CLASS II ONGOING Device recall · Reported 13 Apr 2022 · FDA Enforcement Report

Ultima Activator II Reusable Drive Mechanism, part # C-ua recalled

Maquet Cardiovascular is recalling Ultima Activator II Reusable Drive Mechanism, part # C-ua-5001, distributed in 14 states. The recall was initiated on 9 Feb 2022 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI# 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.

Quantity recalled60

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-0887-2022
FDA event ID: 89744
Recalling firm: Maquet Cardiovascular, Wayne, NJ
Classification: Class II
Status: Ongoing
Recall initiated: 9 Feb 2022
FDA classified: 6 Apr 2022
Reported: 13 Apr 2022
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Foreign Material
Device type: Other Medical Devices

Timeline

9 Feb 2022	Recall initiated by company
6 Apr 2022	Classified by FDA	+56 days
13 Apr 2022	Published in enforcement report	+7 days

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

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.

Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.

Product as listed by the FDA

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

Where it was distributed

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.

Alabama Arizona California Florida Illinois Kentucky Louisiana Missouri Montana New Mexico Ohio Pennsylvania Texas Wisconsin

Questions about this recall

Why was it recalled?

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.

Which lots are affected?

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.

Where was it sold?

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.

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 26 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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