AMS Ambicor 72401452Recalls & reported problems

Summary

The FDA's MAUDE database contains 153 adverse event reports that list this exact device (DI 00878953000961), received between Oct 5, 2018 and Sep 4, 2026 — classified as 136 injuries, 17 malfunctions.

The most frequently reported specific device problem is “Inflation Problem” (58 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 153 reports, in the reporter's own words as published by the FDA.

• InjurySep 4, 2026Inadequacy of Device Shape and/or Size

  It was reported that the patient experienced floppy glans and stated that the Ambicor Penile Prosthesis (APP) was not long enough. A revision procedure was performed during which the APP was explanted, the patient was re-sized, and a 21 cm CX device was implanted. No additional patient complications were reported.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 50602253 ↗
• InjuryMay 19, 2026Mechanical Problem

  IT WAS REPORTED THAT THE PATIENT'S AMBICOR PENILE PROSTHESIS (APP) WAS NOT FUNCTIONING AS INTENDED. A SURGICAL PROCEDURE WAS SUBSEQUENTLY PERFORMED, DURING WHICH THE APP WAS EXPLANTED AND REPLACED WITH AN INFLATABLE PENILE PROSTHESIS (IPP). NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25224924 ↗
• InjuryFeb 26, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WITH AN AMBICOR PENILE PROSTHESIS (APP) EXPERIENCED PAIN AND DEVELOPED A SCROTAL INFECTION. UPON INSPECTION, PUS WAS OBSERVED AND CULTURES WERE SENT FOR PATHOLOGY. A SURGICAL PROCEDURE WAS PERFORMED TO REMOVE THE APP AND REPLACE IT WITH A TACTRA MALLEABLE DEVICE. HOWEVER, DURING CLOSURE, A URETHRAL INJURY WAS IDENTIFIED, UNRELATED TO THE DEVICE, PROMPTING THE PHYSICIAN TO REMOVE THE TACTRA DEVICE WITHOUT PLACING A NEW IMPLANT. THE INFECTION WAS TREATED WITH ANTIBIOTICS. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Pain; Purulent Discharge; Unspecified Infection

  MAUDE report 24464148 ↗
• InjuryFeb 4, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WITH THIS AMBICOR PENILE PROSTHESIS (APP) DEVELOPED AN INFECTION IN THE SCROTUM. A SURGICAL PROCEDURE WAS PERFORMED TO REMOVE THE APP, AND A TACTRA DEVICE WAS TEMPORARILY IMPLANTED; INFECTION WAS TREATED WITH ANTIBIOTICS. SEVERAL MONTHS LATER, AFTER THE INFECTION RESOLVED, THE TACTRA WAS REPLACED WITH A THREE-PIECE DEVICE. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Unspecified Infection

  MAUDE report 24259404 ↗
• InjuryJan 8, 2026Inflation Problem; Nonstandard Device

  IT WAS REPORTED THAT THIS AMBICOR PENILE PROSTHESIS (APP) WAS NOT INFLATING PROPERLY, AND THE PATIENT EXPRESSED DISSATISFACTION WITH THE DEVICE. A SURGICAL PROCEDURE WAS PERFORMED IN WHICH THE AMBICOR IMPLANT WAS REMOVED AND REPLACED WITH AN INFLATABLE PENILE PROSTHESIS (IPP). THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24007102 ↗
• InjuryDec 29, 2025Inflation Problem; Mechanical Problem; Nonstandard Device; Inflation Problem; Mechanical Problem; Nonstandard Device

  IT WAS REPORTED THAT A PATIENT WITH AN AMBICOR PENILE PROSTHESIS (APP) PRESENTED WITH A NONFUNCTIONING DEVICE. A REVISION SURGERY WAS PERFORMED, DURING WHICH THE PHYSICIAN EXPLANTED THE DEVICE AND REPLACED IT WITH AN INFLATABLE PENILE PROSTHESIS (IPP). NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23916958 ↗
• InjuryDec 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WITH AN AMBICOR PENILE PROSTHESIS (APP) DEVELOPED AN INFECTION IN THE SCROTUM, AND OOZING OF BODILY FLUIDS WAS OBSERVED. A SURGICAL PROCEDURE WAS PERFORMED TO REMOVE THE APP, FOLLOWED BY A COMPLETE WASHOUT WITH ANTIBIOTICS. A NEW TACTRA DEVICE WAS IMPLANTED. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Purulent Discharge; Unspecified Infection

  MAUDE report 23775414 ↗
• MalfunctionSep 19, 2025Deflation Problem; Inflation Problem; Deflation Problem; Inflation Problem

  IT WAS REPORTED THAT THIS AMBICOR PENILE PROSTHESIS (APP) EXPERIENCED LOSS OF RIGIDITY, THE MECHANISM IS NOT WORKING, AND THE DEVICE DOES NOT DEFLATE COMPLETELY. A REPLACEMENT SURGERY HAS BEEN SCHEDULED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23101542 ↗
• InjuryAug 5, 2025Deflation Problem; Degraded; Mechanical Problem; Deflation Problem; Degraded; Mechanical Problem

