AMS Ambicor 72401453Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 00878953000978), received between Nov 8, 2018 and Jun 30, 2026 — classified as 22 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Inflation Problem” (7 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 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• InjuryJun 30, 2026Inflation Problem; Unintended Deflation

  IT WAS REPORTED THAT THE PATIENT'S AMBICOR PENILE PROSTHESIS (APP) WAS NOT FUNCTIONING PROPERLY, THE DEVICE EXHIBITED INFLATION ISSUES AND SPONTANEOUS DEFLATION. A SURGICAL PROCEDURE WAS PERFORMED DURING WHICH THE APP WAS REMOVED AND REPLACED WITH AN INFLATABLE PENILE PROSTHESIS (IPP). THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25673575 ↗
• InjuryJun 30, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A PATIENT WITH AN AMBICOR PENILE PROSTHESIS APP PRESENTED WITH FLUID LOSS IN THE SYSTEM. A REVISION SURGERY WAS PERFORMED, DURING WHICH THE PHYSICIAN CONFIRMED FLUID LOSS IN THE DISTAL RIGHT CYLINDER. THE DEVICE WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22366485 ↗
• InjuryMay 30, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH A NON WORKING AMBICOR PENILE PROSTHESIS DEVICE. THE PHYSICIAN CONFIRMED THAT THE PATIENT WAS NO LONGER ABLE TO INFLATE OR DEFLATE THE DEVICE. THE DEVICE WAS EXPLANTED AND REPLACED. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22117191 ↗
• InjuryFeb 4, 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) EXPERIENCED AN INFECTION. THE APP WAS PREVIOUSLY EXPLANTED. THE PATIENT HEALED, AND A NEW DEVICE WAS PLACED. THERE WERE NO FURTHER PATIENT COMPLICATIONS.

  Patient problems: Unspecified Infection

  MAUDE report 21303453 ↗
• InjuryJan 17, 2025Inflation Problem; Failure to Deflate; Inflation Problem; Failure to Deflate

  IT WAS REPORTED THAT THIS AMBICOR PENILE PROSTHESIS (APP) WAS DIFFICULT TO INFLATE AND DEFLATE. THE DEVICE WAS NOT WORKING PROPERLY. THE APP WAS EXPLANTED AND REPLACED WITH AN INFLATABLE PENILE PROSTHESIS (IPP). THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21182733 ↗
• InjuryAug 7, 2024Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THIS AMBICOR PENILE PROSTHESIS WOULD NOT STAY INFLATED. ALL THE COMPONENTS WERE REMOVED AND REPLACED WITH A 3-PIECE INFLATABLE PENILE PROSTHESIS. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19935001 ↗
• InjuryMay 6, 2024Fluid/Blood Leak; Inflation Problem; Fluid/Blood Leak; Inflation Problem

  IT WAS REPORTED THAT THIS AMBICOR PENILE PROSTHESIS WAS NOT FULLY INFLATING DUE TO FLUID LOSS. 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 19256554 ↗
• InjuryNov 29, 2023Inflation Problem; Mechanical Problem; Inflation Problem; Mechanical Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH AN AMBICOR PENILE PROSTHESIS (APP) THAT WAS NOT FUNCTIONING PROPERLY FOR ALMOST A YEAR. THE IMPLANT WOULD NO LONGER INFLATE, AND THE PATIENT COULD NOT ACHIEVE AN ERECTION. THE PATIENT UNDERWENT SURGICAL INTERVENTION TO EXPLANT THE APP AND REPLACE WITH A NEW DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18234360 ↗
• InjuryNov 13, 2023Deflation Problem; Degraded; Deflation Problem; Degraded

  IT WAS REPORTED THAT THE PATIENT UNDERWENT SURGICAL INTERVENTION TO EXPLANT THE AMBICOR PENILE PROSTHESIS (APP) DUE TO DIFFICULTIES DEFLATING THE IPP. ONE CYLINDER WAS STAYING INFLATED AT ALL TIMES RESULTING IN PAIN AND DISCOMFORT, IN THE PENIS SHAFT, FOR THE PATIENT. IMAGING WAS PERFORMED AND A BULGE WAS IDENTIFIED ON THE CYLINDER. A NEW AMBICOR PENILE PROSTHESIS (APP) WAS IMPLANTED. THERE WERE NO ADDITIONAL PATIENT COMPLICATIONS REPORTED.

