AMS 700 LGX MS Pump 72404258Recalls & reported problems

Summary

The FDA's MAUDE database contains 85 adverse event reports that list this exact device (DI 00878953003665), received between Nov 19, 2018 and Sep 21, 2026 — classified as 74 injuries, 11 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 85 reports, in the reporter's own words as published by the FDA.

• InjurySep 21, 2026Inflation Problem

  It was reported that the patient was having trouble inflating the cylinders and that the cylinders of the Inflatable Penile Prosthesis (IPP) were not rigid enough for sex. As a result, the LGX was replaced for a more rigid CX. No patient complications were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50841987 ↗
• InjuryAug 5, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a patient with an Inflatable Penile Prosthesis (IPP) developed an infection. Antibiotic wash out was performed. The device IPP was removed and replaced. No further patient complications were reported.

  Patient problems: Unspecified Infection

  MAUDE report 50136711 ↗
• InjuryJun 2, 2026Fluid/Blood Leak; Inflation Problem; Material Puncture/Hole

  IT WAS REPORTED THAT AN INFLATABLE PENILE PROSTHESIS (IPP) EXHIBITED FLUID LOSS, AND THE PATIENT WAS UNABLE TO INFLATE THE DEVICE. A SURGICAL PROCEDURE WAS PERFORMED, DURING WHICH THE TUBING WAS IDENTIFIED AS BROKEN AT THE SUTURE SITE. AS A RESULT, THE IPP WAS REMOVED AND REPLACED. NO COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25368530 ↗
• InjuryMar 5, 2026Inflation Problem

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) WAS NOT RIGID ENOUGH AND THE PATIENT REQUESTED REVISION OF THE DEVICE. A SURGICAL PROCEDURE WAS PERFORMED IN WHICH THE EXISTING DEVICE WAS EXPLANTED AND REPLACED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24527446 ↗
• InjuryNov 11, 2025Nonstandard Device; Material Puncture/Hole; Nonstandard Device; Material Puncture/Hole

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) PRESENTED THE CYLINDERS RUPTURED. THE IPP WAS REMOVED AND REPLACED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23521878 ↗
• InjurySep 10, 2025Migration; Migration

  IT WAS REPORTED THAT THE PATIENT WITH THIS INFLATABLE PENILE PROSTHESIS (IPP) STATED THAT THE BULB WAS POSITIONED AT THE TOP OF THE SCROTUM AND FELT AS THOUGH THE RIGHT TESTICLE WAS ATTACHED TO IT. THE PATIENT ALSO REPORTED THAT THE BULB APPEARED TO BE AFFIXED TO THE SCROTUM. THE DEVICE REMAINS IMPLANTED, AND THE PATIENT WAS ADVISED TO FOLLOW UP WITH HIS PHYSICIAN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Adhesion(s)

  MAUDE report 23015484 ↗
• InjuryJul 18, 2025Mechanical Problem; Nonstandard Device; Material Puncture/Hole; Mechanical Problem; Nonstandard Device; Material Puncture/Hole

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) WAS NOT PERFORMING AS EXPECTED. TWO WEEKS LATER A REVISION SURGERY WAS PERFORMED, UPON EXAMINATION A CRACK IN THE RIGHT CYLINDER CONNECTING TUBE WAS FOUND. THE PUMP AND RIGHT CYLINDER WERE EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22543472 ↗
• InjuryJul 14, 2025Inflation Problem; Material Puncture/Hole; Inflation Problem; Material Puncture/Hole

  IT WAS REPORTED THAT THE PATIENT WITH THIS INFLATABLE PENILE PROSTHESIS (IPP) INDICATED THAT THE CYLINDERS WERE NOT INFLATING COMPLETELY, RESULTING IN INSUFFICIENT RIGIDITY. DURING THE EXPLANT PROCEDURE, A HOLE WAS DISCOVERED IN THE LEFT CYLINDER. IT IS ALSO BELIEVED THE PATIENT MAY BE USING PENILE INJECTIONS IN AN ATTEMPT TO ACHIEVE GREATER RIGIDITY. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22501956 ↗
• InjuryJul 1, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) THE SCROTAL PUMP TUBING WAS KINKED IN TWO PLACES TOWARDS THE RESERVOIR. THE PROXIMAL KINK WAS VERY NEAR THE NECK. THE ENTIRE TUBING WAS REPLACED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22370317 ↗
• InjuryApr 25, 2025Fluid/Blood Leak; Adverse Event Without Identified Device or Use Problem; Fluid/Blood Leak; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) PRESENTED TO 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 21910654 ↗
• InjuryJan 14, 2025Fluid/Blood Leak; Material Puncture/Hole; Unintended Deflation; Fluid/Blood Leak; Material Puncture/Hole; Unintended Deflation

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) PRESENTED WITH DEFLATION ISSUES. THE PATIENT STATED THAT DURING INTERCOURSE, HIS IMPLANT WOULD START TO DEFLATE. FLUID LOSS DUE TO A HOLE IN ONE SIDE OF THE CYLINDERS WAS NOTED. THE IPP WAS EXPLANTED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21153925 ↗
• InjuryJan 8, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) STOPPED WORKING. IT IS UNKNOWN WHAT CAUSED THE DEVICE ISSUE. A SURGICAL PROCEDURE WAS PERFORMED DURING WHICH THE EXISTING IPP WAS REMOVED AND REPLACED WITH A NEW ONE. THE PATIENT IS EXPECTED TO FULLY RECOVER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21101342 ↗
• InjuryJan 2, 2025Mechanical Problem; Migration; Mechanical Problem; Migration

