Agency classClass IIOur severity:High FDA (Devices)·Z-0001-2014·Announced 2013-10-09

Maquet Recalls Ultima OPCAB Systems Due to Incorrect Blade Labeling

Maquet Cardiovascular is recalling specific lots of Ultima OPCAB Systems because standard and deep blades were incorrectly labeled, posing a risk during cardiac surgery.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a high-risk medical device where incorrect labeling could lead to the use of the wrong surgical instrument, representing a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Maquet Cardiovascular, LLC is recalling specific lots of the Ultima OPCAB System, a sterile, prescription-only medical device intended for use during minimally invasive cardiac surgery. The recall involves 20 units from Lot #25052176 (Part No. OM-2003S) and 12 units from Lot #25052200 (Part No. OM-2001D). These units were distributed nationwide in Florida, Maryland, New Jersey, New York, and Texas.

The recall was initiated because the labeling for the two blade lots was incorrectly applied. Specifically, the standard blades from Lot #25052176 were incorrectly labeled as deep blades, while the 20 deep blades from Lot #25052200 were incorrectly labeled as standard blades. This mislabeling could lead to the use of the wrong blade type during surgical procedures.

Healthcare facilities and consumers who have these specific units should stop using them immediately and contact Maquet Cardiovascular for instructions on return or replacement. The device is intended to spread the sternum and provide access to the thoracic cavity during surgery, making accurate component identification critical for patient safety.

The recalled product

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…
Manufacturer: Maquet Cardiovascular, LLC
Category: Medical Device — Surgical Instruments
Hazard: mis-labeling
surgical-error

Distribution

Distributed nationwide across the United States.

The notice also names 5 states specifically:

Same manufacturer · Maquet Cardiovascular, LLC

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Same hazard · mis labeling