AMS 700 LGX MS Pump 72404303Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00878953005744), received between Jul 18, 2019 and Mar 10, 2026 — classified as 9 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Inflation Problem” (8 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryMar 10, 2026Mechanical Problem

  IT WAS REPORTED THAT THIS PATIENT WITH AN INFLATABLE PENILE PROSTHESIS (IPP) IMPLANT DEVICE EXPERIENCED THE DEVICE NOT WORKING DUE TO A PUMP MECHANICAL FAILURE. A SURGICAL PROCEDURE WAS PERFORMED DURING WHICH THE DEVICE WAS EXPLANTED AND REPLACED. THE PATIENT FULLY RECOVERED, AND THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24558857 ↗
• MalfunctionSep 26, 2024Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) WAS NOT PERFORMING AS EXPECTED DUE TO AN INFLATION ISSUE. THE IPP IS CURRENTLY IMPLANTED, THE EXPLANT SURGERY IS ALREADY BOOKED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20310663 ↗
• InjurySep 10, 2024Mechanical Problem; Migration; Mechanical Problem; Migration

  IT WAS REPORTED THAT THE PATIENT WITH THIS INFLATABLE PENILE PROSTHESIS (IPP) PRESENTED WITH MALFUNCTION OF THE PROSTHESIS. IT WAS NOTED THAT THE PROSTHESIS MIGRATED FROM THE CORPUS CAVERNOSUM TO BEING PARTIALLY LOCATED SUBCUTANEOUSLY. THE IPP IS CURRENTLY IMPLANTED. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20184279 ↗
• MalfunctionJun 6, 2024Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) EXHIBITED INFLATION ISSUES; THEREFORE, A REVISION SURGERY IS PLANNED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19477412 ↗
• MalfunctionMar 4, 2024Degraded; Inflation Problem; Degraded; Inflation Problem

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) EXHIBITED INFLATION ISSUES. THE PATIENT STATED THAT THERE IS A BULGING AT THE BASE OF THE PENIS ON THE LEFT SIDE WHEN INFLATING THE IPP. MEDICAL EXAMINATION WAS PERFORMED, AND IT WAS NOTED THAT THERE IS A FLACCID AREA ON THE LATERAL WALL OF THE CORPUS CAVERNOSUM WHEN THE LEFT CYLINDER IS PRESSED. A REVISION SURGERY HAS BEEN PLANNED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18828199 ↗
• InjuryOct 4, 2023Mechanical Problem; Material Puncture/Hole; Mechanical Problem; Material Puncture/Hole

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) STOPPED WORKING BECAUSE THE CYLINDER HAD BROKEN. THE CYLINDER WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17868167 ↗
• InjuryFeb 20, 2023Fluid/Blood Leak; Mechanical Problem; Connection Problem; Migration; Fluid/Blood Leak; Mechanical Problem; Connection Problem; Migration

  IT WAS REPORTED THAT THE INFLATABLE PENILE PROSTHESIS STOPPED WORKING. THE PATIENT EXPERIENCED DISCOMFORT DUE TO THE DEVICE NOT WORKING. THE PHYSICIAN REPORTS THAT APPARENTLY THERE WAS A LEAK OF FLUID IN THE RESERVOIR WHICH RESULTED IN THE INABILITY TO INFLATE THE PROSTHESIS. THE PHYSICIAN NOTED THAT THE TUBE CONNECTING THE PUMP TO THE RESERVOIR WAS MOST LIKELY DISCONNECTED. WHEN HE CHECKED THE PATIENT, HE FELT THE DEFLATED RESERVOIR OUTSIDE THE INGUINAL RING AND STATED THAT, DUE TO THE SUSPECTED FLUID LEAK, THE RESERVOIR HAD LIKELY MIGRATED THROUGH THE INGUINAL RING.

