Genesis 91-9513SCRecalls & 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 prosthesis is a surgically implanted implant for the penis. The 28 reports describe implants being taken out and replaced, mainly because of erosion of the surrounding tissue, infection, pain, or a shape or size that did not work well, and several mention problems where the prosthesis moved or broke without any clear cause. All 28 reports involve injuries and none describe a death. 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
- 28
- Deaths reported
- 0
- Injuries reported
- 28
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 05708932324809), received between Jul 31, 2017 and Apr 22, 2026 — classified as 28 injuries.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (5 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 Problem10
- Insufficient Device Problem Information5
- Inadequacy of Device Shape and/or Size3
- Extrusion2
- Mechanical Problem2
- Migration2
- Crack1
- Material Protrusion/Extrusion1
Patient problems
- Unspecified Infection9
- No Clinical Signs, Symptoms or Conditions6
- Erosion5
- No Information3
- Pain3
- Discomfort1
- Ecchymosis1
- Fungal Infection1
Recent adverse event reports
The 25 most recent of 28 reports, in the reporter's own words as published by the FDA.
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 ↗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 ↗InjuryMar 4, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
ACCORDING TO THE AVAILABLE INFORMATION, THE DEVICE IMPLANTED AS A PLACEHOLDER. THE DEVICE WAS EXPLANTED AND REPLACED WITH THE PLANNED IMPLANTABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21514577 ↗InjuryJan 29, 2025Insufficient Device Problem Information; 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
MAUDE report 21266646 ↗InjuryNov 15, 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 20695246 ↗InjurySep 11, 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 INFECTION. THE EXPLANT DETAILS ARE UNKNOWN.
Patient problems: Unspecified Infection
MAUDE report 20189945 ↗InjuryJul 10, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
ACCORDING TO THE AVAILABLE INFORMATION THE GENESIS DEVICE WAS EXPLANTED AT AN UNKNOWN DATE AND FACILITY. THE PATIENT WAS IMPLANTED WITH A NEW GENESIS DEVICE WHEN IT WAS FOUND THAT THE PATIENT WAS EXPLANTED WITH A RIGICON IMPLANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19713484 ↗InjuryNov 16, 2023Crack; Crack
ACCORDING TO THE AVAILABLE INFORMATION THE DEVICE WAS EXPLANTED AND REPLACED DUE TO NOT ACHIEVING SUFFICIENT ERECTION.
Patient problems: Sensitivity of Teeth
MAUDE report 18151184 ↗InjuryMay 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE REQUIRED REPLACEMENT DUE TO INFECTION. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: Unspecified Infection
MAUDE report 17020438 ↗InjuryFeb 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE REQUIRED EXPLANTATION DUE TO INFECTION. AN INFLATABLE PENILE PROSTHESIS WAS IMPLANTED. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: Unspecified Infection
MAUDE report 16438559 ↗InjuryFeb 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE REQUIRED REPLACEMENT DUE TO INFECTION. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: Unspecified Infection
MAUDE report 16369833 ↗InjuryDec 13, 2022Positioning Problem; Migration; Positioning Problem; Migration
ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE REQUIRED REPLACEMENT DUE TO MIGRATION. THE CYLINDER MIGRATED INTO THE SCROTUM. IT WAS NOTED THAT THE PREVIOUS DOCTOR MISPLACED THE ORIGINAL CYLINDER. THE PATIENT ALSO HAD INFECTION. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: Unspecified Infection
MAUDE report 15973129 ↗InjuryOct 18, 2022Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size
ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE REQUIRED EXPLANTATION DUE TO SIZE. THE DEVICE WAS CAUSING A URINARY OBSTRUCTION. A 13 MM SIZE WAS EXPLANTED, AND A 9.5 MM SIZE DEVICE WAS IMPLANTED. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: Obstruction/Occlusion
MAUDE report 15624328 ↗InjuryOct 11, 2022Migration; Migration
ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE REQUIRED REPLACEMENT DUE TO IMPENDING EROSION. BOTH CYLINDERS WERE REMOVED AND ONLY THE LEFT CYLINDER WAS REPLACED. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: Erosion
MAUDE report 15576530 ↗InjuryDec 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE REQUIRED REPLACEMENT DUE TO EROSION. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: Skin Erosion
MAUDE report 13060179 ↗InjuryNov 12, 2021No Apparent Adverse Event; No Apparent Adverse Event
THIS REPORT IS A FOLLOW-UP TO MFR# 2125050-2020-00025. ACCORDING TO THE AVAILABLE INFORMATION A GENESIS MALLEABLE WAS IMPLANTED ON (B)(6) 2017 AND REMOVED ON (B)(6) 2019 DUE TO A MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12804703 ↗InjuryMay 25, 2021Patient Device Interaction Problem; Patient Device Interaction Problem
ACCORDING TO AVAILABLE INFORMATION, PATIENTS EXPERIENCED PAIN AND/OR INFECTION. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: Pain; Unspecified Infection
MAUDE report 11879169 ↗InjuryMay 25, 2021Patient-Device Incompatibility; Patient-Device Incompatibility
ACCORDING TO AVAILABLE INFORMATION, THE PATIENT EXPERIENCED PAIN, HYPEREMIA, ECCHYMOSIS, EDEMA, AND NECROSIS DUE TO FUNGAL INFECTION. THE PATIENT UNDERWENT PENILE AMPUTATION SURGERY.
