Mentor
FDA adverse event reports naming Mentor as the device manufacturer, with recall history from the live FDA recall database. Reporter-supplied name as filed: MENTOR.
- Total reports
- 3,102
- Deaths
- 8
- Injuries
- 2,435
- Malfunctions
- 310
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.
Top device categories
- Prosthesis, Breast, Inflatable, Internal, SalineFWM1,614
- Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-FilledFTR1,100
- Mesh, Surgical, PolymericFTL223
- Tissue Expander And AccessoriesLCJ89
- Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or TransobturatorOTN30
- Device, Impotence, Mechanical/HydraulicFHW28
- Mammary SizerMRD11
- Prosthesis, PenileFAE9
- Product code 5
- Implant, Anti-Gastroesophageal RefluxLEI5
Recent recalls
- 2008-12-12TerminatedPackage design/selection
Mentor Aseptic Transfer Set, Cat. #350-8400 (contains BD 60mL Luer-Lok Syringe). Aseptic transfer set manufactured by Mentor Texas, LP, Irving, TX 75038 (BD 60 mL Luer-Lok syringe manufactured by Becton Dickinson, Franklin Lakes, NJ 07417).
The Mentor Aseptic Transfer Set contains a component, the BD 60mL Luer-Lok Syringe, which is under recall by Becton Dickinson due to a package integrity issue.
- 2008-09-05TerminatedOther
Psi-Tec Tubing, 12'; 10/box; Part Number PT-5558; distributed by Mentor Texas, LP, Irving, TX 75038.
During packaging integrity validation, it was found that various product packages could fail, compromising the sterility of the devices.
- 2008-09-05TerminatedOther
Autofuse Tubing, DIS SI; Part Number AFTU-DS; distributed by Mentor Texas, LP, Irving, TX 75038.
During packaging integrity validation, it was found that various product packages could fail, compromising the sterility of the devices.
- 2008-09-05TerminatedOther
Hi-Vac Tubing, 8'; 10/box; Part Number B-5558; distributed by Mentor Texas, LP, Irving, TX 75038.
During packaging integrity validation, it was found that various product packages could fail, compromising the sterility of the devices.
- 2008-09-05TerminatedOther
Lamis Tubing Set, 9'; 10/box; Part Number LAM-TUBING; distributed by Mentor Texas, LP, Irving, TX 75038.
During packaging integrity validation, it was found that various product packages could fail, compromising the sterility of the devices.
- 2008-09-05TerminatedOther
Y Tubing Set, 9'; 10/box; Part Number LAM-Y; distributed by Mentor Texas, LP, Irving, TX 75038.
During packaging integrity validation, it was found that various product packages could fail, compromising the sterility of the devices.
- 2008-09-05TerminatedOther
Irrigation Tubing, 25'; Part Number 5120-25; distributed by Mentor Texas, LP, Irving, TX 75038.
During packaging integrity validation, it was found that various product packages could fail, compromising the sterility of the devices.
- 2008-09-05TerminatedOther
Psi-Tec Syringe Pump Infiltration Tubing, 10'; 10/box; Part Number PT-INF-T; distributed by Mentor Texas, LP, Irving, TX 75038.
During packaging integrity validation, it was found that various product packages could fail, compromising the sterility of the devices.
- 2008-09-05TerminatedOther
Contour Genesis Infiltration Tubing, 13'; Part Number CG-INF-T; distributed by Mentor Texas, LP, Irving, TX 75038.
During packaging integrity validation, it was found that various product packages could fail, compromising the sterility of the devices.
- 2008-09-05TerminatedOther
Contour Genesis Inf/IR Tubing; Part Number CG-UT; distributed by Mentor Texas, LP, Irving, TX 75038.
During packaging integrity validation, it was found that various product packages could fail, compromising the sterility of the devices.
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