Medtronic Perfusion Systems
FDA adverse event reports naming Medtronic Perfusion Systems as the device manufacturer, with recall history from the live FDA recall database. Reporter-supplied name as filed: MEDTRONIC PERFUSION SYSTEMS.
- Total reports
- 1,317
- Deaths
- 77
- Injuries
- 260
- Malfunctions
- 966
Reports per year
Source: FDA adverse event reports by year received, 2011–2026. Reporting paused twice in 2026 during FDA reporting-system changes and has since resumed.
Top device categories
- Oxygenator, Cardiopulmonary BypassDTZ532
- Catheter, Cannula And Tubing, Vascular, Cardiopulmonary BypassDWF270
- Reservoir, Blood, Cardiopulmonary BypassDTN67
- Dialyzer, High Permeability With Or Without Sealed Dialysate SystemKDI57
- Pump, Blood, Cardiopulmonary Bypass, Non-Roller TypeKFM53
- Tubing, Pump, Cardiopulmonary BypassDWE46
- Control, Pump Speed, Cardiopulmonary BypassDWA43
- Stabilizer, HeartMWS31
- Clip, ImplantableFZP25
- Heat-Exchanger, Cardiopulmonary BypassDTR18
Recent recalls
- 2026-07-27Open, ClassifiedUnder Investigation by firm
EOPA Elongated One-Piece Arterial Cannula BLUNT 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Number 77422
Medtronic received reports of pinhole leaks in the wire-wound body of 22 Fr EOPA 3D Arterial Cannulae and EOPA Elongated One-Piece Arterial Cannulae used during cardiopulmonary bypass procedures.
- 2026-07-27Open, ClassifiedUnder Investigation by firm
EOPA Elongated One-Piece Arterial Cannula BLUNT 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Number 77522
Medtronic received reports of pinhole leaks in the wire-wound body of 22 Fr EOPA 3D Arterial Cannulae and EOPA Elongated One-Piece Arterial Cannulae used during cardiopulmonary bypass procedures.
- 2026-07-27Open, ClassifiedUnder Investigation by firm
EOPA Elongated One-Piece Arterial Cannula DIL TIP 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Number 77622
Medtronic received reports of pinhole leaks in the wire-wound body of 22 Fr EOPA 3D Arterial Cannulae and EOPA Elongated One-Piece Arterial Cannulae used during cardiopulmonary bypass procedures.
- 2026-07-27Open, ClassifiedUnder Investigation by firm
EOPA Elongated One-Piece Arterial Cannula DIL TIP 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Number 77722
Medtronic received reports of pinhole leaks in the wire-wound body of 22 Fr EOPA 3D Arterial Cannulae and EOPA Elongated One-Piece Arterial Cannulae used during cardiopulmonary bypass procedures.
- 2026-07-27Open, ClassifiedUnder Investigation by firm
EOPA 3D Arterial Cannula DIL TIP 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Number 78222
Medtronic received reports of pinhole leaks in the wire-wound body of 22 Fr EOPA 3D Arterial Cannulae and EOPA Elongated One-Piece Arterial Cannulae used during cardiopulmonary bypass procedures.
- 2026-07-27Open, ClassifiedUnder Investigation by firm
EOPA 3D Arterial Cannula 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Number 78322
Medtronic received reports of pinhole leaks in the wire-wound body of 22 Fr EOPA 3D Arterial Cannulae and EOPA Elongated One-Piece Arterial Cannulae used during cardiopulmonary bypass procedures.
- 2026-07-15Open, ClassifiedPackaging
Medtronic DLP One-Piece Pediatric Arterial Cannula, Product Number/CFN 77010; Cardiopulmonary bypass vascular cannula
Medtronic received two complaints of loose foreign material confirmed as containing trace levels of blood.
- 2026-07-15Open, ClassifiedPackaging
Medtronic Bio-Medicus Adult Cannula Kit, Product Number/CFN 96530-115; Cardiopulmonary bypass vascular cannula
Medtronic received two complaints of loose foreign material confirmed as containing trace levels of blood.
- 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.
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