Agency classClass IIOur severity:High FDA (Devices)·Z-0887-2022·Announced 2022-04-13

Surgical drive mechanism recalled due to corrosion risk

Maquet Cardiovascular is recalling the Ultima Activator II Reusable Drive Mechanism due to potential corrosion on pins, which could cause allergic reactions, metal toxicity, and other delayed health effects.

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: This is an FDA Class II recall involving a surgical device with potential for corrosion that could cause metal toxicity and allergic reactions. No reported illnesses or injuries have been documented; the hazard is theoretical. Per the severity rubric, recalls involving risk-of-harm products where injury has not yet been reported receive a High (3) severity score.

Plain-English summary

Maquet Cardiovascular, LLC is recalling the Ultima Activator II Reusable Drive Mechanism (part number C-UA-5001, labeled REF UA-5001). The recall affects 60 units with lot numbers 25153700, 25157489, and 25158616.

The device has the potential for corrosion on its pins. This corrosion could result in exposure to corroded metal, leading to possible allergic reactions, metal toxicity, and other delayed health responses.

The recalled devices have been distributed worldwide, including in the United States (Alabama, Arizona, California, Florida, Illinois, Kentucky, Louisiana, Missouri, Montana, New Mexico, Ohio, Pennsylvania, Texas, and Wisconsin), Germany, South Korea, Russia, Thailand, and the United Arab Emirates.

Affected devices can be identified by the UDI (00607567700901) and lot numbers on the package. If packaging has been discarded, the device component lot number (200501) is etched onto all three device components on the side of the handle and on the underside above each pin. Healthcare facilities and users in possession of affected units should contact Maquet Cardiovascular for replacement or return instructions.

The recalled product

Product: Ultima Activator II Reusable Drive Mechanism, part # C-UA-5001. Labeled REF UA-5001.
Manufacturer: Maquet Cardiovascular, LLC
Category: Medical Device — Surgical / Cardiac Device
Hazard: corrosion
metal-toxicity
allergic-reaction
Affected units: 60

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (5)

UDI# 00607567700901
Lots (3): 25153700
25157489
25158616. Please note affected lot numbers (25153700
the affected devices can be identified by Device Component Lot number (200501)

Distribution

Distributed in 14 states:

Same manufacturer · Maquet Cardiovascular, LLC

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Same hazard · corrosion