AMS 700 LGX MS Pump 72404302Recalls & reported problems

Summary

The FDA's MAUDE database contains 67 adverse event reports that list this exact device (DI 00878953005737), received between Jan 7, 2019 and Sep 24, 2026 — classified as 51 injuries, 16 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (32 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 25 most recent of 67 reports, in the reporter's own words as published by the FDA.

• InjurySep 24, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient with this Inflatable Penile Prosthesis (IPP) developed an infection approximately ten months after implantation. The physician treated the infection with antibiotics. A surgical procedure was performed in which the existing IPP was explanted and replaced with a new Inflatable Penile Prosthesis (IPP). The physician indicated that the infection was attributed to a microbial source and not to foreign material associated with the device. There were no further patient complications reported.

  Patient problems: Unspecified Infection

  MAUDE report 50885682 ↗
• InjuryAug 14, 2026Collapse; Mechanical Problem

  It was reported that the patient with an Inflatable Penile Prosthesis (IPP) was unable to use the device normally because the pump could not be pressurized and would not rebound. A revision procedure was performed during which the entire system was explanted; however, no replacement device was implanted. No patient complications were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50260521 ↗
• InjuryAug 14, 2026Collapse; Inflation Problem; Mechanical Problem; Difficult or Delayed Activation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50256062 ↗
• InjuryJan 14, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WITH THIS INFLATABLE PENILE PROSTHESIS (IPP) EXPERIENCED INFLAMMATION. A SURGICAL PROCEDURE WAS PERFORMED IN WHICH THE DEVICE WAS COMPLETELY REMOVED AND REPLACED. THERE WERE NO FURTHER PATIENT COMPLICATIONS REPORTED.

  Patient problems: Inflammation

  MAUDE report 24068105 ↗
• InjuryJan 7, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WITH THIS INFLATABLE PENILE PROSTHESIS (IPP) DEVELOPED FEVER, DISCOMFORT, AND INFECTION. THE PATIENT WAS ADDITIONALLY REPORTED TO PRESENT PURULENT DISCHARGE. THE IPP WAS EXPLANTED AND REPLACED. THERE IS NO ADDITIONAL INFORMATION REPORTED.

  Patient problems: Discomfort; Fever; Purulent Discharge; Unspecified Infection

  MAUDE report 23988676 ↗
• InjuryJan 5, 2026Collapse; Inflation Problem

  IT WAS REPORTED THAT THE PATIENT'S INFLATABLE PENILE PROSTHESIS (IPP) EXHIBITED INFLATION ISSUES, AND THE PUMP WAS NOT FUNCTIONING PROPERLY, COLLAPSING DURING USE. TROUBLESHOOTING ATTEMPTS BY THE PHYSICIAN WERE UNSUCCESSFUL. A SURGICAL PROCEDURE WAS PERFORMED TO REPLACE ALL COMPONENTS EXCEPT THE RESERVOIR. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23956061 ↗
• InjuryDec 31, 2025Inflation Problem; Inflation Problem; Nonstandard Device

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) DOES NOT INFLATE WHEN THE PATIENT PRESSES THE PUMP. A SURGICAL PROCEDURE WAS PERFORMED TO REMOVE AND REPLACE THE IPP. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23934334 ↗
• InjuryDec 16, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE PATIENT WITH THIS INFLATABLE PENILE PROSTHESIS (IPP) EXPERIENCED ISSUES WITH THE PUMP. THE PHYSICIAN ATTEMPTED TROUBLESHOOTING IN THE OPERATING ROOM, BUT THE ISSUE COULD NOT BE RESOLVED. A SURGICAL PROCEDURE WAS PERFORMED IN WHICH THE DEVICE WAS REMOVED AND REPLACED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23816067 ↗
• InjuryDec 9, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) HAD A TUBE DAMAGE. AS A RESULT, THE CYLINDER AND PUMP WERE EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23753754 ↗
• InjurySep 17, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE PUMP OF THIS INFLATABLE PENILE PROSTHESIS (IPP) WAS NOT FUNCTIONING, AS IT WAS UNABLE TO TRANSFER FLUID FROM THE RESERVOIR TO THE CYLINDERS. ADDITIONALLY, THE PATIENT EXPERIENCED DISABILITY OR PERMANENT DAMAGE. A REVISION SURGERY HAS BEEN SCHEDULED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 23077617 ↗
• InjuryJun 19, 2025Collapse; Inflation Problem; Mechanical Problem; Nonstandard Device; Collapse; Inflation Problem; Mechanical Problem; Nonstandard Device

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) PRESENTED AN INFLATION PROBLEM, IT WAS REPORTED THAT THE PUMP STAYS FLAT. THE IPP WAS EXPLANTED AND REPLACED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22290129 ↗
• InjuryMay 9, 2025Defective Device; Defective Device

