Titan Flex 360 Stabilizer
Catalogue number T401232U, listed by Terumo Cardiovascular Systems Corporation, United States, under Stabilizer, Heart. 9 manufacturers in China are registered for this product code.
9manufacturers in China registered for this device type
1catalogue number
3recalls 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 | Terumo Cardiovascular Systems Corporation, United States |
|---|---|
| FDA product code | MWS |
| Device type | Stabilizer, Heart |
| Device class | Class 1 |
| Regulation | 21 CFR 870.4500 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2021-03-18 |
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, manufacturing date |
| Packaging | 5 piece case of 5 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| T401232U | 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 |
| Acrobat-I Stabilizer | Maquet Cardiovascular LLC | 2 |
| 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 |
Showing 12 of 36. All products under Stabilizer, Heart
Recalls
3 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 |
|---|---|---|---|---|---|
| 2021-03-02 | Class II | Employee error | There is a potential for the stainless steel locking plates on the device’s sternal retractor locking mechanism to fracture. | 12 | 2021-11-05 |
| 2015-01-05 | Class II | Other | Terumo Cardiovascular Systems (Terumo CVS) is voluntarily recalling certain lots of Titan” Stabilizers and Titan” 360 Stabilizers because the Suction Tubing Clip may break when it is being attached to a Terumo CVS Hercules Stabilizing Arm. | 1463 | 2017-02-23 |
| 2014-08-20 | Class II | Device Design | Terumo Cardiovascular Systems (Terumo CVS) is recalling certain lots of Hercules TM 360 Universal Stabilizing Arms because the two pins that hold the sleeve attached to the distal end of the device may come loose, causing the pins and sleev | The total number of distributed devices stands at 260 | 2017-02-15 |
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.