AMS 700 LGX MS Pump 72404256Recalls & reported problems

Summary

The FDA's MAUDE database contains 139 adverse event reports that list this exact device (DI 00878953003641), received between Oct 31, 2018 and Sep 21, 2026 — classified as 131 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Inflation Problem” (47 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 139 reports, in the reporter's own words as published by the FDA.

• InjurySep 21, 2026Inadequacy of Device Shape and/or Size

  It was reported that patient complained of floppy glands. Upon inspection, physician found that tips of the Inflatable Penile Prosthesis (IPP) did not come to the top of the penile gland. As a result, the device was explanted and replaced. No further patient complications were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50840530 ↗
• InjuryAug 6, 2026Inflation Problem; Material Deformation

  It was reported that the patient's Inflatable Penile Prosthesis (IPP) was not achieving full rigidity. A potential kink in the pump tubing was suspected; however, the presence of a kink could not be confirmed, as no specific issue was identified with any individual component of the device. The suspected cause of the malfunction was either long term device use or changes associated with the healing process that may have resulted in a tubing kink. As a result, a surgical revision procedure was performed to replace the pump. No patient complications were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50168036 ↗
• InjuryJul 10, 2026Fluid/Blood Leak; Inflation Problem

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) WAS NOT ABLE TO INFLATE /PUMP. A SURGICAL PROCEDURE WAS PERFORMED DURING WHICH THE DEVICE WAS EXPLANTED AND REPLACED WITH A TACTRA DEVICE. UPON EXPLANT THE PHYSICIAN IDENTIFIED FLUID LEAKAGE BUT WAS UNABLE TO DETERMINE WHERE THE LEAK WAS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25788525 ↗
• InjuryMay 18, 2026Fluid/Blood Leak; Nonstandard Device

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) IMPLANT DEVICE HAD FLUID LOSS. A SURGICAL PROCEDURE WAS PERFORMED DURING WHICH THE DEVICE WAS REMOVED AND REPLACED. UPON EXPLANT, THE PHYSICIAN NOTED THE SYSTEM WAS EMPTY. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25210486 ↗
• InjuryMay 18, 2026Migration

  IT WAS REPORTED THAT THE PATIENT WITH THIS INFLATABLE PENILE PROSTHESIS (IPP) EXPERIENCED HERNIATION OF THE RIGHT CYLINDER AND WAS DISSATISFIED WITH THE DEVICE. A SURGICAL PROCEDURE WAS PERFORMED IN WHICH THE EXISTING DEVICE WAS EXPLANTED AND REPLACED. THERE WERE NO FURTHER PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25197472 ↗
• InjuryMay 15, 2026Inflation Problem; Mechanical Problem; Nonstandard Device

  IT WAS REPORTED THAT THE PATIENT WITH AN INFLATABLE PENILE PROSTHESIS (IPP) IMPLANT DEVICE EXPERIENCED ONGOING ISSUES WITH THEIR SCROTAL PUMP. THE SURGEON NOTED THAT THE PUMP WAS FAULTY AS THE LOCK OUT VALVE SIMPLY DID NOT WORK PROPERLY, AND THE CHAMBER IMMEDIATELY REFILLED ONCE IT WAS SQUEEZED. A SURGICAL PROCEDURE WAS PERFORMED DURING WHICH THE PUMP WAS EXPLANTED AND REPLACED. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25186883 ↗
• InjuryApr 16, 2026Fluid/Blood Leak; Inflation Problem; Material Puncture/Hole

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) IMPLANT DEVICE WAS UNABLE TO BE FILLED AND WOULD NOT PUMP. A SURGICAL PROCEDURE WAS PERFORMED DURING WHICH THE ENTIRE DEVICE WAS EXPLANTED AND REPLACED. UPON EXPLANT, THE PHYSICIAN IDENTIFIED A HOLE ON THE LEFT CYLINDER. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24899607 ↗
• InjuryMar 11, 2026Nonstandard Device

  THIS PRODUCT WAS RETURNED TO THE MANUFACTURER WITHOUT ANY REPORT OF PERFORMANCE ISSUES OR ADVERSE PATIENT EFFECTS. THE RETURNED DEVICE WAS ANALYZED AND A NON CONFORMANCE WAS IDENTIFIED. SEE ADDITIONAL MANUFACTURER NARRATIVE FOR FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24572229 ↗
• InjuryDec 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WITH AN INFLATABLE PENILE PROSTHESIS (IPP) PRESENTED WITH AN INFECTION. THE PHYSICIAN STATED THAT THE PATIENT VISITED THE OFFICE WITH PUS COMING FROM THE INCISION SITE. THE DRAIN CONTINUED TO HAVE 60 ML OF DRAINAGE ON DAY 9 AND WAS NOT REMOVED BY THE NURSE UNTIL DAY 29. A REVISION SURGERY WAS PERFORMED, DURING WHICH THE PHYSICIAN REMOVED THE INFECTED IMPLANT, IRRIGATED THE AREA, AND PLACED A TACTRA DEVICE. THERE WERE NO FURTHER PATIENT COMPLICATIONS.

