Home › Device types › MWS
Stabilizer, Heart
FDA product code MWS · Class 1 · Cardiovascular
71
Registered devices
1,034
Adverse events
17
Recalls
4
510(k) clearances
Devices with this code
Viper II Apical Lift — KDL Medical, Inc.Heartline Stabilizer Arm — SONTEC INSTRUMENTS, INC.STARFISH® EVO — MEDTRONIC, INC.STABILIZER TIPS — SONTEC INSTRUMENTS, INC.HEARTLINE STABILIZER ARM — SONTEC INSTRUMENTS, INC.STARFISH™ — MEDTRONIC, INC.Heartline Stabilizer Arm — SONTEC INSTRUMENTS, INC.Acrobat-i Positioner — MAQUET CARDIOVASCULAR LLCMedline — MEDLINE INDUSTRIES, INC.OCTOPUS® — MEDTRONIC, INC.Heartline Stabilizer Arm — SONTEC INSTRUMENTS, INC.Viper II Heart Stabilizer — KDL Medical, Inc.URCHIN™ — MEDTRONIC, INC.URCHIN® — MEDTRONIC, INC.STARFISH™ — MEDTRONIC, INC.Stabilizer Clamp — KOROS U.S.A., INC.Acrobat-I Stabilizer — MAQUET CARDIOVASCULAR LLCOCTOPUS® — MEDTRONIC, INC.URCHIN® — MEDTRONIC, INC.Starfish™ Evo — MEDTRONIC, INC.OCTOPUS® — MEDTRONIC, INC.Viper I Heart Stabilizer — KDL Medical, Inc.HEART STABILIZER FINGER ATTACHMENT — SONTEC INSTRUMENTS, INC.OCTOPUS® — MEDTRONIC, INC.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-05-12 | Medtronic Perfusion Systems | During the manufacturing process, Medtronic personnel identified an assembly issue where the tubing was incorrectly positioned. The short tube was attached to t |
| 2026-05-12 | Medtronic Perfusion Systems | During the manufacturing process, Medtronic personnel identified an assembly issue where the tubing was incorrectly positioned. The short tube was attached to t |
| 2026-05-12 | Medtronic Perfusion Systems | During the manufacturing process, Medtronic personnel identified an assembly issue where the tubing was incorrectly positioned. The short tube was attached to t |
| 2026-01-13 | Medtronic Perfusion Systems | During the manufacturing, Medtronic personnel identified an assembly issue where the tubing was incorrectly positioned. The short tube was attached to the botto |
| 2024-10-16 | Maquet Cardiovascular, LLC | 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 |
| 2024-10-16 | Maquet Cardiovascular, LLC | 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 |
| 2024-10-16 | Maquet Cardiovascular, LLC | 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 |
| 2023-10-31 | Maquet Cardiovascular, LLC | The Positioner Arm may not tighten or lock during normal use. |
| 2023-09-13 | Maquet Cardiovascular, LLC | 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 previous |
| 2021-03-02 | Terumo Cardiovascular Systems Corporation | There is a potential for the stainless steel locking plates on the device's sternal retractor locking mechanism to fracture. |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsSourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.