AMS Ambicor 72401455Recalls & reported problems

Summary

The FDA's MAUDE database contains 75 adverse event reports that list this exact device (DI 00878953000992), received between Dec 18, 2018 and Nov 19, 2025 — classified as 57 injuries, 18 malfunctions.

The most frequently reported specific device problem is “Inflation Problem” (29 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 75 reports, in the reporter's own words as published by the FDA.

• InjuryNov 19, 2025Degraded; Inflation Problem; Malposition of Device; Degraded; Inflation Problem; Malposition of Device

  IT WAS REPORTED THAT THE PATIENT WITH AN AMBICOR PENILE PROSTHESIS (APP) EXPERIENCED PAIN IN THE REGION OF THE PROSTHESIS. A CYSTOSCOPY WAS PERFORMED, REVEALING THAT THE DEVICE WAS NOT PROPERLY DEPLOYED, WAS NOT FUNCTIONING CORRECTLY, AND SHOWED DILATION AT THE BASE OF THE PENIS. THE DEVICE REMAINS IMPLANTED, AND A REVISION SURGERY IS PLANNED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED.

  Patient problems: Pain

  MAUDE report 23598483 ↗
• MalfunctionNov 10, 2025Degraded; Fluid/Blood Leak; Mechanical Problem; Material Puncture/Hole; Degraded; Fluid/Blood Leak; Mechanical Problem; Material Puncture/Hole

  IT WAS REPORTED THAT THIS AMBICOR PENILE PROSTHESIS (APP) PRESENTED A MECHANICAL PROBLEM, SHOWING A DILATION AT THE BASE. IT WAS REPORTED A FLUID LOSS DUE TO A PERFORATION OR AN ANEURYSM. THE APP IS CURRENTLY IMPLANTED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23513516 ↗
• InjuryNov 4, 2025Fluid/Blood Leak; Inflation Problem; Mechanical Problem; Nonstandard Device; Fluid/Blood Leak; Inflation Problem; Mechanical Problem; Nonstandard Device

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH HIS AMBICOR PENILE PROSTHESIS (APP) DEVICE NOT INFLATING. PELVIC AND PENIS MAGNETIC RESONANCE IMAGING (MRI) WAS PERFORMED WHICH CONFIRMED THERE WAS A MECHANICAL ISSUE WITH THE PUMP. THE PHYSICIAN SUSPECTED THE DEVICE NOT FUNCTIONING WAS DUE TO FLUID LOSS FROM THE DEVICE. THE APP 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 23463996 ↗
• MalfunctionMar 26, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THIS AMBICOR PENILE PROSTHESIS (APP) IS DEFECTIVE. NO REVISION SURGERY HAS BEEN INFORMED, AND NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21699622 ↗
• InjuryFeb 6, 2025Inflation Problem; Mechanical Problem; Defective Device; Inflation Problem; Mechanical Problem; Defective Device

  IT WAS REPORTED THAT THIS AMBICOR PENILE PROSTHESIS (APP) STOPPED WORKING DUE TO INFLATION ISSUES AND THE PUMP NOT REFILLING. A SURGICAL PROCEDURE WAS PERFORMED TO REMOVE THE APP AND IMPLANT A NEW INFLATABLE PENILE PROSTHESIS (IPP). NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21321637 ↗
• MalfunctionJan 9, 2025Inflation Problem; Defective Device; Inflation Problem; Defective Device

  IT WAS REPORTED THAT THE PATIENT WITH THIS AMBICOR PENILE PROSTHESIS (APP) STATED HE HEARD A SOUND WHEN ATTEMPTING TO INFLATE THE DEVICE, WHICH THEN STOPPED INFLATING; THEREFORE, A REPLACEMENT SURGERY WAS SCHEDULED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21112362 ↗
• InjuryJul 17, 2024Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT AN AMBICOR PENILE PROSTHESIS (APP) WAS EXPLANTED DUE TO THE PUMP NOT WORKING. A NEW DEVICE WAS PLACED, AND NO PATIENT COMPLICATION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19760766 ↗
• InjuryJul 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT ENROLLED IN THE IT MATTERS STUDY AND WAS IMPLANTED WITH THIS AMBICOR PENILE PROSTHESIS (APP) ON (B)(6) 2024. TWENTY-SIX DAYS POST IMPLANT, THE PATIENT PRESENTED WITH HEMATOMA IN FRONT OF THE PUMP. THE PHYSICIAN SUSPECTED THAT THE HEMATOMA WAS A RESULT OF THE FURLOW INSERTION TOOL. THERE HAS BEEN NO SURGICAL INTERVENTION AND NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED. THE HEMATOMA WAS RESOLVED ON (B)(6) 2024.

