AMS Ambicor 72401454Recalls & reported problems

Summary

The FDA's MAUDE database contains 57 adverse event reports that list this exact device (DI 00878953000985), received between Oct 24, 2018 and Sep 30, 2026 — classified as 47 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Deflation Problem” (17 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 57 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Deflation Problem

  Patient problems: Discomfort; Pain

  MAUDE report 50952826 ↗
• MalfunctionApr 21, 2026Deflation Problem

  IT WAS REPORTED THAT A PATIENT WITH AN AMBICOR PENILE PROSTHESIS (APP) STATED THAT HE WAS UNABLE TO DEFLATE THE LEFT SIDE OF THE DEVICE. THE PATIENT WAS SUGGESTED TO CONTACT HIS UROLOGIST FOR NEXT STEPS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24948320 ↗
• InjuryApr 13, 2026Deflation Problem; Inflation Problem; Nonstandard Device

  IT WAS REPORTED THAT THE PATIENT WITH THIS INFLATABLE PENILE PROSTHESIS (IPP) WAS UNABLE TO INFLATE OR DEFLATE THE DEVICE DUE TO A BLOCKED CYLINDER. A SURGICAL PROCEDURE WAS PERFORMED IN WHICH THE EXISTING DEVICE WAS EXPLANTED AND REPLACED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24859401 ↗
• InjuryJan 20, 2026Deflation Problem; Mechanical Problem; Nonstandard Device

  IT WAS REPORTED THAT THE PATIENT'S AMBICOR PENILE PROSTHESIS (APP) WAS NOT FUNCTIONING PROPERLY AS IT EXHIBITED DEFLATION ISSUES. ADDITIONALLY, THE PUMP WAS RIGID AND UNABLE TO BE PUMPED. A SURGICAL PROCEDURE WAS PERFORMED TO REMOVE THE APP, AND AT A LATER TIME, A NEW INFLATABLE PENILE PROSTHESIS (IPP) WAS IMPLANTED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24122611 ↗
• InjuryJan 6, 2026Degraded; Fluid/Blood Leak; Material Puncture/Hole

  IT WAS REPORTED THAT THE CYLINDER OF THIS AMBICOR PENILE PROSTHESIS (APP) HAD A PUNCTURE, ANEURYSM AND FLUID LOSS. AS A RESULT, THE DEVICE WAS EXPLANTED AND REPLACED WITH AN INFLATABLE PENILE PROSTHESIS (IPP). NO ADDITIONAL INFORMATION REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23981083 ↗
• InjuryDec 20, 2024Defective Device; Defective Device

  IT WAS REPORTED THAT THIS AMBICOR PENILE PROSTHESIS (APP) WOULD NOT HOLD SALINE PROPERLY. THE APP 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 20989927 ↗
• MalfunctionSep 21, 2024Defective Device; Defective Device

  IT WAS REPORTED THAT THE PATIENT IS REPORTING THAT SIX MONTHS POST IMPLANT, THE DEVICE IS NOT AS RIGID AS IT WAS PRIOR TO THE SURGERY. NO FURTHER INFORMATION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20275498 ↗
• InjurySep 12, 2024Fluid/Blood Leak; Inflation Problem; Mechanical Problem; Fluid/Blood Leak; Inflation Problem; Mechanical Problem

  IT WAS REPORTED THAT THIS AMBICOR PENILE PROSTHESIS (APP) STOPPED WORKING AS IT EXHIBITED INFLATION ISSUES AND FLUID LOSS. IMAGING TESTS WERE PERFORMED, AND A REPLACEMENT SURGERY WAS SUGGESTED. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20199932 ↗
• InjuryJun 12, 2024Deflation Problem; Deflation Problem

  IT WAS REPORTED, THAT THE AMBICOR PENILE PROSTHESIS (APP) DEVICE WAS EXPLANTED, DUE TO THE DEVICE NOT DEFLATING. A NEW APP WAS IMPLANTED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19523889 ↗
• InjuryMar 30, 2024Inflation Problem; Mechanical Problem; Adverse Event Without Identified Device or Use Problem; Inflation Problem; Mechanical Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE RIGHT CYLINDER OF THIS AMBICOR PENILE PROSTHESIS INFLATED. THE DEVICE WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19009211 ↗
• InjuryMar 25, 2024Collapse; Mechanical Problem; Collapse; Mechanical Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH THIS AMBICOR PENILE PROTHESIS THAT EXPERIENCE A FAILURE IN RIGIDITY DURING SEXUAL INTERCOURSE, THE PUMP THAT ACTIVATED THE PROSTHESIS WAS NOTICED TO BE COLLAPSED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18967635 ↗
• InjuryMar 22, 2024Adverse 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) EXPERIENCED IMPENDING EROSION ON RIGHT SIDE DISTAL PENIS. THE APP DEVICE WAS EXPLANTED AND REPLACED WITH INFLATABLE PENILE PROSTHESIS WITH A DISTAL BIOLOGICAL CAP OF ALLODERM. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Erosion