  IT WAS REPORTED THAT THE AMBICOR PENILE PROSTHESIS (APP) HAD DEFLATION ISSUES AND DID NOT CYCLE. EXAMINATION REVEALED A BULGE IN THE CYLINDER. CONSEQUENTLY, THE DEVICE WAS EXPLANTED. NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22722651 ↗
• InjuryJul 31, 2025Fluid/Blood Leak; Inflation Problem; Fluid/Blood Leak; Inflation Problem

  IT WAS REPORTED THAT A PATIENT WITH AN AMBICOR PENILE PROSTHESIS APP PRESENTED WITH DEVICE NO LONGER INFLATING. A REVISION SURGERY WAS PERFORMED, DURING WHICH THE PHYSICIAN CONFIRMED THAT DEVICE NO LONGER INFLATING WAS SECONDARY TO FLUID LOSS IN THE SYSTEM. THE DEVICE WAS EXPLANTED. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22683128 ↗
• InjuryJun 25, 2025Deflation Problem; Inflation Problem; Unintended Deflation; Deflation Problem; Inflation Problem; Unintended Deflation

  IT WAS REPORTED THAT THE PATIENT WAS DISSATISFIED WITH THIS AMBICOR PENILE PROSTHESIS (APP), PATIENT FELT DEVICE WAS NOT GETTING FULLY ERECT AND DEFLATING COMPLETELY. A SURGICAL PROCEDURE WAS PERFORMED TO REMOVE THE APP AND REPLACE WITH AN INFLATABLE PENILE PROSTHESIS (IPP). NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22331168 ↗
• InjuryMay 8, 2025Fluid/Blood Leak; Inflation Problem; Material Puncture/Hole; Fluid/Blood Leak; Inflation Problem; Material Puncture/Hole

  IT WAS REPORTED THAT THIS AMBICOR PENILE PROSTHESIS (APP) WAS NOT FULLY INFLATING. ONCE THE DEVICE WAS REMOVED, THE PUMP WAS TESTED, AND A FLUID LEAK WAS IDENTIFIED FROM A HOLE IN THE THE TUBING OF THE PUMP TO THE CYLINDER. THE APP WAS EXPLANTED. NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21987564 ↗
• InjuryMar 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT STATED HE WAS EXPERIENCING SIGNIFICANT PAIN FROM HIS RECENT AMBICOR PENILE PROSTHESIS (APP) IMPLANT AND HAD DIFFICULTY WALKING DUE TO THE PAIN IN THE SCROTUM. DURING A SURGICAL PROCEDURE, THE PHYSICIAN IDENTIFIED A SUBSTANTIAL AMOUNT OF PUS AND SIGNS OF INFECTION IN THE SCROTUM. CONSEQUENTLY, A WASHOUT WAS PERFORMED, AND THE OLD APP WAS REMOVED. HOWEVER, AN ATTEMPT TO IMPLANT A NEW MALLEABLE DEVICE WAS UNSUCCESSFUL DUE TO EXTENSIVE TISSUE DAMAGE FROM THE PATIENT'S POOR HEALTH CONDITION. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Pain; Purulent Discharge; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 21698059 ↗
• InjuryMar 21, 2025Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT THE AMBICOR PENILE PROSTHESIS (APP) WAS NOT DEFLATING. A SURGICAL PROCEDURE WAS PERFORMED TO REPLACE THE SYSTEM. THERE WERE NO FURTHER PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21663459 ↗
• InjuryJan 30, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE PATIENT WITH THIS AMBICOR PENILE PROSTHESIS (APP) COULD NOT PUMP UP THE IMPLANT. THE APP WAS EXPLANTED AND REPLACED WITH A THREE-PIECE IMPLANT. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21277035 ↗
• InjuryDec 23, 2024Inflation Problem; Mechanical Problem; Air/Gas in Device; Inflation Problem; Mechanical Problem; Air/Gas in Device

  IT WAS REPORTED THAT THE PATIENT WITH THIS AMBICOR PENILE PROSTHESIS (APP) EXPERIENCED BOTH URINARY INCONTINENCE AND URINARY OBSTRUCTION AT THE SAME TIME. IN ADDITION, THE PATIENT STATED THAT THE APP WAS NOT WORKING PROPERLY AS IT HAS LOST ITS RIGIDITY AND WAS NOT INFLATING COMPLETELY. A COMPUTED TOMOGRAPHY WAS PERFORMED, DURING WHICH AIR WITHIN THE SYSTEM WAS NOTED; WHICH THE PHYSICIAN SUSPECTS COULD BE THE CAUSE OF THE URINARY OBSTRUCTION; THEREFORE, THE EXISTING APP WAS REMOVED AND REPLACED WITH A TACTRA MALLEABLE DEVICE. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Obstruction/Occlusion; Urinary Incontinence

  MAUDE report 21000057 ↗
• InjuryDec 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, FOLLOWING THIS AMBICOR PENILE PROSTHESIS (APP) IMPLANT PROCEDURE, AN ATTEMPT WAS MADE TO REMOVE THE PROBE, BUT IT WAS UNSUCCESSFUL. AS A RESULT, THE PATIENT WAS DISCHARGED WITH INSTRUCTIONS THAT IT SHOULD NATURALLY COME OUT WITHIN A DAY OR TWO; HOWEVER, THIS DID NOT OCCUR, LEADING TO INFLAMMATION AND INFECTION. SURGICAL INTERVENTION WAS REQUIRED TO REMOVE THE PROBE, FOLLOWED BY AN ADDITIONAL PROCEDURE TO PERFORM A WASHOUT. NO FURTHER INFORMATION WAS REPORTED.

