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 during the 2026 MAUDE-to-AEMS transition 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
- 2026-07-15Open, 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.
- 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.
- 2026-05-20Open, ClassifiedPackaging process control
Medtronic GUNDRY Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model 94113T; Cardiopulmonary bypass vascular catheter
Certain lots of product have the potential for a sterile barrier breach.
- 2026-05-20Open, ClassifiedPackaging process control
Medtronic GUNDRY Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94115T; Cardiopulmonary bypass vascular catheter
Certain lots of product have the potential for a sterile barrier breach.
- 2026-05-20Open, ClassifiedPackaging process control
Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94215T; Cardiopulmonary bypass vascular catheter
Certain lots of product have the potential for a sterile barrier breach.
- 2026-05-20Open, ClassifiedPackaging process control
Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94665; Cardiopulmonary bypass vascular catheter
Certain lots of product have the potential for a sterile barrier breach.
- 2026-05-20Open, ClassifiedPackaging process control
Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94725; Cardiopulmonary bypass vascular catheter
Certain lots of product have the potential for a sterile barrier breach.
Monitor Medtronic Perfusion Systems automatically
DeviceWatch watches FDA adverse events and recalls for the products you care about, summarizes clinical narratives with AI and alerts you when a safety signal emerges.