  Patient problems: Hematoma

  MAUDE report 19701415 ↗
• InjuryJun 6, 2024Deflation Problem; Inflation Problem; Deflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INFLATABLE PENILE PROSTHESIS (IPP) REVISION DUE TO PUMP ISSUES. THE PUMP WOULD NOT INFLATE OR DEFLATE PROPERLY. THE DEVICE WAS REMOVED AND REPLACED. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19478217 ↗
• InjuryApr 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) EXHIBITED INFLATION ISSUES. A REVISION SURGERY WAS PERFORMED TO EXPLANT AND REPLACE THE DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19165890 ↗
• InjuryMar 5, 2024Inflation Problem; Mechanical Problem; Inflation Problem; Mechanical Problem

  IT WAS REPORTED THAT THIS AMBICOR PENILE PROSTHESIS STOPPED WORKING AS IT WAS NO LONGER INFLATING. A SURGICAL PROCEDURE WAS PERFORMED TO REMOVE THE DEVICE AND IMPLANT A NEW INFLATABLE PENILE PROSTHESIS. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18842717 ↗
• InjuryJan 22, 2024Deflation Problem; Degraded; Deflation Problem; Degraded

  IT WAS REPORTED THAT ONE THE CYLINDERS OF THIS AMBICOR PENILE PROSTHESIS (APP) COULD NOT BE DEFLATED. A SURGICAL PROCEDURE WAS PERFORMED, DURING WHICH IT WAS NOTED THAT THE LEFT CYLINDER HAD DEVELOPED A BULGE IN THE SILICONE; THEREFORE, THE EXISTING DEVICE WAS REMOVED, AND A NEW APP WAS IMPLANTED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18560066 ↗
• InjuryDec 20, 2023Fluid/Blood Leak; Mechanical Problem; Fluid/Blood Leak; Mechanical Problem

  IT WAS REPORTED THAT THIS AMBICOR PENILE PROSTHESIS (APP) WAS NOT WORKING PROPERLY DUE TO A FLUID LOSS. A REPLACEMENT SURGERY WAS PERFORMED TO REMOVE THE EXISTING APP AND IMPLANT A NEW MALLEABLE DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18369681 ↗
• InjuryDec 18, 2023Inflation Problem; Migration; Inflation Problem; Migration

  IT WAS REPORTED THAT THE PATIENT IS UNABLE TO CYCLE HIS INFLATABLE PENILE PROSTHESIS BECAUSE THE PUMP MIGRATED FROM THE ORIGINAL IMPLANT POSITION TO THE POSTERIOR SCROTUM. THE PATIENT UNDERWENT SURGERY AND THE DEVICE WAS REPLACED WITH A NON-BOSTON SCIENTIFIC PENILE PROSTHESIS. THERE WERE NO REPORTED PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18346809 ↗
• InjuryOct 19, 2023Fluid/Blood Leak; Mechanical Problem; Fluid/Blood Leak; Mechanical Problem

  IT WAS REPORTED THAT AN AMBICOR PENILE PROSTHESIS STOPPED WORKING DUE TO FLUID LOSS AT THE TUBING SITE. THE PATIENT UNDERWENT REPLACEMENT SURGERY, AND THE DEVICE WAS REPLACED COMPLETELY. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17965422 ↗
• InjurySep 25, 2023Degraded; Adverse Event Without Identified Device or Use Problem; Degraded; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT SURGICAL INTERVENTION TO EXPLANT THE AMBICOR PENILE PROSTHESIS (APP) DUE TO A BULGE OF THE RIGHT CYLINDER AND ADHESION OF THE PUMP TO THE RIGHT TESTICLE. A NEW APP WAS IMPLANTED AND THERE WERE NO ADDITIONAL PATIENT COMPLICATIONS REPORTED.