  IT WAS REPORTED THAT THE RESERVOIR OF THIS INFLATABLE PENILE PROSTHESIS (IPP) MIGRATED FROM INGUINAL CANAL TO SUBMUSCULAR SPACE. IT WAS NOTICED THE PUMP WAS STICKY. THE IPP WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21064056 ↗
• InjuryNov 22, 2024Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS STOPPED WORKING. THE DEVICE WAS REMOVED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20756913 ↗
• InjuryNov 18, 2024Fluid/Blood Leak; Mechanical Problem; Material Deformation; Fluid/Blood Leak; Mechanical Problem; Material Deformation

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS WAS NOT WORKING PROPERLY AND HAD FLUID LOSS. THE DEVICE HAD KINK IN THE TUBING. THE DEVICE WAS REMOVED, AND THE PATIENT WAS IMPLANTED WITH TENACIO. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20711534 ↗
• InjurySep 27, 2024Fluid/Blood Leak; Inflation Problem; Mechanical Problem; Fluid/Blood Leak; Inflation Problem; Mechanical Problem

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) WOULD NOT STAY INFLATED DURING USE. THE PATIENT WAS ASSESSED IN OFFICE AND THE PUMP DID NOT ACTIVATE DURING INITIAL SQUEEZE. THE IMPLANT WOULD INFLATE, BUT LOSE FLUID ONCE INFLATED. TROUBLESHOOTING MEASURES WERE PERFORMED BUT WERE NOT SUCCESSFUL AND THE PATIENT WAS NOT COMFORTABLE DURING THIS STEP. IT WAS SUGGESTED TO THE PATIENT TO TRY IT HIMSELF AT HOME AND SEE IF THE SITUATION RESOLVED. THE IPP IS CURRENTLY IMPLANTED. THERE IS NO ADDITIONAL INFORMATION REPORTED.

  Patient problems: Discomfort

  MAUDE report 20322565 ↗
• InjurySep 4, 2024Fluid/Blood Leak; Mechanical Problem; Material Puncture/Hole; Fluid/Blood Leak; Mechanical Problem; Material Puncture/Hole

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) STOPPED WORKING DUE TO FLUID LOSS CAUSED BY A HOLE. A SURGICAL PROCEDURE WAS PERFORMED TO REMOVE AND REPLACE ALL THE COMPONENTS. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20134833 ↗
• InjuryMay 14, 2024Fluid/Blood Leak; Inflation Problem; Fluid/Blood Leak; Inflation Problem

  IT WAS REPORTED THAT THE PATIENT WITH THIS INFLATABLE PENILE PROSTHESIS (IPP) EXPERIENCED INFLATION ISSUES. AT A LATER DATE, THE IPP WAS REPLACED WITH A NEW IPP. THE PHYSICIAN TESTED THE ORIGINAL DEVICE AFTER EXPLANT AND FOUND THAT THERE WAS A FLUID LEAK IN THE CYLINDER WALL NEAR THE TUBING. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19315732 ↗
• InjuryMay 14, 2024Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) WAS NOT PERFORMING AS EXPECTED DUE TO A FLUID LOSS SINCE THE CYLINDER WAS PUNCTURED BY THE PATIENT. THE IPP WAS EXPLANTED AND REPLACED IT WITH TACTRA. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19314960 ↗
• InjuryApr 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WITH THIS IMPLANTABLE PENILE PROSTHESIS EXPERIENCED RECURRENT CYLINDER EROSION. THE PATIENT HAD BEEN SEEN IN CLINIC AND WAS REFERRED TO ANOTHER UROLOGIST. THE PATIENT ADVOCATE WAS CALLING TO INQUIRE ABOUT NEXT STEPS. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Erosion

  MAUDE report 19076771 ↗
• InjuryApr 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WITH THIS IMPLANTABLE PENILE PROSTHESIS EXPERIENCED CYLINDER EROSION. A REVISION PROCEDURE WAS PERFORMED INCLUDING REPAIR OF THE LEFT CORPORAL BODY. THE DEVICE REMAINS IMPLANTED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Erosion

  MAUDE report 19076190 ↗
• InjuryApr 5, 2024Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS STOPPED WORKING. A SURGICAL PROCEDURE WAS PERFORMED TO REMOVE AND REPLACE ALL THE COMPONENTS. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19053141 ↗
• InjuryJan 18, 2024Inflation Problem; Mechanical Problem; Inflation Problem; Mechanical Problem

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS PUMP WAS REMOVED AS THE DEVICE WOULD NOT INFLATE DUE TO THE PUMP NOT TRANSFERRING FLUID. A NEW INFLATABLE PENILE PROSTHESIS PUMP WAS IMPLANTED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18535131 ↗
• InjuryJan 2, 2024Fluid/Blood Leak; Inflation Problem; Connection Problem; Fluid/Blood Leak; Inflation Problem; Connection Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED INFLATION ISSUES WITH THIS INFLATABLE PENILE PROSTHESIS (IPP). A REMOVAL SURGERY WAS PERFORMED, AND IT WAS NOTED THE TUBING CONNECTOR BETWEEN THE CYLINDER AND THE PUMP WAS DISCONNECTED, RESULTING IN A FLUID LOSS. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18432147 ↗
• InjuryDec 5, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT, DUE TO PREVIOUS INFLATABLE PENILE PROSTHESIS REVISION SURGERIES, THE PATIENT EXPERIENCED NERVE DAMAGE IN HIS GLANS. NO ADDITIONAL INFORMATION WAS REPORTED.

  Patient problems: Nerve Damage

  MAUDE report 18270587 ↗