  Patient problems: Discomfort; Pain

  MAUDE report 18121684 ↗
• MalfunctionOct 24, 2023Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT THE PATIENT WITH THIS AMBICOR PENILE PROSTHESIS (APP) EXPERIENCED DEFLATION ISSUES. NO PATIENT COMPLICATIONS WERE REPORTED. A REVISION SURGERY HAS BEEN SCHEDULED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17999638 ↗
• InjuryOct 9, 2023Mechanical Problem; Material Puncture/Hole; Mechanical Problem; Material Puncture/Hole

  IT WAS REPORTED THAT THE PATIENT STATED THAT THIS AMBICOR PENILE PROSTHESIS (APP) WAS NOT WORKING PROPERLY. FOUR DAYS LATER, A SURGICAL PROCEDURE WAS PERFORMED TO REMOVE AND REPLACE ALL THE COMPONENTS. UPON EXPLANT, A BREAK IN THE CYLINDER WAS IDENTIFIED. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17897672 ↗
• InjuryApr 11, 2023Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE AMBICOR PENILE PROSTHESIS (APP) WAS MALFUNCTIONING AND WAS REPLACED. THE DEVICE WAS REPLACED WITH AN INFLATABLE PENILE PROSTHESIS (IPP). THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16718052 ↗
• InjuryMar 30, 2023Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT THE PATIENT HAD THE AMBICOR PENILE PROSTHESIS REMOVED AS THE DEVICE WOULD NOT DEFLATE. A NEW AMBICOR PENILE PROSTHESIS WAS IMPLANTED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16649497 ↗
• InjuryJun 15, 2022Migration; Migration

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN AMBICOR PENILE PROSTHESIS (APP) REPLACEMENT SURGERY DUE TO THE DEVICE MIGRATION FROM THE SHAFT INTO THE BODY; ACCORDING TO THE FIELD REPRESENTATIVE, THIS WAS LIKELY CAUSED BY PATIENT'S ANATOMY. A NEW APP WAS IMPLANTED AND NO FURTHER INFORMATION HAS BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14707556 ↗
• InjuryMay 13, 2022Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE AMBICOR PENILE PROSTHESIS (APP) STOPPED WORKING; THEREFORE, THE PATIENT UNDERWENT A SURGICAL PROCEDURE TO EXPLANT THE APP. ALL COMPONENTS OF THE EXISTING APP WERE EXPLANTED AND REPLACED WITH A NEW APP. THE PATIENT IS DOING WELL POST REPLACEMENT PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14400440 ↗
• InjuryFeb 23, 2022Fluid/Blood Leak; Mechanical Problem; Fluid/Blood Leak; Mechanical Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN AMBICOR PENILE PROSTHESIS (APP) REPLACEMENT SURGERY DUE TO FLUID LOSS FROM AN UNIDENTIFIED SOURCE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13587634 ↗
• InjurySep 9, 2021Deflation Problem; Degraded; Mechanical Problem; Deflation Problem; Degraded; Mechanical Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A SURGICAL PROCEDURE TO REMOVE THIS AMBICOR PENILE PROSTHESIS (APP) SYSTEM IN WHICH AN ANEURYSM IN THE LEFT CYLINDER HAD STOPPED THE DEVICE FROM DEFLATING. IT WAS REPLACED BY AN INFLATABLE PENILE PROSTHESIS (IPP) SYSTEM. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12447555 ↗
• InjuryJul 27, 2021Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A SURGICAL PROCEDURE TO REVISE THIS AMBICOR PENILE PROSTHESIS (APP) DUE TO DEFLATION ISSUES. THE APP WAS EXPLANTED AND REPLACED WITH A NEW APP WITH NO CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12234524 ↗
• InjuryFeb 4, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A SURGICAL PROCEDURE TO REVISE THIS AMBICOR PENILE PROSTHESIS (APP) DUE TO PAIN. THE PHYSICIAN OBSERVED THE DEVICE WAS ERODING OUT OF THE PENIS. THE APP WAS EXPLANTED AND NO NEW DEVICE WAS IMPLANTED. THE PATIENT FULLY RECOVERED FOLLOWING THE PROCEDURE.

