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
- 18,398
- Deaths
- 14
- Injuries
- 14,691
- Malfunctions
- 3,684
Reports per year
19612
62613
48214
17315
49416
71217
97118
1,17919
1,30020
1,92521
1,56822
2,00423
2,51724
2,54925
1,48326
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused twice in 2026 during FDA reporting-system changes and has since resumed.
Top device categories
- Device, Impotence, Mechanical/HydraulicFHW11,630
- Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-SlingPAH1,294
- Mesh, Surgical, PolymericFTL1,287
- Catheter, Retention Type, BalloonEZL1,116
- Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or TransobturatorOTN594
- Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally PlacedOTO436
- Prosthesis, PenileFAE354
- Lavage, JetFQH293
- Catheter, UrethralGBM237
- Stent, UreteralFAD209
Recent recalls
No recalls listed in the FDA device recall database for this entry.
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