Patient problems: Ecchymosis; Fungal Infection; Necrosis; Pain; Swelling/ Edema
MAUDE report 11879089 ↗InjuryNov 20, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ACCORDING TO THE AVAILABLE INFORMATION, THE PATIENT EXPERIENCED PAIN AND DISCOMFORT. THE DEVICE WAS REMOVED AND REPLACED WITH ANOTHER MANUFACTURER'S PRODUCT.
Patient problems: Discomfort; Pain
MAUDE report 10875317 ↗InjuryAug 11, 2020Mechanical Problem; Mechanical Problem
ACCORDING TO THE AVAILABLE INFORMATION, MALFUNCTION AND INFECTION WERE REPORTED. THE DEVICE WAS REMOVED/REPLACED.
Patient problems: Unspecified Infection
MAUDE report 10393375 ↗InjuryJan 22, 2020Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size
ACCORDING TO THE AVAILABLE INFORMATION, THE NATURE OF THE REVISION SURGERY WAS NOTED AS SIZE. THE MALLEABLE DEVICE WAS REMOVED DUE TO RISK OF EROSION, NO EROSION HAD OCCURRED. IT WAS NOTED THAT THE PATIENT WANTED AN INFLATABLE DEVICE.
Patient problems: No Information
MAUDE report 9618624 ↗InjuryJan 10, 2020Mechanical Problem; Mechanical Problem
ACCORDING TO THE AVAILABLE INFORMATION, MALFUNCTION WAS REPORTED. THE DEVICE WAS REPLACED WITH AN INFLATABLE PROSTHESIS.
Patient problems: No Information
MAUDE report 9576257 ↗InjuryJan 8, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ACCORDING TO THE AVAILABLE INFORMATION, A MALLEABLE DEVICE WAS USED FOR SPACERS. THE DEVICE WAS EXPLANTED AND REPLACED WITH AN INFLATABLE PROSTHESIS.
Patient problems: No Information
MAUDE report 9566777 ↗InjuryDec 18, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ACCORDING TO THE AVAILABLE INFORMATION AN INFECTION WAS REPORTED.
Patient problems: Unspecified Infection
MAUDE report 9491384 ↗InjuryOct 10, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ACCORDING TO THE AVAILABLE INFORMATION, THE GENESIS MALLEABLE WAS BEING REMOVED DUE TO PATIENT PREFERENCE, TO IMPLANT AN INFLATABLE PROSTHESIS. UPON INCISION INTO THE CORPORA, THE PHYSICIAN OBSERVED BIOFILM PRESENT IN EACH CORPORA AND ON THE MALLEABLE RODS. DUE TO THE INFECTION, ANOTHER MALLEABLE DEVICE WAS PLACED INSTEAD OF THE INFLATABLE PROSTHESIS.
Patient problems: Unspecified Infection
MAUDE report 9176552 ↗
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
- Genesis 91-9511SCColoplast A/S · PROSTHESIS, PENILE85 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
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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