  Patient problems: Inflammation; Unspecified Infection

  MAUDE report 20904314 ↗
• InjuryDec 11, 2024Fluid/Blood Leak; Mechanical Problem; Material Puncture/Hole; Fluid/Blood Leak; Mechanical Problem; Material Puncture/Hole

  IT WAS REPORTED THAT THIS AMBICOR PENILE PROSTHESIS (APP) STOPPED WORKING DUE TO A BROKEN TUBING AND FLUID LOSS. A SURGICAL PROCEDURE WAS PERFORMED TO REMOVE AND REPLACE THE DEVICE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20903278 ↗
• InjuryDec 2, 2024Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT THIS AMBICOR PENILE PROSTHESIS (APP) HAD DEFLATION ISSUES. THE APP WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20824094 ↗
• InjuryOct 31, 2024Fluid/Blood Leak; Inflation Problem; Defective Device; Air/Gas in Device; Fluid/Blood Leak; Inflation Problem; Defective Device; Air/Gas in Device

  IT WAS REPORTED THAT THIS AMBICOR PENILE PROSTHESIS (APP) RIGHT CYLINDER WAS NOT INFLATING. THE CYLINDER WAS WORN, A FLUID LEAK WAS IDENTIFIED, AND AIR WAS PRESENT IN THE SYSTEM, WHICH MADE IT UNABLE TO PROPERLY PUMP. THE APP WAS EXPLANTED AND REPLACED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20579129 ↗
• InjuryOct 18, 2024Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE PATIENT HAS NOT BEING ABLE TO PUMP THIS AMBICOR PENILE PROSTHESIS (APP) FOR THE PAST FOUR YEARS, RESULTING IN A SEMIRIGID ERECTION. A SURGICAL PROCEDURE WAS PERFORMED TO REMOVE THE DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20481141 ↗
• InjuryAug 23, 2024Inflation Problem; Mechanical Problem; Failure to Deflate; Inflation Problem; Mechanical Problem; Failure to Deflate

  IT WAS REPORTED THAT THE PATIENT IS EXPERIENCING DIFFICULTIES INFLATING AND DEFLATING HIS AMBICOR PENILE PROSTHESIS. THE PATIENT STATED THAT THE PUMP IS HARD AS A ROCK AND FLUID DOES NOT SEEM TO TRANSFER IN OR OUT OF THE CYLINDERS, THE PATIENT FEELS THAT THE PROSTHESIS IS ALWAYS AT APPROXIMATELY 50% INFLATION. THE PATIENT HAS SCROTAL PAIN. THE PATIENT WAS EVALUATED BY HIS PHYSICIAN, WHO CONFIRMED THE DEVICE OPERATION DIFFICULTY, BUT SUGGESTED TO WAIT TWO OR THREE WEEKS, HOPING IT WILL RESOLVE. BOSTON SCIENTIFIC PATIENT SERVICES SPECIALIST SUGGESTED TO ATTEMPT IN THE SHOWER, WHICH HE ALREADY DID. THE PATIENT WANTS TO GET A SECOND OPINION FROM ANOTHER DOCTOR.

  Patient problems: Pain

  MAUDE report 20055570 ↗
• InjuryAug 23, 2024Inflation Problem; Adverse Event Without Identified Device or Use Problem; Inflation Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS AMBICOR PENILE PROSTHESIS (APP) CYLINDER DID NOT INFLATE AS INTENDED. THE APP WAS REPLACED WITH A NEW INFLATABLE PENILE PROSTHESIS (IPP) DEVICE. THERE WAS NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20050889 ↗
• InjuryAug 22, 2024Inflation Problem; Adverse Event Without Identified Device or Use Problem; Inflation Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ONE OF THE CYLINDERS OF THIS AMBICOR PENILE PROSTHESIS (APP) EXHIBITED INFLATION ISSUES. A SURGICAL PROCEDURE WAS PERFORMED, DURING WHICH THE APP WAS REMOVED, AND AN INFLATABLE PENILE PROSTHESIS (IPP) WAS IMPLANTED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20034124 ↗
• InjuryAug 21, 2024Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE CYLINDERS OF THE AMBICOR PENILE PROSTHESIS DID NOT INFLATE. THE PATIENT UNDERWENT SURGERY TO REPLACE THE DEVICE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20010693 ↗