Stabilizer, Heart
FDA product code MWS · Class I (low risk) · 21 CFR 870.4500 · Cardiovascular
4510(k) clearances
0PMA approvals
17recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K041338 | Medtronic Octopus Te Stabilizer & AccessoriesMWS · Traditional | Medtronic Vascular | 07/19/2004SE |
| K992476 | Pilling Weck Surgical Heart Stabilizer Removable PadsMWS · Traditional | Pilling Weck Surgical | 09/13/2000SE |
| K992833 | Vacuum Assist StabilizerMWS · Traditional | Cardio Thoracic Systems | 11/10/1999SE |
| K982419 | Heart-Lift Balloon PositionerMWS · Traditional | Cardiothoracic Systems, Inc. | 01/13/1999SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2577-2026 Class II | Octopus 4 Tissue Stabilizer, Model 29400During the manufacturing process, Medtronic personnel identified an assembly issue where the tubing was… | Medtronic Perfusion Systems | 05/12/2026Open, Classified |
| Z-2576-2026 Class II | Octopus Evolution AS Tissue Stabilizer, Model TS2500During the manufacturing process, Medtronic personnel identified an assembly issue where the tubing was… | Medtronic Perfusion Systems | 05/12/2026Open, Classified |
| Z-2575-2026 Class II | Octopus Evolution Tissue Stabilizer, Model TS2000During the manufacturing process, Medtronic personnel identified an assembly issue where the tubing was… | Medtronic Perfusion Systems | 05/12/2026Open, Classified |
| Z-1473-2026 Class II | Octopus Nuvo Tissue Stabilizer, disposable tissue stabilization system, Product Number…During the manufacturing, Medtronic personnel identified an assembly issue where the tubing was incorrectly… | Medtronic Perfusion Systems | 01/13/2026Open, Classified |
| Z-0486-2025 Class II | Acrobat-i Vacuum Stabilizer System. Model Number C-OM-10000ZDeviations in the manufacturing process created a compromise in the sterile barrier, in which sterility… | Maquet Cardiovascular, LLC | 10/16/2024Open, Classified |
| Z-0485-2025 Class II | Acrobat SUV Vacuum Stabilizer System, ST. Model Number C-OM-9000ZDeviations in the manufacturing process created a compromise in the sterile barrier, in which sterility… | Maquet Cardiovascular, LLC | 10/16/2024Open, Classified |
| Z-0484-2025 Class II | Acrobat-i Positioner. Model Number C-XP-5000ZDeviations in the manufacturing process created a compromise in the sterile barrier, in which sterility… | Maquet Cardiovascular, LLC | 10/16/2024Open, Classified |
| Z-0589-2024 Class II | Acrobat-i Vacuum Positioner System, Model Number XP-5000ZThe Positioner Arm may not tighten or lock during normal use. | Maquet Cardiovascular, LLC | 10/31/2023Open, Classified |
| Z-0137-2024 Class II | Maquet Acrobat-i Vacuum Stabilizer System Intended for use during performance of cardiac…Housing Mount Jaw of these devices breaking during normal use and may result in injury to the epicardial… | Maquet Cardiovascular, LLC | 09/13/2023Open, Classified |
| Z-1367-2021 Class II | Consist of a distal connection mechanism (either standard Terumo Ball Quick Connect or…There is a potential for the stainless steel locking plates on the device's sternal retractor locking… | Terumo Cardiovascular Systems Corporation | 03/02/2021Terminated |
| Z-1232-2017 Class II | Titan" Stabilizer Attachment and Titan TM 360 Stabilizer AttachmentTerumo Cardiovascular Systems (Terumo CVS) is voluntarily recalling certain lots of Titan" Stabilizers and… | Terumo Cardiovascular Systems Corporation | 01/05/2015Terminated |
| Z-1201-2017 Class II | Hercules 360 Universal Stabilizing Arm, top mount, 360-degree rotation, reusable…Terumo Cardiovascular Systems (Terumo CVS) is recalling certain lots of Hercules TM 360 Universal… | Terumo Cardiovascular Systems Corporation | 08/20/2014Terminated |
| Z-0132-2015 Class II | Acrobat V Vacuum Off-Pump System OM-9100S Acrobat SUV Vacuum Off-Pump System OM-9000S…An internal finding identified the presence of pinholes/cuts in some of the Tyvek pouches of the vacuum… | Maquet Cardiovascular, LLC | 08/13/2014Terminated |
| Z-0968-2012 | XPOSE 4 Access Device (XP-4000) XPOSE 3 Access Device (XP-3000) positioners. Product…There may be a small perforation in the sterile pouch of select lots of the ACROBAT V, ACROBAT SUV, and… | Maquet Cardiovascular, LLC | 11/16/2011Terminated |
| Z-0967-2012 | ACROBAT Stabilizers- ACROBAT V Vacuum Off-Pump System (OM-91 OOS), ACROBAT SUV Vacuum…There may be a small perforation in the sterile pouch of select lots of the ACROBAT V, ACROBAT SUV, and… | Maquet Cardiovascular, LLC | 11/16/2011Terminated |
| Z-0612-2007 | Guidant Acrobat Vacuum Stabilizer, Model number-OM-9100Vacuum Tubing Failure- vacuum tubing fails before the labeled two year shelf life. This may result in… | Guidant Cardiac Surgery | 12/01/2006Terminated |
| Z-0611-2007 | Guidant Acrobat Vacuum Stabilizer, Model Number OM-9000.Vacuum Tubing Failure- vacuum tubing fails before the labeled two year shelf life. This may result in… | Guidant Cardiac Surgery | 12/01/2006Terminated |