AMS Ambicor 72401450Recalls & reported problems

Summary

The FDA's MAUDE database contains 52 adverse event reports that list this exact device (DI 00878953000947), received between Oct 22, 2018 and Sep 8, 2025 — classified as 46 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Inflation Problem” (13 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, 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 52 reports, in the reporter's own words as published by the FDA.

• InjurySep 8, 2025Inflation Problem; Adverse Event Without Identified Device or Use Problem; Inflation Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT FELT HIS AMBICOR PENILE PROSTHESIS DEVICE WAS SOMETIMES AUTO INFLATING. A REVISION SURGERY WAS PERFORMED TO REPLACE THE DEVICE. AFTER EXPLANTING THE AMBICOR, THE PHYSICIAN FOUND THERE WERE NO VISIBLE MALFUNCTIONS OR ISSUES. A NEW THREE-PIECE PENILE IMPLANT DEVICE WAS IMPLANTED. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22992590 ↗
• InjuryJul 28, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT ONE OF THE CYLINDERS OF THIS AMBICOR PENILE PROSTHESIS (APP) WAS BROKEN. THE APP WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22639787 ↗
• InjuryJul 1, 2025Inflation Problem; Nonstandard Device; Defective Device; Adverse Event Without Identified Device or Use Problem; Inflation Problem; Nonstandard Device; Defective Device; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WITH THIS AMBICOR PENILE PROSTHESIS (APP) EXPERIENCED INFLATION ISSUES. DURING REMOVAL, VISIBLE DAMAGE WAS OBSERVED IN THE LEFT CYLINDER OF THE DEVICE. A SURGICAL PROCEDURE WAS PERFORMED IN WHICH THE EXISTING DEVICE WAS EXPLANTED AND REPLACED WITH AN AMS 700. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22377553 ↗
• InjuryJun 13, 2025Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT THIS AMBICOR PENILE PROSTHESIS (APP) WAS TOO SHORT, AND THE PHYSICIAN ATTEMPTED TO REPOSITION IT DURING REVISION SURGERY. DURING THE REPOSITIONING, THE DEVICE WAS DAMAGED WITH AN INSTRUMENT AND SUBSEQUENTLY EXPLANTED. A NEW INFLATABLE PENILE PROSTHESIS (IPP) WAS IMPLANTED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22202511 ↗
• InjuryJan 8, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE PATIENT WITH THIS INFLATABLE PENILE PROSTHESIS WAS DISSATISFIED SINCE IT WAS TOO HARD TO PUMP. THE DEVICE WAS REMOVED AND REPLACED WITH MALLEABLE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21099074 ↗
• InjuryOct 9, 2024Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT ONE OF THE CYLINDERS OF THIS AMBICOR PENILE PROSTHESIS (APP) EXHIBITED DEFLATION ISSUES. A SURGICAL PROCEDURE WAS PERFORMED TO REMOVE AND REPLACE THE DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20407336 ↗
• InjuryJun 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS AMBICOR PENILE PROSTHESIS (APP) WAS EXPLANTED AND REPLACED DUE TO IMPENDING EXTRUSION THROUGH THE GLANS. IT WAS ALSO REPORTED THAT THE PATIENT WAS DISSATISFIED WITH THE IMPLANT. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Erosion

  MAUDE report 19533796 ↗
• InjuryMar 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT TWO MONTHS AGO THE PATIENT WITH THIS AMBICOR PENILE PROSTHESIS (APP) EXPERIENCED AN INFECTION. A REVISION SURGERY WAS PERFORMED TO EXPLANT THE DEVICE. AFTER THE INFECTION HAS HEALED A NEW PROCEDURE HAS BEEN SCHEDULED TO PLACE A MALLEABLE DEVICE. NO DEVICE ISSUES NOR ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Unspecified Infection

  MAUDE report 18950576 ↗
• InjurySep 11, 2023Inflation Problem; Inadequacy of Device Shape and/or Size; Defective Device; Inflation Problem; Inadequacy of Device Shape and/or Size; Defective Device

