CLASS II Device recall · Reported 9 Oct 2013 · FDA Enforcement Report

Ultima Opcab System, Sterile recalled by Maquet Cardiovascular

Maquet Cardiovascular is recalling Ultima Opcab System, Sterile, distributed nationwide in the US. The recall was initiated on 20 Sep 2013 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesULTIMA OPCAB System Part Nos. OM-2003S (LOT #25052176) and OM-2001D (LOT #25052200).

Quantity recalled20 units (Lot 25052176); 12 units (Lot #25052200)

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0001-2014
FDA event ID: 66365
Recalling firm: Maquet Cardiovascular, Wayne, NJ
Classification: Class II
Status: Terminated
Recall initiated: 20 Sep 2013
FDA classified: 1 Oct 2013
Reported: 9 Oct 2013
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Labeling Errors
Device type: Surgical Instruments

Timeline

20 Sep 2013	Recall initiated by company
1 Oct 2013	Classified by FDA	+11 days
9 Oct 2013	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

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.

Where it was distributed

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

Nationwide Florida Maryland New Jersey New York Texas

Stores named: Target

Questions about this recall

Is Ultima Opcab System, Sterile recalled?

Yes. Maquet Cardiovascular recalled Ultima Opcab System, Sterile on 20 Sep 2013. The recall is Class II and its status is Terminated. Recall number Z-0001-2014.

Why was it recalled?

Which lots are affected?

ULTIMA OPCAB System Part Nos. OM-2003S (LOT #25052176) and OM-2001D (LOT #25052200).

Where was it sold?

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

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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