AMS 700 LGX MS Pump 72404255Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00878953003634), received between Oct 4, 2018 and Oct 22, 2024 — classified as 9 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (7 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryOct 22, 2024Fluid/Blood Leak; Mechanical Problem; Defective Device; Material Deformation; Fluid/Blood Leak; Mechanical Problem; Defective Device; Material Deformation

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) STARTED TO LOSE RIGIDITY AFTER ABOUT A MONTH OF USE AND THE BULB OF THE PUMP WAS EMPTY. DURING THE INITIAL IMPLANT, THE PHYSICIAN MADE DOUBLE CONNECTIONS OF THIS IPP TO SHORTEN PUMP LENGTH. THE SECOND CONNECTION WASN'T MADE CORRECTLY SO THERE WAS A KINK IN THE TUBING. THE PUMP WAS EXPLANTED AND REPLACED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20506170 ↗
• InjurySep 4, 2024Inflation Problem; Mechanical Problem; Inflation Problem; Mechanical Problem

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) WOULD NOT INFLATE DUE TO THE PUMP NOT WORKING AS INTENDED. THE IPP WAS REPLACED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20137071 ↗
• InjuryNov 16, 2023Inflation Problem; Mechanical Problem; Inflation Problem; Mechanical Problem

  IT WAS REPORTED THAT PUMP AND CYLINDERS OF THIS INFLATABLE PENILE PROSTHESIS WERE NOT INFLATING AND DID NOT WORK. THE DEVICE WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18149457 ↗
• InjurySep 18, 2023Fluid/Blood Leak; Inflation Problem; Material Puncture/Hole; Defective Device; Air/Gas in Device; Fluid/Blood Leak; Inflation Problem; Material Puncture/Hole; Defective Device; Air/Gas in Device

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) WAS NOT FUNCTIONING PROPERLY DUE TO INFLATION ISSUES AND FLUID LEAKAGE. THE RESERVOIR WAS REPORTED TO BE FULL; THE PUMP WAS EMPTY AND PRESENTED A SMALL BUBBLE. ALSO, THE PUMP DID NOT SQUEEZE AND WAS NOT MOVING FLUID. BESIDES THAT, THE CYLINDER PRESENTED A HOLE; HOWEVER, THE PHYSICIAN SUSPECTED IT WAS MADE DURING THE REMOVAL OF THE DEVICE. THE DEVICE WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17770310 ↗
• MalfunctionNov 9, 2022Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE INFLATABLE PENILE PROSTHESIS (IPP) STOPPED WORKING. THE PATIENT HAS AN APPOINTMENT WITH THE PHYSICIAN TO DISCUSS A REPLACEMENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15760457 ↗
• InjuryApr 12, 2022Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED WITH A 12 CM LGX INFLATABLE PENILE PROSTHESIS (IPP) PLUS 3 CM REAR TIP EXTENDERS (RTES). THE PATIENT COMPLAINED OF PROSTHESIS LENGTH, INDICATING THAT IT WAS TOO SMALL. THE PHYSICIAN STATED THAT THE DEVICE WAS FULLY FUNCTIONAL BUT HE CAN GET A LARGER IMPLANT. A SURGERY WAS PERFORMED AND IT WAS DISCOVERED THAT THE PATIENT NOW WAS 1.5 CM LONGER. THE IPP WAS REMOVED AND A 15 CM LGX PLUS 1.5 CM RTES WAS IMPLANTED. THE ORIGINAL RESERVOIR WAS LEFT IN USED AND WAS CONNECTED TO THE NEW CYLINDERS AND PUMP. THE DEVICE WAS FUNCTIONAL AFTER SURGERY AND THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14088743 ↗
• InjuryMar 22, 2021Fluid/Blood Leak; Mechanical Problem; Material Puncture/Hole; Fluid/Blood Leak; Mechanical Problem; Material Puncture/Hole

  IT WAS REPORTED THAT THE INFLATABLE PENILE PROSTHESIS (IPP) DEVICE HAD PERFORMANCE ISSUES EIGHT YEARS AFTER IMPLANT. PHYSICIAN TRIED CYCLING THE DEVICE BUT NO TROUBLESHOOTING RESOLVED THE ISSUE. ALL COMPONENTS WERE EXPLANTED AND REPLACED. UPON EXPLANT, IT WAS IDENTIFIED THAT THE DEVICE HAD A FLUID LOSS DUE TO A HOLE IN THE TUBING TO CYLINDER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11541877 ↗
• MalfunctionSep 4, 2020Inflation Problem; Mechanical Problem; Inflation Problem; Mechanical Problem