  MAUDE report 18960516 ↗
• MalfunctionOct 24, 2023Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT THIS AMBICOR PENILE PROSTHESIS DID NOT COMPLETELY DEFLATE. TROUBLESHOOTING WAS TRIED WITHOUT SUCCESS. THE PATIENT WAS INSTRUCTED TO CONTACT THE PHYSICIAN FOR FURTHER REVIEW IF THE ISSUE DID NOT RESOLVE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17999786 ↗
• InjuryAug 14, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN AMBICOR PENILE PROSTHESIS REPLACEMENT SURGERY DUE TO A LEAK IN THE RIGHT CYLINDER. THE DEVICE WAS REMOVED AND REPLACED. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17546486 ↗
• InjuryJul 11, 2023Degraded; Mechanical Problem; Degraded; Mechanical Problem

  IT WAS REPORTED THAT THIS AMBICOR PENILE PROSTHESIS HAD AN ANEURYSM IN ONE OF THE CYLINDERS, PREVENTING PROPER FUNCTIONING. BOTH CYLINDERS AND THE PUMP WERE EXPLANTED AND REPLACED WITH A NEW INFLATABLE PENILE PROSTHESIS. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17303036 ↗
• InjuryJun 14, 2023Deflation Problem; Inflation Problem; Deflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE AMBICOR PENILE PROSTHESIS (APP) CYLINDERS WERE NOT FUNCTIONAL. RIGHT SIDE INFLATED ALL THE TIME AND FAILS TO DEFLATE, LEFT SIDE DEFLATED ALL THE TIME AND UNABLE TO INFLATE. A SURGICAL PROCEDURE WAS PERFORMED IN WHICH THE APP WAS REMOVED AND REPLACED WITH A TACTRA. DURING THE PROCEDURE, IT WAS NOTICED THAT THE COLOR OF THE FLUID INSIDE THE DEVICE HAS CHANGED TO LIGHT BROWN AND THE SMELL WAS NOT NORMAL. THE DEVICE FAILED TO DEFLATE AFTER REMOVAL. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17124487 ↗
• InjuryApr 25, 2023Deflation 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 HAD THE INFLATABLE PENILE PROSTHESIS REMOVED AS IT WOULD NOT DEFLATE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16812390 ↗
• MalfunctionJan 30, 2023Degraded; Mechanical Problem; Degraded; Mechanical Problem

  IT WAS REPORTED THAT THIS AMBICOR PENILE PROSTHESIS WAS NOT FUNCTIONING AS INTENDED; PENILE DEFORMITY WAS ALSO NOTED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16269805 ↗
• InjuryJan 10, 2023Degraded; Degraded

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A CYLINDER ANEURYSM WITH AN AMBICOR PENILE PROSTHESIS (APP). A REVISION SURGERY WAS PERFORMED IN WHICH THE EXISTING APP WAS REMOVED, AND A NEW INFLATABLE PENILE PROSTHESIS (IPP) WAS IMPLANTED. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16134384 ↗
• InjuryJan 5, 2023Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED AMBICOR PENILE PROSTHESIS (APP) DEFLATION ISSUES LEADING TO A REPLACEMENT SURGERY. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16110274 ↗
• InjuryAug 30, 2022Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE PATIENT IMPLANTED WITH THIS AMBICOR PENILE PROSTHESIS (APP) HEARD A SWIRLING SOUND WHEN PUMPING THEIR DEVICE. THE FOLLOWING DAY, IT WAS NOT POSSIBLE FOR THE PATIENT TO USE THE APP. A SURGICAL PROCEDURE WAS PERFORMED DURING WHICH THE EXISTING DEVICE WAS FOUND WITH A DAMAGED TUBE AT THE SITE OF CONNECTION TO THE PUMP; A NEW APP WAS IMPLANTED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15324662 ↗
• InjuryApr 11, 2022Fluid/Blood Leak; Inflation Problem; Adverse Event Without Identified Device or Use Problem; Fluid/Blood Leak; Inflation Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A SURGICAL PROCEDURE TO EXPLANT AN AMBICOR PENILE PROSTHESIS (APP) DUE TO THE PUMP REMAINING DEFLATED. DURING THE PROCEDURE, IT WAS FOUND THAT THERE WAS NO FLUID PRESENT IN THE PUMP. A NEW APP WAS IMPLANTED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT WAS FINE POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14079531 ↗
• InjuryMar 10, 2022Defective Device; Defective Device

  IT WAS REPORTED THAT THE PATIENT WAS NOT SATISFIED WITH THE INFLATION OF THIS AMBICOR PENILE PROSTHESIS (APP), AS THEY FELT THE INFLATION WAS NOT ENOUGH, WHICH LED TO A REVISION PROCEDURE. DURING SURGERY, THE APP WAS REMOVED AND REPLACED WITH A NEW INFLATABLE PENILE PROSTHESIS. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13722781 ↗
• InjuryMar 9, 2022Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE PATIENT WAS UNABLE TO PUMP THEIR AMBICOR PENILE PROSTHESIS (APP) AND WANTED IT REPLACED WITH A MALLEABLE DEVICE. A SURGICAL PROCEDURE WAS PERFORMED DURING WHICH THE APP WAS EXPLANTED AND REPLACED WITH A TACTRA MALLEABLE DEVICE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13715114 ↗
• InjuryFeb 23, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THE PATIENT HAD THE AMBICOR PENILE PROSTHESIS REMOVED DUE TO EDEMA AND PAIN. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Pain; Swelling/ Edema

  MAUDE report 13588242 ↗