Z-0486-2025Class II

Acrobat-i Vacuum Stabilizer System. Model Number C-OM-10000Z

Name: Z-0486-2025 Acrobat-i Vacuum Stabilizer System. Model Number C-OM-10000Z
Creator: Maquet Cardiovascular, LLC
Published: 2024-10-16
License: https://open.fda.gov/license/

Maquet Cardiovascular LLC / initiated 2024-10-16 / Open, Classified / root cause: packaging

FDA source

Maquet Cardiovascular, LLC began a recall of Acrobat-i Vacuum Stabilizer System. Model Number C-OM-10000Z on 2024-10-16. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0486-2025
Classification: Class II
Status: Open, Classified
Initiated: 2024-10-16
Posted: 2024-11-18
Recalling firm: Maquet Cardiovascular LLC
Product: Acrobat-i Vacuum Stabilizer System. Model Number C-OM-10000Z
Product code: MWS Stabilizer, Heart
Reason for recall: 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 tag: packaging
FDA 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 in commerce: 33,823 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.
Product codes and lots: Model Number C-OM-10000Z. UDI-DI Number: 00607567100008. Batch Numbers: 3000277221, 3000286549, 3000315868, 3000317517, 3000322538, 3000339447, 3000363028, 3000270713, 3000275435, 3000275771, 3000280868, 3000284390, 3000303149, 3000321642, 3000342528, 3000336070, 3000322179, 3000337396, 3000273182, 3000282181, 3000337880, 3000353535, 3000364172, 3000357109, 3000276109, 3000338107, 3000354445, 3000355050, 3000352899, 3000324785, 3000360894, 3000370720, 3000323627, 3000346330, 3000356740, 3000278665, 3000344012, 3000366729, 3000361801, 3000400928, 3000363775, 3000311956, 3000343553, 3000367559, 3000377818, 3000341430, 3000367345, 3000336377, 3000316208, 3000381449, 3000380956, 3000403756, 3000321414, 3000361499, 3000407809, 3000398030, 3000387678, 3000320077, 3000277072, 3000283754, 3000296552, 3000320660, 3000339096, 3000347694, 3000348390, 3000352250, 3000279303, 3000277309, 3000282794, 3000283482, 3000350599, 3000351774, 3000351996, 3000365741, 3000369223, 3000369738, 3000393258, 3000323129, 3000273547, 3000366133, 3000391146, 3000273843, 3000280827, 3000295912, 3000346410, 3000401855, 3000384033, 3000382967, 3000378703, 3000363755, 3000316146, 3000295949, 3000398861, 3000394893, 3000380542, 3000361797, 3000350598, 3000320073, 3000299042, 3000295186, 3000288696, 3000284723, 3000274876, 3000363227, 3000285664.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0486-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0484-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-11-27	2024-11-18
Z-0485-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-11-27	2024-11-18
Z-0486-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-11-27	2024-11-18

Product code MWS

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)