Maquet Cardiovascular, LLC: Medical Device Recall in 2022 - (Recall #: Z-0887-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

Ultima Activator II Reusable Drive Mechanism, part # C-UA-5001. Labeled REF UA-5001.

Product Classification:

Class II

Date Initiated: February 9, 2022

Date Posted: April 13, 2022

Recall Number: Z-0887-2022

Event ID: 89744

Reason for Recall:

Potential for corrosion on the pins of the Ultima Activator II Reusable Drive Mechanism. Harms may include allergic reaction, metal toxicity, and other delayed responses.

Status: Ongoing

Product Quantity: 60

Code Information:

UDI# 00607567700901, Lots (3): 25153700, 25157489, 25158616. Please note affected lot numbers (25153700, 25157489, 25158616) appear on the device package only. If the packaging has been discarded, the affected devices can be identified by Device Component Lot number (200501), which is etched onto all 3 device components on side of handle and on underside above each pin.

Distribution Pattern:

Worldwide - United States (AL, AZ, CA, FL, IL, KY, LA, MO, MT, NM, OH, PA, TX, WI), Germany, Republic of Korea (South Korea), Russia, Thailand, United Arab Emirates.

Voluntary or Mandated:

Voluntary: Firm initiated