  Patient problems: Purulent Discharge; Unspecified Infection

  MAUDE report 23914208 ↗
• InjuryDec 23, 2025Collapse; Fluid/Blood Leak; Inflation Problem; Air/Gas in Device; Collapse; Fluid/Blood Leak; Inflation Problem; Air/Gas in Device

  IT WAS REPORTED THAT THE PATIENT'S INFLATABLE PENILE PROSTHESIS (IPP) EXHIBITED INFLATION ISSUES, PREVENTING THE PATIENT FROM MAINTAINING AN ERECTION. THE PUMP REMAINED FLAT DESPITE REPEATED ATTEMPTS TO INFLATE. DURING A SURGICAL PROCEDURE, FLUID LOSS AND AIR WERE IDENTIFIED. THE IPP WAS REMOVED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23883899 ↗
• InjuryDec 16, 2025Mechanical Problem; Inadequacy of Device Shape and/or Size; Mechanical Problem; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) WAS NOT PERFORMING AS EXPECTED DUE TO ORIGINAL IMPLANT WAS UNDERSIZED. THE CYLINDERS WERE EXPLANTED, NEW CYLINDERS WERE PLACED, AND THE RESERVOIR WAS RETAINED AND USED FOR THE SYSTEM. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23817635 ↗
• InjuryOct 28, 2025Collapse; Deflation Problem; Inflation Problem; Collapse; Deflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE PATIENT WITH THIS INFLATABLE PENILE PROSTHESIS (IPP) EXPERIENCED SEVERAL ISSUES, INCLUDING THE PUMP BULB GOING FLAT AND NOT INFLATING THE DEVICE, AND THE DEFLATE BUTTON NOT FUNCTIONING PROPERLY. THE PATIENT ALSO REPORTED PAIN IN THE SHAFT WHEN THE DEVICE DOES INFLATE. THERE WERE NO FURTHER PATIENT COMPLICATIONS REPORTED.

  Patient problems: Pain

  MAUDE report 23408029 ↗
• InjurySep 19, 2025Adverse 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 SCROTAL PAIN. A SURGICAL PROCEDURE WAS PERFORMED TO REMOVE AND REPLACE THE IPP. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Pain

  MAUDE report 23101174 ↗
• InjurySep 10, 2025Fluid/Blood Leak; Inflation Problem; Material Puncture/Hole; Fluid/Blood Leak; Inflation Problem; Material Puncture/Hole

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) PRESENTED AN INFLATION PROBLEM AS FLUID LEAKAGE WAS REPORTED, ORIGINATING FROM HOLES IN BOTH CYLINDERS. THE IPP WAS EXPLANTED AND REPLACED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23014854 ↗
• InjurySep 5, 2025Fluid/Blood Leak; Inflation Problem; Material Puncture/Hole; Fluid/Blood Leak; Inflation Problem; Material Puncture/Hole

  IT WAS REPORTED THAT THE PATIENT WITH AN INFLATABLE PENILE PROSTHESIS (IPP) STATED THAT THE DEVICE STOPPED WORKING, AS HE WAS UNABLE TO INFLATE THE DEVICE. UPON REVISION, IT WAS FOUND THAT ONE OF THE CYLINDERS HAD RUPTURED, RESULTING IN FLUID LOSS. THEREFORE, THE IPP WAS REMOVED AND REPLACED WITH A TACTRA DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22987016 ↗
• InjuryAug 14, 2025Fluid/Blood Leak; Mechanical Problem; Fluid/Blood Leak; Mechanical Problem

