Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
FDA adverse event reports and recall history for catheter, cannula and tubing, vascular, cardiopulmonary bypass (product code DWF), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 6,128
- Deaths
- 300
- Injuries
- 1,231
- Malfunctions
- 4,448
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
- 2026-07-15Open, 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.
- 2026-05-20Open, 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.
- 2026-05-20Open, ClassifiedPackaging process control
Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model 94913; 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 13FR, Model 94913L; 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 94915; Cardiopulmonary bypass vascular catheter
Certain lots of product have the potential for a sterile barrier breach.
Monitor catheter, cannula and tubing, vascular, cardiopulmonary bypass 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.