  Patient problems: Adhesion(s)

  MAUDE report 17814367 ↗
• MalfunctionSep 25, 2023Degraded; Fluid/Blood Leak; Inflation Problem; Degraded; Fluid/Blood Leak; Inflation Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH DIFFICULTY INFLATING THE AMBICOR PENILE PROSTHESIS (APP) AND A BULGE ON THE RIGHT SIDE OF THE DEVICE. THE PHYSICIAN BELIEVES THAT A REVISION IS NEEDED TO RESOLVE THE ISSUE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17813482 ↗
• InjuryMay 31, 2023Degraded; Inflation Problem; Degraded; Inflation Problem

  IT WAS REPORTED THAT THE AMBICOR PENILE PROSTHESIS (APP) WAS NOT INFLATING PROPERLY DUE TO A CYLINDER ANEURYSM. THE DEVICE WAS REMOVED AND REPLACED. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17035142 ↗
• InjuryMar 30, 2023Inflation Problem; Mechanical Problem; Inflation Problem; Mechanical Problem

  IT WAS REPORTED THAT THE PAST 8-9 MONTHS THE PATIENT REPORTED THAT HIS AMBICOR PENILE PROSTHESIS WOULD NOT GET AS ERECT AS IT PREVIOUSLY HAD. HE ALSO STATED THAT THE TUBING IN THE SCROTUM FELT HARD AND WAS CAUSING INTERNAL ITCHING AND DISCOMFORT. HE WAS SEEN BY A PHYSICIAN WHO INDICATED THE PUMP FELT STUCK. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Discomfort; Itching Sensation

  MAUDE report 16649512 ↗
• InjuryMar 28, 2023Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED INFLATION ISSUES WITH AN AMBICOR PENILE PROSTHESIS (APP). TROUBLESHOOTING WAS ATTEMPTED TO NO AVAIL. A SURGICAL PROCEDURE WAS PERFORMED DURING WHICH THE EXISTING DEVICE WAS EXPLANTED AND REPLACED WITH A NEW IPP. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16632497 ↗
• InjuryMar 13, 2023Fluid/Blood Leak; Inflation Problem; Material Puncture/Hole; Fluid/Blood Leak; Inflation Problem; Material Puncture/Hole

  IT WAS REPORTED THAT THE PATIENT HAD THE AMBICOR PENILE PROSTHESIS REPLACED AS IT WOULD NO LONGER INFLATE. THE PHYSICIAN SUSPECTED A FLUID LEAK THAT WAS CONFIRMED DURING THE REPLACEMENT SURGERY. A HOLE FROM FATIGUE IN THE TUBING FROM THE PUMP TO THE CYLINDER WAS FOUND. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16531923 ↗
• InjuryFeb 8, 2023Mechanical Problem; Adverse Event Without Identified Device or Use Problem; Mechanical Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD THIS AMBICOR PENILE PROSTHESIS REPLACED AS IT WAS NO LONGER FUNCTIONING. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16329770 ↗
• InjuryFeb 6, 2023Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED DISCOMFORT WITH AN AMBICOR PENILE PROSTHESIS (APP) DUE TO THE DEVICE STAYING PARTIALLY INFLATED AT TIMES. A REPLACEMENT SURGERY WAS PERFORMED IN WHICH THE EXISTING APP WAS REMOVED, AND A NEW INFLATABLE PENILE PROSTHESIS (IPP) WAS IMPLANTED. THERE WERE NO FURTHER PATIENT COMPLICATIONS.

  Patient problems: Discomfort

  MAUDE report 16304592 ↗
• MalfunctionJan 11, 2023Inflation Problem; Mechanical Problem; Inflation Problem; Mechanical Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED MECHANICAL PROBLEMS WITH THIS AMBICOR PENILE PROSTHESIS (APP) AS IT WOULD NOT INFLATE. A SURGICAL PROCEDURE WILL BE PERFORMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16137592 ↗
• InjuryDec 27, 2022Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT THE PREVIOUS AMBICOR PENILE PROSTHESIS (APP) LEFT CYLINDER WAS SIZED INCORRECTLY AND AN EROSION WAS EXPERIENCED BY THE PATIENT. A REVISION SURGERY WAS PERFORMED IN WHICH THE PHYSICIAN REMOVED AND REPLACED ONLY THE LEFT CYLINDER. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Erosion; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16052648 ↗