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) PRESENTED A MECHANICAL PROBLEM AND A FLUID LOSS. THE IPP WAS EXPLANTED AND REPLACED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22803842 ↗
• InjuryJul 1, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE RESERVOIR OF THE INFLATABLE PENILE PROSTHESIS (IPP) HAD HERNIATED INTO THE PATIENT'S SCROTUM. DURING THE SURGICAL PROCEDURE, THE PHYSICIAN INFLATED THE CYLINDERS AFTER REMOVING THE RESERVOIR FROM THE SCROTUM AND DISCOVERED THAT THE RIGHT CYLINDER HAD ERODED INTO THE URETHRA. A CYSTOSCOPY WAS PERFORMED, CONFIRMING THE EROSION, AND THE REPLACEMENT PROCEDURE WAS SUBSEQUENTLY ABORTED. A NEW CONCEAL-TYPE RESERVOIR WAS PLACED IN THE SPACE OF RETZIUS. THE ERODED RIGHT CYLINDER WAS REMOVED, WHILE THE EXISTING LEFT CYLINDER AND THE PUMP WERE LEFT IN PLACE. A FOLLOW-UP REVISION SURGERY IS PLANNED ONCE THE URETHRA HAS ADEQUATELY HEALED. NO ADDITIONAL PATIENT COMPLICATIONS HAVE BEEN REPORTED AT THIS TIME.

  Patient problems: Erosion

  MAUDE report 22378832 ↗
• InjuryMay 27, 2025Material 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 UNDERWENT AN INFLATABLE PENILE PROSTHESIS (IPP) REPLACEMENT SURGERY DUE TO RUPTURE IN ONE CYLINDER. THE IPP WAS REMOVED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22088379 ↗
• InjuryMay 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WITH THIS INFLATABLE PENILE PROSTHESIS EXPERIENCED PERSISTENT PAIN IN THE SCROTUM NEAR THE PUMP AREA. A REVISION SURGERY WAS PERFORMED IN WHICH THE PHYSICIAN REMOVED THE PUMP, DRAINED AND RETAINED THE RESERVOIR, AND LEFT THE CYLINDERS SEMI FILLED AND CONNECTED WITH A CONNECTOR. THERE WERE NO FURTHER PATIENT COMPLICATIONS.

  Patient problems: Pain

  MAUDE report 22081603 ↗
• InjuryJan 13, 2025Inflation Problem; Defective Device; Inflation Problem; Defective Device

  IT WAS REPORTED THAT THE RESERVOIR OF THIS INFLATABLE PENILE PROSTHESIS (IPP) WHEN SQUEEZED DOES NOT REFILL THE PUMP. THE PATIENT WAS NOT CONSENTED TO HAVE WORK DONE ON THE RESERVOIR SO THE PROCEDURE WILL BE RESCHEDULED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21144798 ↗
• InjuryDec 3, 2024Inflation Problem; Failure to Deflate; Inflation Problem; Failure to Deflate

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) EXHIBITED AUTO INFLATION ISSUES AND WAS DIFFICULT TO DEFLATE. A SURGICAL PROCEDURE WAS PERFORMED TO REMOVE AND REPLACE THE PUMP. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20833514 ↗
• InjuryNov 19, 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 DISCOMFORT DUE TO DISTAL EROSION. A SURGICAL PROCEDURE WAS PERFORMED TO REMOVE AND REPLACE ALL THE COMPONENTS. THERE WERE NO DEVICE ISSUES AND NO FURTHER PATIENT COMPLICATIONS REPORTED.

  Patient problems: Discomfort; Erosion

  MAUDE report 20726773 ↗
• InjuryNov 19, 2024Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) WAS NO LONGER INFLATING; THEREFORE, THE DEVICE WAS REMOVED AND REPLACED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20725569 ↗
• InjurySep 23, 2024Deflation Problem; Inflation Problem; Mechanical Problem; Deflation Problem; Inflation Problem; Mechanical Problem

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) WAS NOT FUNCTIONING. THERE WERE DEFLATION AND INFLATION ISSUES. IT WAS NOTED THAT THE LEFT CYLINDER WAS NOT DEFLATING PROPERLY. THE IPP WAS EXPLANTED AND REPLACED. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20279429 ↗
• InjurySep 21, 2024Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE PATIENT HAD A SURGICAL PROCEDURE TO REPLACE AN INFLATABLE PENILE PROSTHESIS (IPP) PUMP DUE TO THE PUMP NOT OPERATING ANYMORE. THE PUMP WAS NOT ABLE TO PUMP TO THE FULL CAPACITY ANYMORE LIKELY DUE TO THE AGE OF THE DEVICE OR A STICKY PUMP/VALVE ISSUE. THE PATIENT IS EXPECTED TO FULLY RECOVER FOLLOWING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20275485 ↗