  IT WAS REPORTED THAT THE INFLATABLE PENILE PROSTHESIS (IPP) DEVICE IS GOING TO BE REVISED ON A FUTURE DATE BECAUSE OVER THE LAST THREE MONTHS THE PATIENT HAS OBSERVED A "PROGRESSIVE LOSS OF PENILE STIFFNESS AND DIFFICULTY HANDLING THE PUMP AND INFLATING THE CYLINDERS." "PHYSICAL UROLOGICAL EXAMINATION SHOWS WELL-LOCATED SYSTEM COMPONENTS AND WITHOUT PHLOGISTIC SIGNS OR EXTERNAL DEFORMATIONS WITH FAILURE IN THE FILLING SYSTEM WHEN STARTING THE PUMP." AS A RESULT OF THE EXAMINATION THE SURGEON AS DECIDED TO DO A SURGICAL EXPLORATION OF THE DEVICE SYSTEM. IF NECESSARY, THE DEVICE WILL BE REPLACED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10496650 ↗
• MalfunctionMar 31, 2020Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE INFLATABLE PENILE PROSTHESIS (IPP) DEVICE IS GOING TO BE REVISED BECAUSE THEY HAVE BEEN UNABLE TO ACTIVATE THE PUMP SINCE THE DEVICE WAS ORIGINALLY IMPLANTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9908131 ↗
• InjuryJul 30, 2019Defective Device; Migration; Defective Device; Migration

  IT WAS REPORTED THAT PATIENT HAD INFLATABLE PENILE PROSTHESIS (IPP) IMPLANTED OVER 10 YEARS AGO, POST RADICAL PROSTATECTOMY FOR CANCER. OVER THE LAST 8-9 MONTHS, HE NOTED PAIN WHENEVER HE SAT DOWN. EXAMINATION REVEALED THE DEVICE HAD MIGRATED OUT OF POSITION. THE DEVICE WAS REMOVED AND A NEW ONE IMPLANTED. NO SIGNS OF INFECTION NOTED AT THE TIME OF SURGERY. THE SURGEON DESCRIBED IN HIS OPERATIVE REPORT THAT THE OLD IMPLANT HAD "RIDDEN UP ON THE RIGHT SIDE OVER THE PUBIC BONE." WHAT PROBLEM DID THE USER HAVE: DEVICE MALFUNCTION - THAT IS, THE DEVICE DID NOT DO WHAT IT WAS SUPPOSED TO DO. OTHER INFORMATION ABOUT THE PATIENT THAT MAY HAVE INFLUENCED THE OUTCOME OF THE EVENT: POSSIBLE AGE AND PREVIOUS SURGICAL INTERVENTION.

  Patient problems: Pain

  MAUDE report 8842970 ↗
• InjuryJan 7, 2019Inadequacy of Device Shape and/or Size; Migration; Inadequacy of Device Shape and/or Size; Migration

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INFLATABLE PENILE PROSTHESIS (IPP) REVISION SURGERY BECAUSE THE PUMP WAS RIDING HIGH IN THE RIGHT SCROTUM. THE SURGEON DECIDED TO EXPLANT, AND THEN RE-IMPLANT THE PUMP IN THE LEFT SCROTUM. DURING THE TRANSFER, IT BECAME APPARENT THAT THE PUMP TUBING WAS TOO SHORT. THE SURGEON THEN DECIDED TO REPLACE ONLY THE PUMP COMPONENT. THE EXPLANTED PUMP DID NOT MALFUNCTION. THE STATUS OF THE PATIENT AFTER THE PROCEDURE WAS NOT PROVIDED. FURTHER INFORMATION WAS REQUESTED BUT 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 8223217 ↗
• InjuryOct 4, 2018Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE INFLATABLE PENILE PROSTHESIS (IPP) STOPPED WORKING "A WHILE BACK". THE IPP PUMP WAS EXPLANTED DUE TO THE PUMP GETTING STUCK. FORCED DEFLATION DID NOT RESOLVE THE ISSUE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT. AS THE COMPLAINT COMPONENT REMAINS IMPLANTED AND THE PRODUCT RECORD REVIEW REVEALED NO ADDITIONAL INFORMATION RELATED TO THE COMPLAINT, AN OVERALL INVESTIGATION CONCLUSION CODE OF NO PROBLEM DETECTED WAS CHOSEN AS THE DEVICE PROBLEM CANNOT BE CONFIRMED. AS THE REPORTED PROBLEM COULD NOT BE CONFIRMED, THE EVENT CANNOT BE REPRODUCED OR SUBSTANTIATED; THEREFORE, NO ESCALATION TO NCEP, CAPA, OR SCAR IS REQUIRED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7936993 ↗