  Patient problems: Discomfort

  MAUDE report 16402473 ↗
• InjuryMay 20, 2022Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE PATIENT WITH AN INFLATABLE PENILE PROSTHESIS (IPP) PRESENTED WITH PROSTHETIC INFECTION. DUE TO THE PAIN FROM THE INFECTION AND THE DIFFICULTY WITH PRESSING THE PUMP, THE PATIENT WAS UNABLE TO CYCLE AND INFLATE THE DEVICE. THE PATIENT UNDERWENT A SURGICAL PROCEDURE TO EXPLANT THE IPP AND IMPLANT A NEW TACTRA MALLEABLE PENILE PROSTHESIS. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Inflammation; Pain; Unspecified Infection

  MAUDE report 14459419 ↗
• MalfunctionJan 12, 2022Fluid/Blood Leak; Inflation Problem; Fluid/Blood Leak; Inflation Problem

  IT WAS REPORTED THAT THE INFLATABLE PENILE PROSTHESIS WOULD NOT INFLATE. AFTER IMAGING, A COLLAPSED AND EMPTY RESERVOIR WAS OBSERVED. THE PATIENT WAS EXPECTED TO UNDERGO A REVISION PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13237917 ↗
• InjuryApr 28, 2021Inflation Problem; Mechanical Problem; Inflation Problem; Mechanical Problem

  IT WAS REPORTED THAT THE INFLATABLE PENILE PROSTHESIS (IPP) DEVICE HAD INADEQUATE INFLATION. ALL COMPONENTS WERE EXPLANTED AND REPLACED. THE PATIENT IS DOING WELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11737456 ↗
• InjuryApr 9, 2020Failure to Cycle; Material Discolored; Inflation Problem; Malposition of Device; Failure to Cycle; Material Discolored; Inflation Problem; Malposition of Device

  IT WAS REPORTED THAT THE PATIENT IS EXPERIENCING PAIN AT THE BASE OF THE PENIS AND SPONTANEOUS INSUFFLATION OF THE PROSTHESIS AFTER COMPLETELY EMPTYING THE CYLINDERS WITH AN INFLATABLE PENILE PROSTHESIS (IPP). THE IPP REMAINS IMPLANTED AND ACTIVE. MAGNETIC RESONANCE IMAGING WAS COMPLETED, A CALIBER DIFFERENCE BETWEEN THE CYLINDER IN THE DISTAL PORTION WAS OBSERVED. AN ULTRASOUND FOUND A REDUCTION IN THE IPSILATERAL CALIPER.

  Patient problems: Discomfort; Pain; Tissue Damage

  MAUDE report 9944028 ↗
• InjuryFeb 5, 2020Failure to Cycle; Adverse Event Without Identified Device or Use Problem; Failure to Cycle; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DUE TO THE CYLINDERS NOT FILLING EVEN AFTER DISPLACING/COMPRESSING THE PUMP; THE MEDIUM COULD NOT BE DRAWN INTO THE PUMP FOLLOWING THE PUMP IMPACTS. THE PATIENT HAD HIS INFLATABLE PENILE PROSTHESIS (IPP) REMOVED AND REPLACED. THE IPP WAS EXPLANTED AND A NEW DEVICE CONSISTING OF CYLINDERS, PUMP, AND RESERVOIR WERE IMPLANTED. IT WAS REPORTED THAT THERE WERE NO PATIENT COMPLICATIONS ASSOCIATED WITH THIS SURGERY. FURTHER INFORMATION INDICATED THAT THIS WAS AN ATTEMPTED PUMP IMPLANT, BUT THE PUMP NEEDED TO BE REPLACED DUE TO AFTER MOVING/COMPRESSING THE PUMP, THE CYLINDERS WERE NOT FILING. A DIFFERENT PUMP WAS USED TO ACHIEVE THE DESIRED RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9673450 ↗
• InjuryJul 18, 2019Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE INFLATABLE PENILE PROSTHESIS (IPP) CYLINDERS AND PUMP WERE EXPLANTED DUE TO EROSION. IT WAS FURTHER REPORTED THAT THREE WEEKS PRIOR TO SURGERY THE DEVICE WOULD NOT INFLATE. DURING THE SURGERY IT WAS IDENTIFIED THAT THE CYLINDERS HAD ERODED AT THE CAVERNOUS BODY.

  Patient problems: Erosion

  MAUDE report 8804145 ↗