GenesisRecalls & reported problems across all models
Coloplast A/S · 3 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 162
- Deaths reported
- 0
- Injuries reported
- 152
- Recalls
- 0
We found 3 models of Genesis by Coloplast A/S in the FDA's device registry (GUDID). Together they are named in 162 adverse event reports in the FDA's MAUDE database, received between Jul 7, 2017 and Jun 4, 2026 — classified as 152 injuries, 10 malfunctions.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (32 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Genesis problems
Device problems
- Adverse Event Without Identified Device or Use Problem65
- Insufficient Device Problem Information32
- Inadequacy of Device Shape and/or Size18
- Device Operates Differently Than Expected6
- Migration6
- Appropriate Device Problem Term/Code Not Available5
- Malposition of Device5
- Material Erosion4
Patient problems
- No Clinical Signs, Symptoms or Conditions45
- Unspecified Infection45
- Erosion27
- No Information20
- Pain14
- No Known Impact Or Consequence To Patient6
- Skin Erosion6
- Bacterial Infection5
Genesis models
3 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Genesis 91-9511SCPROSTHESIS, PENILE85 reports
- Genesis 91-9509SCPROSTHESIS, PENILE49 reports
- Genesis 91-9513SCPROSTHESIS, PENILE28 reports
Recent Genesis adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryJun 4, 2026Adverse Event Without Identified Device or Use Problem
ACCORDING TO THE AVAILABLE INFORMATION, THE GENESIS IMPLANT WAS REMOVED AND REPLACED WITH A TITAN DUE TO AN INFECTION.
Patient problems: Unspecified Infection
MAUDE report 25391516 ↗InjuryJun 1, 2026Adverse Event Without Identified Device or Use Problem
ACCORDING TO THE AVAILABLE INFORMATION, THE IMPLANT WAS REMOVED AND REPLACED DUE TO AN INFECTION.
Patient problems: Unspecified Infection
MAUDE report 25349187 ↗InjuryMay 21, 2026Inadequacy of Device Shape and/or Size
ACCORDING TO THE AVAILABLE INFORMATION, THE IMPLANT WAS REMOVED AND REPLACED DUE TO INCORRECT SIZING. IT WAS NOTED THE PATIENT WANTED TO SWITCH TO A 11 MM FROM A 9.5 MM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25241855 ↗InjuryApr 22, 2026Adverse Event Without Identified Device or Use Problem
ACCORDING TO THE AVAILABLE INFORMATION, LEFT CYLINDER PREVIOUSLY REMOVED DUE TO EROSION ON AN UNKNOWN DATE. NEW LEFT CYLINDER ADDED IN (B)(6) 2025.
Patient problems: Erosion
MAUDE report 24955109 ↗InjuryApr 16, 2026Inadequacy of Device Shape and/or Size
ACCORDING TO THE AVAILABLE INFORMATION, IMPLANT REMOVED AND REPLACED DUE TO EROSION FROM AN OVERSIZED IMPLANT.
Patient problems: Erosion
MAUDE report 24895229 ↗InjuryApr 10, 2026Inadequacy of Device Shape and/or Size
ACCORDING TO THE AVAILABLE INFORMATION, THE GENESIS IMPLANT WAS REMOVED AND REPLACED WITH A TITAN TOUCH DUE TO INCORRECT SIZING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24839582 ↗InjuryApr 7, 2026Malposition of Device
ACCORDING TO THE AVAILABLE INFORMATION, THE GENESIS IMPLANT WAS REMOVED AND REPLACED WITH A TITAN DUE TO CROSS OVER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24809214 ↗InjuryApr 6, 2026Adverse Event Without Identified Device or Use Problem
ACCORDING TO THE AVAILABLE INFORMATION, THE MALLEABLE IMPLANT WAS REMOVED AND REPLACED WITH A TITAN INFLATABLE PENILE PROSTHESIS DUE TO IMMINENT EROSION.
Patient problems: Erosion
MAUDE report 24794676 ↗InjuryFeb 23, 2026Device Appears to Trigger Rejection
ACCORDING TO THE AVAILABLE INFORMATION, THE EXTRUDED CYLINDER WAS REMOVED AND THE SYSTEM WAS CAPPED.
Patient problems: Erosion
MAUDE report 24422340 ↗InjuryFeb 23, 2026Inadequacy of Device Shape and/or Size
ACCORDING TO THE AVAILABLE INFORMATION THE DEVICE WAS REMOVED AND REPLACED DUE TO PATIENT PREFERENCE. GENESIS SWITCHED FOR ANOTHER GENESIS AS PATIENT GAINED LENGTH.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24419264 ↗InjuryJan 8, 2026Adverse Event Without Identified Device or Use Problem
ACCORDING TO THE AVAILABLE INFORMATION THE DEVICE WAS EXPLANTED AND REPLACED DUE TO INFECTION. IT WAS NOTED THERE WAS A MASS FILLED WITH FLUID.
Patient problems: Unspecified Infection
MAUDE report 24006009 ↗InjuryDec 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ACCORDING TO THE AVAILABLE INFORMATION, THE DEVICE WAS EXPLANTED AND REPLACED DUE TO AN INFECTION.
Patient problems: Unspecified Infection
MAUDE report 23681444 ↗InjurySep 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ACCORDING TO THE AVAILABLE INFORMATION THE DEVICE WAS EXPLANTED AND FOLEY CATHETER INSERTED DUE TO INFECTION WITH EROSION OF RIGHT CORPORAL IMPLANT THROUGH THE DISTAL MEATUS AND URETHRA. NO GROSS POCKETS OF PURULENCE.
Patient problems: Erosion; Unspecified Infection
MAUDE report 23166355 ↗InjuryAug 28, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
ACCORDING TO THE AVAILABLE INFORMATION THE DEVICE WAS EXPLANTED AND REPLACED DUE TO AN UNSPECIFIED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22911857 ↗InjuryAug 26, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
ACCORDING TO THE AVAILABLE INFORMATION THE DEVICE WAS EXPLANTED AND REPLACED DUE TO AN UNSPECIFIED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22897738 ↗
Other Coloplast A/S products
All Coloplast A/S devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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