AMS 700 LGX MS Pump 72404300Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00878953005713), received between Jun 3, 2019 and Feb 11, 2025 — classified as 4 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Collapse” (2 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 11, 2025Collapse; Inflation Problem; Collapse; Inflation Problem

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) HAD INFLATION ISSUES. THE MAGNETIC RESONANCE IMAGING SHOWS SIGNS OF MALFUNCTION OF THE LEFT SHAFT OF THE INFLATABLE PENILE PROSTHESIS. ALSO, IT WAS NOTICED THAT THE PUMP STAYED FLAT. THE DEVICE IS STILL IMPLANTED, AND A SURGERY WILL BE BOOKED. NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21360252 ↗
• MalfunctionSep 11, 2024Fracture; Material Puncture/Hole; Defective Device; Fracture; Material Puncture/Hole; Defective Device

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) WAS NOT PERFORMING AS EXPECTED. THE PATIENT STATED THE DEVICE WAS LOSING RIGIDITY AS THE PATIENT WAS UNABLE TO PERFORM SEXUAL INTERCOURSE. AN MRI SCAN IDENTIFIED A POSSIBLE FRACTURE IN THE PROXIMAL SEGMENT OF THE LEFT SHAFT OF THE DEVICE. THE DEVICE REMAINS IMPLANTED, AND THE EXPLANT SURGERY IS ALREADY BOOKED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20195949 ↗
• InjuryOct 18, 2021Mechanical Problem; Material Puncture/Hole; Adverse Event Without Identified Device or Use Problem; Mechanical Problem; Material Puncture/Hole; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD THE INFLATABLE PENILE PROSTHESIS CYLINDERS AND PUMP REMOVED DUE TO A CYLINDER MICRO PUNCTURE AND PUMP MALFUNCTION. NEW INFLATABLE PENILE PROSTHESIS CYLINDERS AND PUMP WERE IMPLANTED. FOLLOWING THE SURGERY THE EVENT RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12647467 ↗
• InjurySep 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A SURGICAL PROCEDURE TO REVISE THIS INFLATABLE PENILE PROSTHESIS (IPP) DUE TO PAIN AT THE SURGICAL SITE. THE IPP WAS EXPLANTED AND NOT REPLACED WITH NO CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: Pain

  MAUDE report 12470981 ↗
• InjuryJun 28, 2021Collapse; Mechanical Problem; Collapse; Mechanical Problem

  IT WAS REPORTED THAT THE PATIENT INDICATED THE INFLATABLE PENILE PROSTHESIS (IPP) PUMP FELT VERY HARD AFTER WORKING NORMALLY FOR THE FIRST THREE MONTHS. DURING AN APPOINTMENT WITH THE PHYSICIAN, THE PUMP INFLATED THE FIRST TIME IT WAS TESTED; HOWEVER, ON SUBSEQUENT ATTEMPTS THE PUMP WOULD REMAIN COLLAPSED. TROUBLESHOOTING WAS ATTEMPTED TO NO AVAIL BY FOLLOWING THE INSTRUCTIONS ON THE OPERATING ROOM MANUAL. A REPLACEMENT SURGERY WAS PERFORMED IN WHICH THE EXISTING DEVICE WAS REMOVED AND A NEW IPP WAS IMPLANTED. THERE WERE NO PATIENT COMPLICATIONS ASSOCIATED TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12075273 ↗
• InjurySep 23, 2020Fluid/Blood Leak; Fracture; Fluid/Blood Leak; Fracture

  IT WAS REPORTED THAT DUE TO A TUBE CRACK AND FLUID LOSS THE PATIENT HAD HIS INFLATABLE PENILE PROSTHESIS (IPP) EXPLANTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10577616 ↗
• MalfunctionJun 3, 2019Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH THINNING OF THE PENIS AND AN INFLATED IMPLANT WITHOUT AXIAL STIFFNESS WITH A FOLD IN THE MIDDLE RESULTING IN A NONFUNCTIONAL PENIS NEW SCHEDULED SURGERY AND THE PROCEDURE WILL BE THE RECONSTRUCTION OF THE CAVERNOUS BODIES AND EXCHANGE OF PENILE PROSTHESIS. FURTHER INFORMATION WAS REQUESTED AND NOT YET RECEIVED. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8663239 ↗