy incision... on 2013-09-20. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0001-2014
Classification: Class II
Status: Terminated
Initiated: 2013-09-20
Posted: 2013-10-01
Terminated: 2014-06-10
Recalling firm: Maquet Cardiovascular LLC
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.
Product code: OFA Cardiovascular Surgical Instruments Tray
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.
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
Action: MAQUET sent an "Urgent Medical Device Recall" letter and "Field Recall Response Forms" dated September 20, 2013 to customers via Federal Express. The notification identifies the affected product; informs the customers of the nature of the issue; and advises of potential adverse patient consequences that may occur. The customer is asked to complete and return the Field Recall Response Form. If the customer has questions they are directed to contact their field representative or MAQUET Technical Support (888.627.8383 between 8 am and 5 pm EST Monday through Friday).
Quantity in commerce: 20 units (Lot 25052176); 12 units (Lot #25052200)
Distribution: USA Nationwide Distribution in the states of: Florida, Maryland, New Jersey, New York and Texas.
Product codes and lots: ULTIMA OPCAB System Part Nos. OM-2003S (LOT #25052176) and OM-2001D (LOT #25052200).

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0001-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0001-2014	Class II	Terminated	Voluntary: Firm initiated	2013-10-09	2013-10-01

Product code OFA

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)