Home › Device types › MWS
Stabilizer, Heart
FDA product code MWS · Class 1 · Cardiovascular
69
Registered devices
1,023
Adverse events
17
Recalls
4
510(k) clearances
Devices with this code
OCTOPUS® — MEDTRONIC, INC.STABILIZER TIPS — SONTEC INSTRUMENTS, INC.Acrobat-i Positioner — MAQUET CARDIOVASCULAR LLCOCTOPUS® — MEDTRONIC, INC.Viper II Heart Stabilizer — KDL MEDICAL, INC.STARFISH® EVO — MEDTRONIC, INC.OCTOPUS® — MEDTRONIC, INC.Tentacles — SB-KAWASUMI LABORATORIES, INC.HEART STABILIZER FINGER ATTACHMENT — SONTEC INSTRUMENTS, INC.STABILIZER TIPS — SONTEC INSTRUMENTS, INC.TRIPOD Stabilizer- Lt Mtl Fastract +2cm — KDL MEDICAL, INC.Herc Flex Universal Stabilizer Arm — Terumo Cardiovascular Systems CorporationURCHIN™ — MEDTRONIC, INC.OCTOPUS® — MEDTRONIC, INC.SHAMROCKFLEX — Aesculap AGAcrobat V Stabilizer — MAQUET CARDIOVASCULAR LLCTRIPOD Heart Stabilizer Nylon Occ FsTrac — KDL MEDICAL, INC.Acrobat SUV Stabilizer — MAQUET CARDIOVASCULAR LLCHEARTLINE STABILIZER ARM CLAMP — SONTEC INSTRUMENTS, INC.Heartline Stabilizer Arm — SONTEC INSTRUMENTS, INC.Titan Flex 360 Stabilizer — Terumo Cardiovascular Systems CorporationURCHIN® — MEDTRONIC, INC.HEART STABILIZER FINGER ATTACHMENT — SONTEC INSTRUMENTS, INC.Acrobat-I Stabilizer — MAQUET CARDIOVASCULAR LLC
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. |
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