Ultima OPCAB System — Class II medical device recall Z-0001-2014
Terminated recall by Maquet Cardiovascular, LLC, reported 2013-10-09, distributed nationwide. MAQUET has identified a potential issue with the ULTIMA OPCAB (part numbers OM-2003S & OM-2001D). Labeling for
| Recall number | Z-0001-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Maquet Cardiovascular, LLC, Wayne, NJ, United States |
| Recall initiated | 2013-09-20 |
| Classified | 2013-10-01 |
| Reported by FDA | 2013-10-09 |
| Terminated | 2014-06-10 |
| Distributed | Nationwide (US) |
| Reason classes | labeling |
| Lot numbers | 25052176, 25052200 |
| Model numbers | OM-2003S |
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.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0001-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.