Acrobat-I Stabilizer
Acrobat-i Vacuum Stabilizer System
9manufacturers in China registered for this device type
2catalogue numbers in this listing
8recalls on this code
Who Else Makes It
Concentrated in Guangdong (3), Beijing (3), Jiangsu (2). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Jiangsu Guangda Medical Material Group Co., Ltd. | Haian | Jiangsu | Contract manufacturer | 32 |
| Modern Medical Equipment Manufacturing Ltd. | Heng Li, Dongguan | Guangdong | Contract manufacturer | 26 |
| Maquet (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 6 |
| Modern Medical Equipment Manufacturing (Qing Yuan) Ltd | Qing Yuan | Guangdong | Contract manufacturer | 26 |
| Bothwin (Beijing) Medical Technology Co., Ltd. | Beijng | Beijing | Manufacturer | 25 |
| Global Medical Production Co., Ltd. | Jiaxing | Zhejiang | Manufacturer | 10 |
| Beijing Hangtian Kadi Technology R&D Institute | Beijing | Beijing | Manufacturer | 5 |
| Sumitomo Bakelite (Dongguan) Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 3 |
| Beijing Yuewei Medical Technology Co., Ltd. | Beijing | Beijing | Manufacturer | 2 |
Record
| Listed by | Maquet Cardiovascular LLC, United States |
|---|---|
| FDA product code | MWS |
| Device type | Stabilizer, Heart |
| Device class | Class 1 |
| Regulation | 21 CFR 870.4500 |
| Establishment | Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2016-09-24 |
| Record revised | 2021-04-09 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| OM-10000 | In distribution | |
| OM-10000Z | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Octopus® | Medtronic, Inc. | 11 |
| Heart Stabilizer Finger Attachment | Sontec Instruments, Inc. | 6 |
| Heartline Stabilizer Arm | Sontec Instruments, Inc. | 6 |
| Starfish™ | Medtronic, Inc. | 4 |
| Stabilizer Tips | Sontec Instruments, Inc. | 4 |
| Urchin® | Medtronic, Inc. | 3 |
| Viper II Heart Stabilizer | KDL Medical, Inc. | 2 |
| Viper II Apical Lift | KDL Medical, Inc. | 2 |
| Acrobat-i Positioner | Maquet Cardiovascular LLC | 2 |
| Acrobat SUV Stabilizer | Maquet Cardiovascular LLC | 2 |
| Starfish® EVO | Medtronic, Inc. | 2 |
| Heartline Stabilizer ARM Clamp | Sontec Instruments, Inc. | 1 |
Showing 12 of 36. All products under Stabilizer, Heart
Recalls Naming This Product
3 recalls name this product by its own identifiers, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Maquet Cardiovascular LLC | UDI-DI | 2024-10-16 | Class II | Process change control | 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. | 33,823 units |
| Maquet Cardiovascular LLC | UDI-DI | 2023-09-13 | Class II | Device Design | Housing Mount Jaw of these devices breaking during normal use and may result in injury to the epicardial tissue or vasculature, or a coronary artery or previously placed bypass graft, or could result in procedural delay and/or conversion. | 2951 units |
| Maquet Cardiovascular LLC | UDI-DI | 2023-06-28 | Class II | Nonconforming Material/Component | The Standard Blade may not securely latch onto the Activator Drive. This may result in the inability to stabilize and position or may result in the loss of stabilization and positioning of heart, release of device component into the patient | 334 units |
Recalls
4 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2024-10-16 | Class II | Process change control | 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. | 10,778 units | |
| 2024-10-16 | Class II | Process change control | 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. | 14,338 units | |
| 2023-10-31 | Class II | Component design/selection | The Positioner Arm may not tighten or lock during normal use. | 6472 units | |
| 2014-08-13 | Class II | Package design/selection | An internal finding identified the presence of pinholes/cuts in some of the Tyvek pouches of the vacuum tubing sets included as an accessory to Acrobat V Vacuum Off-Pump System, Acrobat SUV Vacuum Off-Pump System, Axius XPOSE 3 Access Devic | 16,532 units (19,270 units international) | 2016-03-30 |
| 2011-11-16 | Not classified | Employee error | There may be a small perforation in the sterile pouch of select lots of the ACROBAT V, ACROBAT SUV, and ACROBAT Mechanical Stabilizers and the XPOSE 3 and XPOSE 4 Positioners. | 9436 unit total (US AND WORLDWIDE) | 2014-01-10 |
| 2011-11-16 | Not classified | Employee error | There may be a small perforation in the sterile pouch of select lots of the ACROBAT V, ACROBAT SUV, and ACROBAT Mechanical Stabilizers and the XPOSE 3 and XPOSE 4 Positioners. | 9436 unit total (US AND WORLDWIDE) | 2014-01-10 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.