Coloplast A/S
FDA adverse event reports naming Coloplast A/S as the device manufacturer, with recall history from the live FDA recall database. Reporter-supplied name as filed: COLOPLAST A/S.
- Total reports
- 18,307
- Deaths
- 14
- Injuries
- 14,573
- Malfunctions
- 3,711
Reports per year
19612
62613
48214
17315
49416
71217
97118
1,17919
1,30020
1,92521
1,56822
2,00423
2,51924
2,55225
1,38726
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
- Device, Impotence, Mechanical/HydraulicFHW11,508
- Mesh, Surgical, PolymericFTL1,287
- Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-SlingPAH1,278
- Catheter, Retention Type, BalloonEZL1,159
- Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or TransobturatorOTN593
- Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally PlacedOTO437
- Prosthesis, PenileFAE353
- Lavage, JetFQH295
- Catheter, UrethralGBM237
- Stent, UreteralFAD214
Recent recalls
No recalls listed in the FDA device recall database for this entry.
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