  IT WAS REPORTED THAT, FOUR MONTHS AFTER IMPLANT PROCEDURE, THE PUMP OF THIS INFLATABLE PENILE PROSTHESIS (IPP) WOULD OCCASIONALLY BECOME STIFF WHEN SQUEEZED, MAKING IT DIFFICULT FOR THE PATIENT TO PRESS IT. THIS CAUSED SIGNIFICANT PAIN AND DISTRESS. ADDITIONALLY, EXCESSIVE FORCE WAS REQUIRED TO RELEASE THE PUMP AND RETURN IT TO ITS INITIAL STATE. A SURGICAL PROCEDURE WAS PERFORMED TO REMOVE AND REPLACE CYLINDERS AND PUMP. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Pain

  MAUDE report 21994052 ↗
• InjuryMar 7, 2025Inflation Problem; Mechanical Problem; Inflation Problem; Mechanical Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH AN INABILITY TO INFLATE THEIR INFLATABLE PENILE PROSTHESIS IPP DEVICE AFTER THREE YEARS OF USE. THE PATIENT ALLEGES THAT WHEN TRYING TO ACTIVATE IT, THE DEVICE WILL NOT FILL WHEN PRESSING THE FILLING PUMP, IT IS VERY HARD AND DOES NOT SEND THE LIQUID. THE PHYSICIAN SUSPECTED DURING A REVISION APPOINTMENT THAT THE PATIENT WAS HAVING DIFFICULTY MANIPULATING THE PUMP DUE TO A MECHANICAL ISSUE RELATED TO THE PUMP, LEADING TO THE INABILITY TO INFLATE THE DEVICE. PATIENT NEXT APPOINTMENT FOR REVISION WOULD BE SCHEDULED IN THE OPERATING ROOM FOR EXPLANTATION OF THE DEVICE AND IMPLANTATION OF A NEW ONE. THE PATIENT CURRENTLY HAS THE DEVICE IMPLANTED, AND IT HAS NOT BEEN CHANGED OR REMOVED. THE NEXT COURSE OF ACTION IS TO REMOVE THE DEVICE AND IMPLANT A NEW ONE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21547430 ↗
• InjuryJan 28, 2025Collapse; Inflation Problem; Mechanical Problem; Connection Problem; Collapse; Inflation Problem; Mechanical Problem; Connection Problem

  IT WAS REPORTED THAT THE PATIENT STATED THIS INFLATABLE PENILE PROSTHESIS (IPP) WAS NOT WORKING PROPERLY, AS PUMP WAS STAYING COLLAPSED PREVENTING CYLINDER INFLATION. THE PHYSICIAN EVALUATED THE DEVICE AND CONFIRMED THE ISSUE; THEREFORE, A REVISION SURGERY WAS PERFORMED, IN WHICH IT WAS NOTED THAT THE TUBING BETWEEN RESERVOIR AND PUMP WAS DISCONNECTED. THE SYSTEM WAS PURGED, CLEANED, REFILLED AND RECONNECTED. NO COMPONENTS WERE REPLACED, AND NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21255237 ↗
• InjuryOct 14, 2024Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) WAS NOT WORKING. THE PHYSICIAN RECOMMENDED A REVISION SURGERY, AND THIS ONE IS ALREADY BOOKED, THE IPP IS CURRENTLY IMPLANTED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20439195 ↗
• InjuryOct 2, 2024Material Puncture/Hole; Adverse Event Without Identified Device or Use Problem; Material Puncture/Hole; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WITH THIS INFLATABLE PENILE PROSTHESIS (IPP) UNDERWENT A REVISION DUE TO A BROKEN CYLINDER. THE IPP WAS REMOVED AND REPLACED. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20351784 ↗
• InjuryAug 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 INFLATABLE PENILE PROSTHESIS (IPP) HAD A POSTERIOR EXTENSION BODY INSTALLED ON THE LEFT SIDE AND NO POSTERIOR EXTENSION BODY INSTALLED ON THE RIGHT SIDE. THE PATIENT EXPERIENCED PAIN DURING THE PROCEDURE, AND AN INFECTION WAS FOUND A FEW DAYS LATER IN THE SCROTUM EXTENDING TO THE CORPUS CAVERNOSUM. THE PHYSICIAN SUSPECTED THAT THE PATIENT BLOOD SUGAR WAS NOT CONTROLLED VERY WELL. THERE WAS NO IMPROVEMENT AFTER DETOXIFICATION AND DRAINAGE TREATMENT. THE IPP WAS EXPLANTED AND WILL BE RE-IMPLANTED SIX MONTHS LATER. THERE WERE NO ADDITIONAL PATIENT COMPLICATIONS REPORTED.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 20029794 ↗
• InjuryJun 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WITH THIS INFLATABLE PENILE PROSTHESIS (IPP) EXPERIENCED INFECTION. THE IPP WAS EXPLANTED. THERE WERE NO DEVICE ISSUES AND NO ADDITIONAL PATIENT COMPLICATIONS REPORTED.

