FDA Medical Device Recalls (openFDA)
Maquet Cardiovascular, LLC: Acrobat-i Positioner. Model Number C-XP-5000Z
- Recall number
- Z-0484-2025
- Recalling firm
- Maquet Cardiovascular, LLC
- Product
- Acrobat-i Positioner. Model Number C-XP-5000Z
- Status
- Open, Classified
- Initiated
- 2024-10-16
- Posted
- 2024-11-18
- Terminated
- not on file
- Reason
- Deviations in the manufacturing process created a compromise in the sterile barrier, in which sterility cannot be assured during the duration of the product's 2-year shelf life.
- Root cause
- Process change control
- Action
- MAQUET Cardiovascular LLC / Getinge notified consignees via letter FedEx 2-Day Delivery on 10/16/2024. Customers were instructed to forward the notification to all users and notify customers if further distributed, examine inventory and return any affected inventory, and to complete and return the MEDICAL DEVICE REMOVAL - RESPONSE FORM.
- Quantity
- 14,338 units
- Distribution
- Nationwide distribution. International distribution to Albania, Algeria, Austria, Bahrain, Bangladesh, Belarus, Belgium, Bosnia and Herzegovina, Brunei Canada, Croatia, Czech Republic, Denmark, Finland, France and Belarus, Germany, Greece, Hong Kong, India, Indonesia, Italy, Japan, Lebanon, Luxembourg, Malaysia, Netherlands, Oman, Pakistan, Poland, Portugal, Slovenia, South Africa, Spain, Switzerland, the Republic of Korea (South Korea), Turkey, United Arab Emirates, United Kingdom.
- Lot, serial or model codes
- Model Number C-XP-5000Z. UDI-DI Number: 00607567500006. Batch Numbers: 3000272452, 3000289270, 3000293675, 3000340401, 3000382289, 3000282355, 3000287205, 3000290368, 3000306921, 3000308238, 3000307458, 3000318694, 3000282741, 3000290350, 3000306394, 3000334128, 3000355318, 3000362345, 3000278266, 3000343467, 3000353846, 3000346421, 3000360292, 3000364706, 3000317546, 3000272461, 3000343116, 3000360175, 3000360569, 3000355540, 3000380141, 3000378810, 3000334322, 3000363049, 3000311731, 3000306920, 3000365139, 3000273855, 3000300092, 3000276339, 3000347351, 3000347358, 3000352249, 3000397151, 3000368288, 3000293958, 3000288356, 3000286557, 3000402809, 3000392590, 3000340972.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- MWS
- 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