  IT WAS REPORTED THAT AFTER AN AMBICOR PENILE PROSTHESIS (APP) WAS IMPLANTED, THE PATIENT EXPERIENCED GREAT FRUSTRATION AND DISSATISFACTION WITH THE RESULTS LEADING TO DISCOMFORT AND DEPRESSION. THE PATIENT INDICATED THE APP WAS INADVERTENTLY INFLATING CAUSING EMBARRASSMENT AND PAIN. ADDITIONALLY, THE PATIENT NOTED VALVE RESISTANCE WHEN TRYING TO INFLATE THE DEVICE; THESE INFLATION DIFFICULTIES ALSO LED TO PAIN DURING ACTIVATION. THE PATIENT ALLEGED THE DISTANCE BETWEEN THE CYLINDERS AND PUMP WAS TOO SHORT; THEREFORE, THE APP NEEDED TO BE ACTIVATED IN THE UPPER PART OF THE SCROTUM MAKING THE PROCESS MORE DIFFICULT. THE PATIENT INDICATED THERE WAS A BIG PORTION OF THE RIGID, PALPABLE PARTS IN THE CORPORA AND WHEN THE DEVICE WAS DEFLATED, THE PATIENT COULD NOT ACHIEVE SUFFICIENT CONCEALMENT OF THE APP. A SURGICAL PROCEDURE WAS REQUESTED TO ADDRESS THE EXPERIENCE. THERE WERE NO FURTHER PATIENT COMPLICATIONS.

  Patient problems: Depression; Discomfort; Pain

  MAUDE report 17717343 ↗
• InjuryJul 6, 2023Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT THE PATIENT HAD THE AMBICOR PENILE PROSTHESIS REMOVED AS THE IMPLANT WAS TOO LONG AND CAUSING PAIN AT THE TIP OF THE PENIS. A NEW TACTRA MALLEABLE PENILE PROSTHESIS WAS IMPLANTED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Pain

  MAUDE report 17272953 ↗
• InjuryJan 30, 2023Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT THE PATIENT HAD THE AMBICOR PENILE PROSTHESIS REMOVED DUE TO DEFLATION ISSUES. A NEW INFLATABLE PENILE PROSTHESIS WAS IMPLANTED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16269757 ↗
• InjuryOct 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A SURGICAL PROCEDURE TO EXPLANT THIS AMBICOR PENILE PROSTHESIS (APP) DUE TO INFECTION. THE INFECTION WAS CLEANED AND TREATED WITH ANTIBIOTICS. A NEW TACTRA MALLEABLE PENILE PROSTHESIS WAS IMPLANTED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: Unspecified Infection

  MAUDE report 15651469 ↗
• MalfunctionSep 14, 2022Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE PATIENT WITH THIS AMBICOR PENILE PROSTHESIS (APP) HAS BEEN UNABLE TO GET AN ERECTION SINCE THE DEVICE HAS A MECHANICAL ISSUE. A REPLACEMENT HAS BEEN REQUESTED AND THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15418653 ↗
• InjuryJul 1, 2022Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN AMBICOR PENILE PROSTHESIS (APP) SURGICAL PROCEDURE DUE TO A FLUID LEAK CAUSED BY A HOLE IN THE CYLINDER. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14882511 ↗
• MalfunctionMay 6, 2022Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT IS REQUESTING A REVISION OF AN AMBICOR PENILE PROSTHESIS (APP) DUE TO UNSPECIFIED REASONS. A PATIENT OUTCOME WAS NOT REPORTED. THE DEVICE WAS RETURNED AND ANALYSIS OF THE RETURNED DEVICE IDENTIFIED A PRODUCT MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14312363 ↗
• InjuryFeb 7, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY IN WHICH THE AMBICOR PENILE PROSTHESIS (APP) WAS REMOVED AND REPLACED WITH AN INFLATABLE PENILE PROSTHESIS (IPP) DUE TO A FLUID LEAK FROM AN UNIDENTIFIED ORIGIN. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13472331 ↗
• InjuryFeb 1, 2022Fluid/Blood Leak; Mechanical Problem; Material Puncture/Hole; Fluid/Blood Leak; Mechanical Problem; Material Puncture/Hole

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN AMBICOR PENILE PROSTHESIS (APP) REPLACEMENT SURGERY DUE TO THE DEVICE NOT WORKING. DURING THE INTERVENTION, FLUID LOSS WAS NOTED DUE TO A HOLE IN THE CYLINDER. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13418697 ↗
• MalfunctionJan 18, 2022Inflation Problem; Mechanical Problem; Inflation Problem; Mechanical Problem

