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Tentacles NEO

SB-KAWASUMI LABORATORIES, INC. · Model MD-27320A · UDI-DI 04545499071699

MWS Prescription

510(k) clearances

1,023

Adverse events (6 deaths)

Recalls

Facilities

Description

This Product is a device used as a heart positioner particularly for Off-Pump CABG (Coronary Artery Bypass Grafting). Three (3) Suction Cups are attached to the surface of the heart by means of suction pressure applied to each one of them. Traction Tubes are pulled and clamped to the surgical drape by Forceps in order to fix the position of the heart.

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 the bottom of the can
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 the bottom of the can
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 the bottom of the can
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 bottom of the canister, a
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-year shelf life.
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-year shelf life.
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-year shelf life.
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 previously placed bypass gra
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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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.