Stabilizer, Heart

Reports per year

Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.

Recent recalls

• 2026-06-24Open, ClassifiedUnder Investigation by firm

  Octopus Evolution Tissue Stabilizer, Model TS2000

  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 canister, and the long tube was attached to the top, contrary to the intended design.

• 2026-06-24Open, ClassifiedUnder Investigation by firm

  Octopus Evolution AS Tissue Stabilizer, Model TS2500

  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 canister, and the long tube was attached to the top, contrary to the intended design.

• 2026-06-24Open, ClassifiedUnder Investigation by firm

  Octopus 4 Tissue Stabilizer, Model 29400

  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 canister, and the long tube was attached to the top, contrary to the intended design.

• 2026-02-26Open, ClassifiedUnder Investigation by firm

  Octopus Nuvo Tissue Stabilizer, disposable tissue stabilization system, Product Number TSMICS1

  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, and the long tube was attached to the top, contrary to the intended design.

• 2024-11-18Open, ClassifiedProcess change control

  Acrobat-i Positioner. Model Number C-XP-5000Z

  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.

• 2024-11-18Open, ClassifiedProcess change control

  Acrobat SUV Vacuum Stabilizer System, ST. Model Number C-OM-9000Z

  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.

• 2024-11-18Open, ClassifiedProcess change control

  Acrobat-i Vacuum Stabilizer System. Model Number C-OM-10000Z

  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.

• 2023-12-19Open, ClassifiedComponent design/selection

  Acrobat-i Vacuum Positioner System, Model Number XP-5000Z

  The Positioner Arm may not tighten or lock during normal use.

• 2023-10-22Open, ClassifiedDevice Design

  Maquet Acrobat-i Vacuum Stabilizer System Intended for use during performance of cardiac surgical procedures through a sternotomy incision approach. Product Code: OM-10000Z

  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.

• 2017-02-22TerminatedOther

  Titan" Stabilizer Attachment and Titan TM 360 Stabilizer Attachment

  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. Although the clip is for convenience purposes and is not required for device operation, there is a potential for broken Suction Tubing Clip fragments to fall into the surgical site.