  Patient problems: Unspecified Infection

  MAUDE report 19498113 ↗
• MalfunctionMay 14, 2024Collapse; Deflation Problem; Inflation Problem; Mechanical Problem; Collapse; Deflation Problem; Inflation Problem; Mechanical Problem

  IT WAS REPORTED THAT THE PATIENT WITH THIS INFLATABLE PENILE PROSTHESIS (IPP) PRESENTED WITH THE DEVICE NO LONGER INFLATING OR DEFLATING AS INTENDED. THE PUMP REMAINS FLAT AND WAS NOT RESOLVED WITH TROUBLESHOOTING. THE PATIENT IS UNCOMFORTABLE WITH THE IDEA OF A PROCEDURE, SO THERE HAS BEEN NO SURGICAL INTERVENTION AT THIS TIME. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19314039 ↗
• MalfunctionMay 14, 2024Inflation Problem; Mechanical Problem; Inflation Problem; Mechanical Problem

  IT WAS REPORTED THAT THE PUMP IN THIS INFLATABLE PENILE PROSTHESIS (IPP) WAS NOT PERFORMING AS EXPECTED DUE TO THE TUBING CAME LOOSE BETWEEN THE CYLINDERS AND RESERVOIR. THE DEVICE DID NOT INFLATE. THE DEVICE REMAINS IMPLANTED. A REVISION PROCEDURE IS SCHEDULED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19310201 ↗
• InjuryApr 3, 2024Deflation Problem; Defective Device; Deflation Problem; Defective Device

  IT WAS REPORTED THAT, ONE WEEK AFTER THE IMPLANT PROCEDURE, THE PUMP OF THIS INFLATABLE PENILE PROSTHESIS WAS PRESSED, AND IT AUTOMATICALLY FILLED WITH FLUID AND REMAINED SWOLLEN. IT WAS NOTED THAT THE COMPONENT REMAINED SWOLLEN EVEN AFTER TROUBLESHOOTING WAS ATTEMPTED FROM THE MEDICAL STAFF. IN ADDITION, THE CYLINDERS WERE ALSO NOT DEFLATING AFTER THE PUMP WAS PRESSED. THE PHYSICIAN BELIEVES IT HAPPENED BECAUSE THE DISCHARGE BUTTON COULD NOT BOUNCE BACK NORMALLY, AS IT DID NOT HAVE REBOUND FORCE; THEREFORE, THE COMPONENT WAS REMOVED AND REPLACED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19038820 ↗
• MalfunctionApr 3, 2024Inflation Problem; Mechanical Problem; Inflation Problem; Mechanical Problem

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) EXHIBITED INFLATION ISSUES AS THE PUMP IS HARD TO SQUEEZE. TROUBLESHOOTING WITHOUT RESOLUTION WAS ATTEMPTED. THE DEVICE REMAINS IMPLANTED, AND NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19034344 ↗
• MalfunctionMar 6, 2024Fluid/Blood Leak; Mechanical Problem; Fluid/Blood Leak; Mechanical Problem

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) IS NO LONGER FUNCTIONING AS EXPECTED. AN ULTRASOUND WAS PERFORMED, AND IT WAS FOUND THAT THERE WAS NO FLUID LEFT IN THE RESERVOIR WHICH INDICATES FLUID LEAKAGE AT AN UNSPECIFIED LOCATION. THE DEVICE REMAINS IMPLANTED, AND NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18851832 ↗
• InjuryDec 13, 2023Fluid/Blood Leak; Material Puncture/Hole; Adverse Event Without Identified Device or Use Problem; Fluid/Blood Leak; Material Puncture/Hole; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) EXHIBITED FLUID LEAKAGE DUE TO DAMAGE IN THE LEFT CYLINDER. A REVISION SURGERY WAS PERFORMED TO EXPLANT AND REPLACE THE DEVICE. NO FURTHER DETAILS WERE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18320972 ↗
• InjurySep 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DESCRIBED FEELING SWOLLEN AND ITCHY DUE TO AN INFECTION AFTER THE IMPLANT OF AN INFLATABLE PENILE PROSTHESIS (IPP) DEVICE. THE DEVICE WAS EXPLANTED, AND NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Itching Sensation; Swelling/ Edema; Unspecified Infection

  MAUDE report 17682282 ↗