AMS Ambicor 72401451Recalls & reported problems

Summary

The FDA's MAUDE database contains 117 adverse event reports that list this exact device (DI 00878953000954), received between Jan 4, 2019 and Mar 10, 2026 — classified as 95 injuries, 22 malfunctions.

The most frequently reported specific device problem is “Inflation Problem” (48 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 117 reports, in the reporter's own words as published by the FDA.

• InjuryMar 10, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WITH THIS AMBICOR PENILE PROSTHESIS (APP) EXPERIENCED AN INFECTION, DURING WHICH THE PUMP BEGAN TO ERODE THROUGH THE SKIN. A SURGICAL INTERVENTION WAS PERFORMED, AND NO DEVICE ISSUES WERE IDENTIFIED. THE APP WAS SUBSEQUENTLY REPLACED, AND NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Erosion; Unspecified Infection

  MAUDE report 24563848 ↗
• InjuryOct 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE LOCATION OF THIS AMBICOR PENILE PROSTHESIS (APP) BECAME INFECTED, AND THE PATIENT EXPERIENCED EDEMA IN THE PENIS AND SCROTUM. PUS WAS OBSERVED IN THE PUMP AND CYLINDERS. THE CONDITION WAS TREATED WITH A FULL MULCAHY PROCEDURE AND ORAL ANTIBIOTICS. A SURGICAL PROCEDURE WAS PERFORMED IN WHICH THE IMPLANT WAS REMOVED. THERE WERE NO FURTHER PATIENT COMPLICATIONS REPORTED.

  Patient problems: Purulent Discharge; Swelling/ Edema; Unspecified Infection

  MAUDE report 23435835 ↗
• InjuryJul 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WITH THIS AMBICOR PENILE PROSTHESIS (APP) PRESENTED AND INFECTION. THE APP WAS EXPLANTED SEVERAL MONTHS AGO AND NOW WAS REPLACED WITH AN IPP. THERE IS NO ADDITIONAL INFORMATION REPORTED.

  Patient problems: Unspecified Infection

  MAUDE report 22495470 ↗
• InjuryJun 18, 2025Collapse; Fluid/Blood Leak; Inflation Problem; Collapse; Fluid/Blood Leak; Inflation Problem

  IT WAS REPORTED THAT THE CYLINDERS FROM THIS AMBICOR PENILE PROSTHESIS (APP) WERE NOT INFLATING WHEN THE PATIENT USED THE PUMP. DURING EVALUATION, THE PHYSICIAN ATTEMPTED TO INFLATE THE DEVICE AND FOUND IT WORKING PROPERLY. FLUID LOSS WAS OBSERVED IN THE DEVICE, AND THE PUMP BULB REMAINED FLAT. A SURGICAL PROCEDURE WAS PERFORMED IN WHICH THE ORIGINAL DEVICE WAS EXPLANTED AND REPLACED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22286935 ↗
• InjuryMay 27, 2025Defective Device; Defective Device

  IT WAS REPORTED THAT PATIENT WITH THIS AMBICOR PENILE PROSTHESIS (APP) WAS NOT SATISFIED WITH THE DEVICE. THE PATIENT WAS NOT SATISFIED WITH THIS APP BECAUSE IT WAS NOT RIGID ENOUGH. A SURGICAL PROCEDURE WAS PERFORMED IN WHICH THE EXISTING DEVICE WAS EXPLANTED AND REPLACED WITH AN INFLATABLE PENILE PROSTHESIS. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22090039 ↗
• InjuryFeb 27, 2025Deflation Problem; Adverse Event Without Identified Device or Use Problem; Deflation Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH AN INFECTED AMBICOR PENILE PROSTHESIS (APP), TESTICULAR PAIN, AND LEFT SUPRAPUBIC PAIN. THE PATIENT WAS UNABLE TO PROVIDE A DETAILED HISTORY AND REPORTED FALLING INTO A CHAIR AND LANDING ON HIS SCROTUM. HE ALSO REPORTED THAT IN (B)(6) 2024, HE HAD A SEVERE MOTOR VEHICLE COLLISION, RESULTING IN A TRAUMATIC BRAIN INJURY, BROKEN RIBS, A BROKEN BACK, A BROKEN NECK, AND A MEDICALLY INDUCED COMA WITH CATHETER PLACEMENT. THE PATIENT HAS NOT USED HIS APP FOR A WHILE BECAUSE HE HAS DIFFICULTY DEFLATING THE PUMP. THE PATIENT ALSO REPORTED FEVERS, CHILLS, AND INTERMITTENT HEMATURIA TWICE A WEEK. A SURGICAL PROCEDURE WAS PERFORMED TO REMOVE THE INFECTED APP, DURING WHICH A SIGNIFICANT PURULENCE WAS NOTED UPON ENTERING THE SCROTUM. AN URETHROPLASTY WAS PERFORMED TO REPAIR THE URETHRA. TWO WEEKS OF ANTIBIOTICS AND FOLEY CATHETERS WERE REQUIRED. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Chills; Fever; Hematuria; Pain; Purulent Discharge; Unspecified Infection

