Genesis 91-9511SCRecalls & reported problems
Coloplast A/S · Malleable Penile Prosthesis · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This Coloplast Genesis malleable penile implant has 85 reports in the FDA database, with no deaths and 76 injuries. Many reports describe the implant being removed and replaced because of infection, erosion or the wrong size, and some describe an extruded cylinder. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 85
- Deaths reported
- 0
- Injuries reported
- 76
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 85 adverse event reports that list this exact device (DI 05708932324748), received between Jul 7, 2017 and Jun 4, 2026 — classified as 76 injuries, 9 malfunctions.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (18 reports).
1 other recall cover devices cleared under the same FDA submission (K040959); they may or may not involve this specific model.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem35
- Insufficient Device Problem Information18
- Inadequacy of Device Shape and/or Size8
- Malposition of Device4
- Material Erosion4
- Device Operates Differently Than Expected3
- Fracture3
- Appropriate Device Problem Term/Code Not Available2
Patient problems
- No Clinical Signs, Symptoms or Conditions23
- Unspecified Infection22
- Erosion13
- No Information12
- Pain8
- No Code Available3
- No Known Impact Or Consequence To Patient3
- Wound Dehiscence3
Recent adverse event reports
The 25 most recent of 85 reports, 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 ↗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 ↗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 ↗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 ↗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 ↗MalfunctionAug 18, 2025Unintended System Motion; Unintended System Motion
ACCORDING TO THE AVAILABLE INFORMATION, THE PATIENT IS UNABLE TO GET HIS GENESIS PENILE IMPLANT TO GO DOWN TO A FLACCID STATE. EACH TIME HE TRIES TO MANUALLY LOWER THE DEVICE IT COMES BACK UP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22834372 ↗InjuryJun 27, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
ACCORDING TO THE AVAILABLE INFORMATION THE MALLEABLE DEVICE WAS EXPLANTED AND LATER REPLACED WITH A TITAN FOR AN UNKNOWN REASON.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22345049 ↗InjuryJun 17, 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 IMPENDING DISTAL EROSION AND PATIENT PREFERENCE.
Patient problems: Erosion
MAUDE report 22235109 ↗InjuryMay 12, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
ACCORDING TO THE AVAILABLE INFORMATION, THE IMPLANT WAS REMOVED AND REPLACED DUE TO AN UNKNOWN REASON.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22004742 ↗InjuryApr 23, 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 INFECTION.
Patient problems: Unspecified Infection
MAUDE report 21892336 ↗InjuryFeb 5, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
ACCORDING TO THE AVAILABLE INFORMATION, THE DEVICE WAS EXPLANTED AND ULTIMATELY REPLACED DUE TO AN UNKNOWN REASON.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21312570 ↗InjuryJan 23, 2025Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information
ACCORDING TO THE AVAILABLE INFORMATION, THE IMPLANT WAS REMOVED AND ULTIMATELY REPLACED DUE TO AN UNKNOWN REASON.
Patient problems: No Clinical Signs, Symptoms or Conditions; Unspecified Infection
MAUDE report 21218063 ↗InjuryJan 20, 2025Malposition of Device; Malposition of Device
ACCORDING TO THE AVAILABLE INFORMATION, THE ORIGINAL IMPLANT WAS INCORRECTLY PLACED ON THE DISTAL END AS IT WAS NOT PUT INTO THE CORPORA. THE PROXIMAL END WAS IN THE CORPORA. DURING THE REVISION SURGERY, THE IMPLANT WAS THEN REMOVED AND REPLACED, CORRECTLY SETTING THE IMPLANT INTO THE CORPORA BOTH DISTALLY AND PROXIMALLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21191448 ↗InjuryDec 27, 2024Adverse 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 EROSION.
Patient problems: Erosion
MAUDE report 21026651 ↗InjuryDec 19, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
ACCORDING TO THE AVAILABLE INFORMATION, THE IMPLANT WAS REMOVED DUE TO AN UNKNOWN REASON, AND IT IS NOT KNOWN IF THE DEVICE WAS REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20976628 ↗InjuryDec 9, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
ACCORDING TO THE AVAILABLE INFORMATION, IMPLANT WAS REMOVED FOR AN UNSPECIFIED PROCEDURE / REASON AND REPLACED AT A LATER DATE. THE DETAILS SURROUNDING THE EXPLANT WERE NOT PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20878908 ↗InjuryNov 13, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
ACCORDING TO THE AVAILABLE INFORMATION, THE DEVICE WAS EXPLANTED AND REPLACED DUE TO AN UNKNOWN REASON.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20674784 ↗InjuryNov 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ACCORDING TO THE AVAILABLE INFORMATION, THE IMPLANT WAS REMOVED DUE TO A SUSPECTED INFECTION. NO REPLACEMENT DEVICE IMPLANTED.
Patient problems: Unspecified Infection
MAUDE report 20663103 ↗InjuryAug 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ACCORDING TO THE AVAILABLE INFORMATION, THE IMPLANT WAS REMOVED AND REPLACED DUE TO INFECTION.
Patient problems: Unspecified Infection
MAUDE report 20081670 ↗InjuryJul 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ACCORDING TO THE AVAILABLE INFORMATION, THE IMPLANT WAS REMOVED DUE TO EROSION.
Patient problems: Erosion
MAUDE report 19817268 ↗InjuryJun 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ACCORDING TO THE AVAILABLE INFORMATION, THE ROD ON THE RIGHT SIDE WAS REMOVED AND REPLACED DUE TO IMPENDING EROSION.
Patient problems: Erosion
MAUDE report 19524416 ↗InjuryApr 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ACCORDING TO THE AVAILABLE INFORMATION THE DEVICE WAS EXPLANTED DUE TO AN INFECTION.
Patient problems: Unspecified Infection
MAUDE report 19034441 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K040959. One submission often covers many models, so check the product and lot details in each record.
- Z-1538-2015 · Apr 9, 2015 · TerminatedGenesis Malleable Penile Prosthesis, 9.5 mm, Catalog /Item Number 91-9509SC/519250. Product Usage: The Coloplast Genesis Penile prosthesis is a flexible silicone elastomer device
Other PROSTHESIS, PENILE devices
- TACTRA 720081-01Boston Scientific Corporation · PROSTHESIS, PENILE150 reports
- Spectra 720074-02American Medical Systems, Inc. · Prosthesis, Penile97 reports
- TACTRA 720080-01Boston Scientific Corporation · PROSTHESIS, PENILE61 reports
- Genesis 91-9509SCColoplast A/S · PROSTHESIS, PENILE49 reports
- TACTRA 720082-01Boston Scientific Corporation · PROSTHESIS, PENILE49 reports
- Spectra 720074-03American Medical Systems, Inc. · Prosthesis, Penile47 reports
- Spectra 720054-02American Medical Systems, Inc. · Prosthesis, Penile44 reports
- Genesis 91-9513SCColoplast A/S · PROSTHESIS, PENILE28 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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