FDA Medical Device Recalls (openFDA)
Maquet Cardiovascular, LLC: Ultima Activator II Reusable Drive Mechanism, part # C-UA-5001. Labeled REF UA-5001.
- Recall number
- Z-0887-2022
- Recalling firm
- Maquet Cardiovascular, LLC
- Product
- Ultima Activator II Reusable Drive Mechanism, part # C-UA-5001. Labeled REF UA-5001.
- Status
- Open, Classified
- Initiated
- 2022-02-09
- Posted
- not on file
- Terminated
- not on file
- Reason
- 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.
- 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
- 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.
- Lot, serial or model codes
- 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.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- DWS
- Firm FEI
- 2242352
- Firm city
- Wayne
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28