Genesis 91-9509SCRecalls & reported problems

Summary

The FDA's MAUDE database contains 49 adverse event reports that list this exact device (DI 05708932324687), received between Jul 11, 2017 and Jun 1, 2026 — classified as 48 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (9 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 49 reports, in the reporter's own words as published by the FDA.

• 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 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, 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 ↗
• 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 ↗
• InjuryMay 8, 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 EROSION.

  Patient problems: Erosion

  MAUDE report 21985310 ↗
• InjuryMar 10, 2025Inadequacy of Device Shape and/or Size; Insufficient Device Problem Information; Inadequacy of Device Shape and/or Size; Insufficient Device Problem Information

  ACCORDING TO THE AVAILABLE INFORMATION, THE DEVICE WAS EXPLANTED AND REPLACED DUE TO UNKNOWN REASONING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21560214 ↗
• InjuryJan 10, 2025No Apparent Adverse Event; Insufficient Device Problem Information; No Apparent Adverse Event; Insufficient Device Problem Information

  ACCORDING TO THE AVAILABLE INFORMATION, THE IMPLANT WAS REMOVED FOR AN UNKNOWN REASON AND REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21126201 ↗
• InjuryDec 19, 2024Adverse 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 AVAILABLE INFORMATION, THE MALLEABLE DEVICE THAT WAS IMPLANTED AS A PLACEHOLDER WAS REPLACED WITH AN IPP.

  Patient problems: Hematoma; No Clinical Signs, Symptoms or Conditions; Unspecified Infection

  MAUDE report 20978256 ↗
• InjuryNov 26, 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 20786888 ↗
• InjuryNov 26, 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 20785821 ↗
• InjuryOct 16, 2024Migration; Migration

  ACCORDING TO THE AVAILABLE INFORMATION, THE DEVICE WAS EXPLANTED AND REPLACED DUE TO CYLINDER MIGRATION AND POSSIBLE EROSION.

  Patient problems: Erosion

  MAUDE report 20463469 ↗
• InjuryOct 15, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  ACCORDING TO THE AVAILABLE INFORMATION, THE IMPLANT WAS REMOVED AND REPLACED DUE TO UNKNOWN REASONING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20454881 ↗
• InjuryAug 23, 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 20055502 ↗
• InjuryJul 17, 2024Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  ACCORDING TO THE AVAILABLE INFORMATION, THE IMPLANT WAS REMOVED AND REPLACED DUE TO AN INCORRECT SIZE. ONLY THE LEFT SIDE OF THE CORPORA WAS EXPLANTED AND IMPLANTED [REPLACED].

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19761293 ↗
• InjuryMay 13, 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 INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 19298219 ↗
• InjuryApr 24, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  ACCORDING TO THE AVAILABLE INFORMATION THE DEVICE WAS EXPLANTED AND REPLACED DUE TO UNKNOWN REASONS. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19176107 ↗
• InjuryJan 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE AVAILABLE INFORMATION THE PATIENT COMPLAINS OF INTERMITTENT PAIN AT THE SHAFT OF THE PENIS, ESPECIALLY DURING INTERCOURSE. ON PHYSICAL EXAMINATION - CYLINDERS ARE WELL LOCATED. SWELLING AND FULLNESS WERE NOTED AT THE DISTAL SHAFT OF THE PENIS ON THE RIGHT SIDE. ASSESSMENT ¿ RECURRENT INFECTION OF THE PENILE PROSTHESIS. PLAN ¿ EXPLORATORY SURGERY, INTRAOPERATIVE ASSESSMENT WITH REMOVAL OF INFECTED CYLINDERS IN CASE OF INFECTION. IN CASE OF ADEQUATE TISSUE AND LIMITED INFECTION. PLAN TO PERFORM A SALVAGE PROCEDURE WITH INTENTION TO IMPLANT NARROW CYLINDERS.

  Patient problems: Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 18426611 ↗
• InjuryNov 6, 2023Adverse 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 18074791 ↗
• InjuryMay 16, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  AS REPORTED TO COLOPLAST THE PATIENT HAVE REPLACEMENT AND REVISION SURGERY DUE TO AN UNSPECIFIED MALFUNCTION OF THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16942220 ↗
• InjuryMay 14, 2023Malposition of Device; Malposition of Device

  ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE REQUIRED REPLACEMENT DUE TO CROSSOVER. THERE WAS PROXIMAL CROSSOVER. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16928280 ↗
• InjuryMar 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  TITLE: COMPARISON OF PATIENT-REPORTED OUTCOMES AFTER PENILE PROSTHESIS PLACEMENT IN MEN WITH AND WITHOUT PEYRONIE'S DISEASE. WE EVALUATED OUTCOMES IN PATIENTS UNDERGOING PENILE PROTHESIS (PP) IMPLANTATION FOR ERECTILE DYSFUNCTION (ED) AND CONCURRENT PEYRONIE¿S DISEASE (PD). A CLINICIAN-DEVELOPED SURVEY TO ASSESS SATISFACTION WAS SENT TO 354 PATIENTS WHO UNDERWENT PP PLACEMENT FROM 2012¿2018 BY A SINGLE-SURGEON. RESULTS WERE COMPARED BASED ON THE PRESENCE OR ABSENCE OF CONCURRENT PD. 79 PATIENTS COMPLETED THE SURVEY (RESPONSE RATE 22%), INCLUDING 38 PATIENTS (48%) WITH CONCURRENT ED AND PD (ED/PD). MEAN FOLLOW-UP WAS 31 MONTHS (STANDARD DEVIATION 19). 87% FELT THEIR CONDITION WAS ¿VERY MUCH¿ OR ¿MUCH¿ IMPROVED. THERE WAS NO SIGNIFICANT DIFFERENCE IN PATIENT-REPORTED OVERALL SATISFACTION WITH THEIR PP OR SATISFACTION WITH CURRENT PENILE LENGTH/GIRTH BASED ON THE PRESENCE OR ABSENCE OF PD. 87% OF PATIENTS WITH PD WERE SATISFIED WITH THEIR DEGREE OF PENILE STRAIGHTENING AFTER PP PLUS OR MINUS CONCURRENT STRAIGHTENING MANEUVERS SUCH AS MODELING, PLICATION, OR INCISION/GRAFTING. SUB-GROUP ANALYSES WERE PERFORMED TO EVALUATE OUTCOMES IN THOSE WITH CONCURRENT PD/ED WHO REQUIRED PLAQUE INCI

  Patient problems: Numbness; Pain; Unspecified Infection

  MAUDE report 16512963 ↗
• InjuryFeb 27, 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 NEAR EROSION. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Erosion

  MAUDE report 16442932 ↗
• InjuryDec 14, 2022Migration; Migration

  ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE REQUIRED EXPLANTATION DUE TO CROSSOVER. AN INFLATABLE PENILE PROSTHESIS WAS IMPLANTED. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15980895 ↗
• InjuryNov 9, 2022Migration or Expulsion of Device; Migration or Expulsion of Device

  ACCORDING TO AVAILABLE INFORMATION, AN ABSTRACT TITLED, "WHICH PATIENT MAY BENEFIT THE MOST FROM PENILE PROSTHESIS IMPLANTATION?" WAS PUBLISHED IN 2022. STUDY RESULTS DO NOT APPEAR TO BE BROKEN DOWN BY PRODUCT NAME, AND SINCE THIS STUDY WAS FUNDED BY A GRANT FROM COLOPLAST AND FROM ANOTHER DEVICE MANUFACTURER, IT SEEMS THAT PRODUCTS FROM BOTH COMPANIES ARE REPRESENTED IN THIS STUDY POPULATION. POST OPERATIVE COMPLICATIONS FOR THE STUDY POPULATION, WHO WERE IMPLANTED BETWEEN DECEMBER 2014 AND NOVEMBER 2017, INCLUDED PAIN (1.1%), WOUND INFECTION (1.8%), PENOSCROTAL HEMATOMA (3.4%), FEVER (0.7%), MYOCARDIAL INFARCTION (0.4%), LOCAL ALLERGIC RUSH (0.4%), URINARY RETENTION (0.4%), DISPLACEMENT OF THE RESERVOIR (0.8%), CYLINDER EXTRUSION (0.4%), SCROTAL EXTRUSION (0.8%), URETHRAL LESION (0.4%), AND GLANS NECROSIS (0.4%). THE STUDY CONCLUDED THAT PENILE PROSTHESIS IMPLANTATION IS ASSOCIATED WITH AN OVERALL GOOD QUALITY OF LIFE. THE SUBSET OF PATIENTS AFFECTED BY ERECTILE DYSFUNCTION SECONDARY TO PEYRONIE¿S DISEASE SEEMED TO BENEFIT THE MOST FROM PENILE PROSTHESIS IMPLANTATION IN TERMS OF FUNCTIONAL OUTCOMES, RELATIONSHIP WITH THEIR PARTNERS AND THE OUTSIDE WORLD, AND PERCEIVED SELF-IMAGE.

  Patient problems: Erosion; Fever; Hematoma; Hypersensitivity/Allergic reaction; Localized Skin Lesion; Myocardial Infarction; Necrosis; Pain; Rash; Skin Erosion; Unspecified Infection; Urinary Retention

  MAUDE report 15764421 ↗

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 · Terminated
  Genesis 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