Z-0887-2022Class II

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

Name: Z-0887-2022 Ultima Activator II Reusable Drive Mechanism, part # C-UA-5001. Labeled REF UA-5001
Creator: Maquet Cardiovascular, LLC
Published: 2022-02-09
License: https://open.fda.gov/license/

Maquet Cardiovascular LLC / initiated 2022-02-09 / Open, Classified

FDA source

Maquet Cardiovascular, LLC began a recall of Ultima Activator II Reusable Drive Mechanism, part # C-UA-5001. Labeled REF UA-5001 on 2022-02-09. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-0887-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-02-09
Posted: 2022-04-12
Recalling firm: Maquet Cardiovascular LLC
Product: Ultima Activator II Reusable Drive Mechanism, part # C-UA-5001. Labeled REF UA-5001.
Product code: DWS Instruments, Surgical, Cardiovascular
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.
FDA root cause: Mixed-up of materials/components
Action: On February 14, 2022, a customer notification letter was issued via FedEx. Customers are instructed to quarantine and return all affected product and notify all users within the hospital/facility. Please note affected lot numbers appear on the device package only. If the packaging has been discarded, the affected devices can be identified by Device Component Lot number, which is etched onto all 3 device components on side of handle and on underside above each pin. Customers are to complete and return the response form by email or fax. Distributors are to forward this document to customers for appropriate action. If you have any questions, please contact your Maquet Cardiovascular, LLC /Getinge representative or call the Getinge Customer Service at (888) 880-2874, Monday through Friday, between the hours of 6:00a.m. and 5:00 p.m. (Pacific Standard Time)
Quantity in commerce: 60
Distribution: 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.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0887-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0887-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-04-13	2022-04-06

Product code DWS

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)