  IT WAS REPORTED THAT A REVISION WAS REQUESTED FOR AN AMBICOR PENILE PROSTHESIS (APP) DUE TO INFLATION ISSUES; HOWEVER, THE SURGERY HAS NOT BEEN PERFORMED YET. THERE WERE NO ADVERSE EVENTS TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13285454 ↗
• InjuryDec 21, 2021Mechanical Problem; Adverse Event Without Identified Device or Use Problem; Mechanical Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PHYSICIAN REQUESTED AN AMBICOR PENILE PROSTHESIS (APP) REVISION SURGERY DUE TO THE PATIENT COULD NOT USE THE PROSTHESIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13052529 ↗
• InjuryAug 12, 2021Deflation Problem; Fluid/Blood Leak; Defective Device; Deflation Problem; Fluid/Blood Leak; Defective Device

  IT WAS REPORTED THAT THE PATIENT COMPLAINED THAT HIS AMBICOR PENILE PROSTHESIS (APP) WAS NOT RIGID ENOUGH AND EXHIBITED DEFLATION ISSUES. A REPLACEMENT SURGERY WAS PERFORMED AND A LEAK IN THE CYLINDERS WAS IDENTIFIED. THERE WERE NO PATIENT COMPLICATIONS IN RELATION WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12315412 ↗
• InjuryAug 12, 2021Contamination; Inflation Problem; Mechanical Problem; Contamination; Inflation Problem; Mechanical Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED MECHANICAL ISSUES WITH THIS AMBICOR PENILE PROSTHESIS (APP) RELATED WITH DEVICE INFLATION DUE TO STIFF AND DIFFICULT TO MANIPULATE PUMP. A SURGICAL PROCEDURE WAS PERFORMED, IN WHICH THE PHYSICIAN STARTED BY TROUBLESHOOTING THE DEVICE WHILE PATIENT WAS UNDER ANESTHESIA, HOWEVER, THE ISSUES PERSISTED. ALL COMPONENTS OF THE EXISTING APP WERE EXPLANTED AND REPLACED WITH A NEW APP. UPON INSPECTION OF THE EXPLANTED DEVICE, TISSUE WAS FOUND INSIDE THE PUMP. THE PHYSICIAN CONSIDERS THAT THIS FOREIGN MATERIAL COULD HAVE ENTERED THE SYSTEM IN A PREVIOUS SURGERY, WHEN ONE OF THE CYLINDERS WAS REPLACED. NO ADDITIONAL INFORMATION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12315284 ↗
• InjuryMay 26, 2021Inflation Problem; Mechanical Problem; Inflation Problem; Mechanical Problem

  IT WAS REPORTED THAT A PHYSICIAN REQUESTED A REVISION FOR AN AMBICOR PENILE PROSTHESIS (APP) DUE TO THE DEVICE NOT INFLATING. THERE WERE NO PATIENT SYMPTOMS OR ADVERSE EVENTS. IT WAS UNKNOWN WHETHER THERE WERE ANY SPECIFIC DEVICE MALFUNCTIONS CAUSING THE DEVICE NOT TO INFLATE. THE SURGICAL PROCEDURE HAD NOT BEEN SCHEDULED YET.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11887031 ↗
• InjuryMay 21, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE AMBICOR PENILE PROSTHESIS (APP) DEVICE HAD FLUID LOSS. THE PATIENT UNDERWENT A SURGICAL PROCEDURE IN WHICH HIS APP WAS EXPLANTED AND A NEW INFLATABLE PENILE PROSTHESIS (IPP) WAS IMPLANTED. THE PATIENT REMAINS STABLE AFTER THE PROCEDURE.

  Patient problems: Insufficient Information

  MAUDE report 11867462 ↗
• InjuryMay 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT SURGICAL PROCEDURE TO REVISE THIS AMBICOR PENILE PROSTHESIS (APP) DUE TO AN INFECTION, FEVER, AND LOCAL PAIN. THE APP WAS EXPLANTED AND REPLACED WITH A NEW APP. FOLLOWING THE PROCEDURE THE PATIENT WAS OK.

  Patient problems: Fever; Pain; Unspecified Infection

  MAUDE report 11841316 ↗
• MalfunctionMay 4, 2021Inflation Problem; Mechanical Problem; Inflation Problem; Mechanical Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED INFLATION ISSUES WITH AN AMBICOR PENILE PROSTHESIS (APP) LEADING TO A REVISION BEING REQUESTED; HOWEVER, THE PROCEDURE HAD NOT BEEN SCHEDULED YET.

  Patient problems: Insufficient Information

  MAUDE report 11769284 ↗