American Medical Systems (mn)
FDA adverse event reports naming American Medical Systems (mn) as the device manufacturer, with recall history from the live FDA recall database. Reporter-supplied name as filed: AMERICAN MEDICAL SYSTEMS (MN).
- Total reports
- 1,265
- Deaths
- 172
- Injuries
- 1,077
- Malfunctions
- 16
Reports per year
53614
50815
18916
3217
Source: FDA adverse event reports by year received, 2014–2017. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Top device categories
- Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally PlacedOTP321
- Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or TransobturatorOTN293
- Prosthesis, PenileFAE277
- Mesh, Surgical, For Stress Urinary Incontinence, MaleOTM115
- Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-SlingPAH90
- Implanted Fecal Incontinence DeviceMIP77
- Device, Impotence, Mechanical/HydraulicFHW21
- System, Hyperthermia, Rf/Microwave (Benign Prostatic Hyperplasia),ThermotherapyMEQ19
- Screw, Fixation, BoneHWC15
- Device, Incontinence, Mechanical/HydraulicEZY13
Recent recalls
No recalls listed in the FDA device recall database for this entry.
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