  Patient problems: Erosion; Pain

  MAUDE report 11282610 ↗
• InjuryOct 30, 2019Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN AMBICOR PENILE PROSTHESIS (APP) REPLACEMENT SURGERY BECAUSE TO THE RIGHT CYLINDER WOULD NOT INFLATE DUE TO A FLUID LEAK. THE SYSTEM WAS REMOVED AND A NEW APP WAS IMPLANTED. THERE WERE NO FURTHER PATIENT COMPLICATIONS IN RELATION TO THIS EVENT. NO MORE INFORMATION IS AVAILABLE AT THE MOMENT, ADDITIONAL INFORMATION WAS REQUESTED AND WILL BE PROVIDED AS RELEVANT INFORMATION BECOMES AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9254971 ↗
• MalfunctionOct 29, 2019Defective Device; Defective Device

  IT WAS REPORTED THAT PATIENT LIAISON SPOKE WITH PATIENT WHO HAD AN AMBICOR PENILE PROSTHESIS (APP) IMPLANTED 3 MONTHS AGO. HE HAS BEEN UNHAPPY SINCE THE IMPLANT FOR TWO MAIN REASONS: HE SAYS IT SHANKS SO SEVERELY TO THE LEFT THAT WHEN HE URINATES, IF HE DOES NOT CONTROL IT, HE PEES ALL OVER. IT DOES NOT MEASURE WHAT HE DID WHEN HE USED THE VACUUM PUMP PRIOR TO SURGERY. PATIENT LIAISON EXPLAINED HIM THAT THE PUMP PULLED BLOOD FLOW INTO AREAS THAT OUR DEVICE DOES NOT ADDRESS AND THAT COULD BE THE SIZE DIFFERENCE THAT HE IS NOTICING. HE ASKED FOR ASSISTANCE IN FINDING A DOCTOR FOR A SECOND OPINION; PATIENT LIAISON GAVE HIM THE TWO NAMES THAT POPULATED ON (B)(6) THAT WERE CLOSEST TO HIS ZIP CODE. HE REQUESTED TO SPEAK WITH THE REP. AND PATIENT LIAISON SENT THE INFORMATION TO THE BSC REP. ADDITIONAL INFORMATION WAS REQUESTED, HOWEVER NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9249598 ↗
• InjuryMay 30, 2019Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT DUE TO THE CYLINDERS NO LONGER INFLATING THE PATIENT HAD HIS AMBICOR PENILE PROSTHESIS (APP) REMOVED AND REPLACED. THE INFLATION ISSUES STARTED A FEW MONTHS PRIOR TO THIS SURGERY. DURING THIS SURGERY THE PHYSICIAN WAS UNABLE TO IDENTIFY THE REASON FOR THE INFLATION ISSUES. THE APP WAS EXPLANTED AND A NEW DEVICE CONSISTING OF A 20CMX14MM CYLINDERS AND PUMP WERE IMPLANTED. THE NEW AMBICOR WAS FUNCTIONING AS IT SHOULD FOLLOWING THIS REPLACEMENT SURGERY. SHOULD ADDITIONAL INFORMATION BE RECEIVED A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8655896 ↗
• InjuryMar 6, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED UNSPECIFIED ISSUES WITH AN AMBICRO PENILE PROSTHESIS (APP). THE APP WAS EXPLANTED AND A NEW 15CM INFLATABLE PENILE PROSTHESIS (IPP) WAS IMPLANTED. FURTHER INFORMATION HAS BEEN REQUESTED AND NOT YET RECEIVED. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE OR THE PRODUCT WAS RETURNED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF PRODUCT ANALYSIS. ADDITIONAL INFORMATION WAS REPORTED THAT THE AMBICOR WAS EXPLANTED PRIOR TO THE NEW IPP IMPLANT AND THE PATIENT DID NOT HAVE ANY DEVICE IMPLANTED AT TIME OF REVISION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8396728 ↗
• InjuryNov 8, 2018Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE PATIENT HAD THE AMBICOR PENILE PROSTHESIS REMOVED AS THE RIGIDITY HAD CHANGED SO THAT IT DID NOT REMAIN RIGID OVER TIME. A NEW 14MM X 18CM AMS AMBICOR PENILE PROSTHESIS WAS IMPLANTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8052998 ↗