  MAUDE report 21477899 ↗
• InjuryNov 5, 2024Migration; Migration

  IT WAS REPORTED THAT THE PATIENT WITH THIS AMBICOR PENILE PROSTHESIS (APP) PRESENTED WITH EROSION AND CYLINDER EXTRUSION FROM THE CORPORA. IT WAS NOTED THAT THE CORPORA INCISION BROKE DOWN DUE TO POOR TISSUE QUALITY, CAUSING THE CYLINDER TO EXTRUDE SUBCUTANEOUS. A SURGICAL PROCEDURE WAS PERFORMED TO REMOVE AND REPLACE THE DEVICE IN ITS ORIGINAL LOCATION. THERE WERE NO FURTHER PATIENT COMPLICATIONS REPORTED.

  Patient problems: Erosion; Wound Dehiscence

  MAUDE report 20609630 ↗
• InjurySep 18, 2024Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT THE PATIENT WITH THIS AMBICOR PENILE PROSTHESIS (APP) PRESENTED WITH FLOPPY AND POINTY GLANS, BELIEVED TO BE DUE TO OVERSIZED CYLINDERS. A SURGICAL PROCEDURE WAS PERFORMED TO REMOVE ALL THE COMPONENTS AND IMPLANT AN INFLATABLE PENILE PROSTHESIS (IPP). THERE WERE NO FURTHER PATIENT COMPLICATIONS REPORTED.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 20246153 ↗
• InjurySep 3, 2024Inflation Problem; Adverse Event Without Identified Device or Use Problem; Inflation Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CYLINDERS OF THIS AMBICOR PENILE PROSTHESIS (APP) DID NOT INFLATE. THE APP WAS EXPLANTED AND REPLACED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20128923 ↗
• InjuryAug 27, 2024Inflation Problem; Inflation Problem

  IT WAS REPORTED BY THE PATIENT THAT HIS AMBICOR PENILE PROSTHESIS (APP) DEVICE STOPPED WORKING A COUPLE OF WEEKS EARLIER. THE PATIENT REPORTED HE HAD NOT USED THE DEVICE MUCH OVER THE LAST 10 YEARS, BUT HE WOULD LIKE TO HAVE IT REPLACED. HIS ORIGINAL DOCTOR, WHO IS NOW RETIRED, STATED THE DEVICE COULD NOT BE REPLACED DUE TO SCAR TISSUE.

  Patient problems: Scar Tissue

  MAUDE report 20082443 ↗
• InjuryAug 22, 2024Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE LEFT CYLINDER OF THE AMBICOR PENILE PROSTHESIS (APP) DEVICE WOULD NOT INFLATE. THE APP DEVICE WAS EXPLANTED, AND A NEW INFLATABLE PENILE PROSTHESIS (IPP) DEVICE WAS IMPLANTED. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20033205 ↗
• 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 THE AMBICOR PENILE PROSTHESIS CYLINDERS DID NOT INFLATE. THEREFORE, THE PATIENT UNDERWENT SURGERY TO REPLACE THE DEVICE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20029956 ↗
• MalfunctionAug 15, 2024Mechanical Problem; Adverse Event Without Identified Device or Use Problem; Mechanical Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE AMBICOR PENILE PROSTHESIS (APP) IS NO LONGER WORKING. THE APP DEVICE WAS EXPLANTED, AND A NEW APP DEVICE WAS IMPLANTED. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19992658 ↗
• InjuryAug 13, 2024Inflation 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 WITH AN AMBICOR PENILE PROSTHESIS (APP) DEVICE HAD A CYLINDER THAT DID NOT INFLATE. THE APP WAS REMOVED, AND AN AMS 700 INFLATABLE PENILE PROSTHESIS WAS IMPLANTED. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19975656 ↗
• InjuryAug 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE DISTAL TIP OF THE LEFT CYLINDER OF THE AMBICOR PENILE PROSTHESIS (APP) HAD ERODED INTO THE URETHRA. THE PHYSICIAN WAS VISUALLY ABLE TO SEE THE CYLINDER TIP WHEN HE OPENED THE PATIENT'S MEATUS. THE APP DEVICE WAS EXPLANTED, THE PATIENT'S URETHRA WAS REPAIRED, AND NEW DEVICE WAS IMPLANTED CONSISTING OF A PUMP, RESERVOIR, AND CYLINDER IN THE RIGHT CORPORA. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Erosion

