Recall Z-0485-2025 ยท MWS Stabilizer, Heart
Maquet Cardiovascular, LLC
Acrobat SUV Vacuum Stabilizer System, ST. Model Number C-OM-9000Z
| Date | Nov 18, 2024 (initiated Oct 16, 2024) |
| Status | Open, Classified |
| 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 | 10,778 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, Luxembo |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.