  MAUDE report 19955891 ↗
• InjuryJul 24, 2024Fluid/Blood Leak; Inflation Problem; Mechanical Problem; Fluid/Blood Leak; Inflation Problem; Mechanical Problem

  IT WAS REPORTED THAT THIS AMBICOR PENILE PROSTHESIS (APP) WAS REMOVED DUE TO UNABLE TO PUMP UP DEVICE AND FLUID LOSS. A NEW TACTRA DEVICE WAS IMPLANTED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19822141 ↗
• InjuryJan 18, 2024Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT THIS AMBICOR PENILE PROSTHESIS WOULD NOT DEFLATE. THE DEVICE WAS EXPLANTED, AND THREE-PIECE INFLATABLE PENILE PROSTHESIS WAS IMPLANTED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18536146 ↗
• InjuryOct 30, 2023Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THIS AMBICOR PENILE PROSTHESIS (APP) WAS NOT WORKING. THE APP WAS EXPLANTED AND REPLACED WITH A TACTRA MALLEABLE PENILE PROSTHESIS. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18032134 ↗
• InjuryOct 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FOLLOWING THE IMPLANT OF THIS AMBICOR PENILE PROSTHESIS, THE PATIENT EXPERIENCED A SORE SPOT ON THE INSIDE OF THE VENTRAL ASPECT OF THE DISTAL PENILE SHAFT. THE ISSUE WAS NOT RESOLVED; NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Pain

  MAUDE report 17967650 ↗
• InjuryOct 13, 2023Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT THE PATIENT WAS DISSATISFIED WITH HIS AMBICOR PENILE PROSTHESIS. THE IMPLANT WAS NOT SEATED DISTALLY INTO THE GLANS. THE PATIENT UNDERWENT SURGERY AND MEASUREMENT CONFIRMED THAT THE PATIENT NEEDED A PROSTHESIS TWO CENTIMETERS LONGER. THEREFORE, THE DEVICE WAS REPLACED. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17929877 ↗
• MalfunctionOct 12, 2023Degraded; Inflation Problem; Degraded; Inflation Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH AN AMBICOR PENILE PROSTHESIS (APP) THAT WAS NO LONGER FUNCTIONING PROPERLY. THE PHYSICIAN IDENTIFIED THAT THE RIGHT CYLINDER WOULD NOT INFLATE AND THERE WAS A SMALL LUMP AT THE BASE OF THE PENIS. THE LEFT CYLINDER WAS FUNCTIONING PROPERLY. THE DEVICE HAS NOT BEEN EXPLANTED AT THIS TIME. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17922703 ↗
• InjurySep 12, 2023Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT AFTER BEING KICKED BETWEEN THE LEGS, THE PATIENT EXPERIENCED AN AMBICOR PENILE PROSTHESIS (APP) BREAK. ALTHOUGH IT WAS NOTED THE PATIENT WAS EXPERIENCING GROIN PAIN, IT WAS DETAILED THAT THE SYMPTOM WAS CAUSED BY THE KICK AND NOT THE DEVICE. A SURGICAL PROCEDURE WAS PERFORMED ON AN UNKNOWN DATE IN WHICH THE EXISTING APP WAS REMOVED. SOMETIME LATER, THE PATIENT UNDERWENT ANOTHER SURGERY IN WHICH A NEW APP WAS IMPLANTED. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17729345 ↗
• InjuryAug 2, 2023Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AMBICOR PENILE PROSTHESIS (APP) REVISION SURGERY SINCE THERE WAS FLUID LOSS THOUGH PROXIMAL PART OF THE CYLINDER DUE TO A HOLE. THE PATIENT OUTCOME WAS REPORTED TO BE FULLY RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17445538 ↗
• MalfunctionJun 15, 2023Unintended Deflation; Unintended Deflation

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED SPONTANEOUS DEFLATION WITH AN AMBICOR PENILE PROSTHESIS (APP). A REVISION WAS REQUESTED TO ADDRESS THE EXPERIENCE. NO ADDITIONAL INFORMATION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17139504 ↗
• MalfunctionJun 12, 2023Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED INFLATION ISSUES WITH AN AMBICOR PENILE PROSTHESIS (APP) LEADING TO A REVISION BEING REQUESTED. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17114130 ↗