AMS 700 LGX MS Pump 72404250Recalls & reported problems

Summary

The FDA's MAUDE database contains 49 adverse event reports that list this exact device (DI 00878953003580), received between Nov 28, 2018 and Sep 28, 2026 — classified as 47 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (17 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 49 reports, in the reporter's own words as published by the FDA.

• InjurySep 28, 2026Fluid/Blood Leak; Inflation Problem; Material Puncture/Hole; Air/Gas in Device

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50926217 ↗
• InjurySep 23, 2026Mechanical Problem

  It was reported that a patient with an Inflatable Penile Prosthesis (IPP) had a device no longer functioning. A revision procedure was done to explant and replace the device. No further patient complications were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50867421 ↗
• InjuryAug 24, 2026Insufficient Device Problem Information

  It was reported that a patient with an Inflatable Penile Prosthesis (IPP) experienced scrotal erosion at the pump site, as well as erosion of the left cylinder. A surgical procedure was performed to remove the IPP and replace it with a Tactra. No further patient complications were reported.

  Patient problems: Erosion

  MAUDE report 50415924 ↗
• InjuryAug 5, 2026Migration

  It was reported that the pump of this Inflatable Penile Prosthesis (IPP) crossed over and the patient experienced discomfort. As a result, the cylinder and pump were explanted and replaced. The reservoir was left in the patient. No further patient complications were reported.

  Patient problems: Discomfort

  MAUDE report 50150279 ↗
• InjuryApr 6, 2026Degraded

  IT WAS REPORTED THAT THE CYLINDER OF THIS INFLATABLE PENILE PROSTHESIS (IPP) PRESENTED A BULGE. THE CYLINDER WAS EXPLANTED AND REPLACED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24792325 ↗
• InjuryJan 28, 2026Degraded; Mechanical Problem

  IT WAS REPORTED THAT THE PATIENT WITH AN INFLATABLE PENILE PROSTHESIS (IPP) EXPERIENCED CYLINDER EROSION, DISCOMFORT AND THE DEVICE WAS NOT WORKING AS EXPECTED AS THE CYLINDER HAD AN ANEURYSM. A SURGICAL PROCEDURE WAS PERFORMED TO REMOVE AND REPLACE THE IPP. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Discomfort; Erosion

  MAUDE report 24201525 ↗
• InjuryJul 22, 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) WAS EXPERIENCING A CHRONIC INFECTION. A SURGICAL PROCEDURE WAS PERFORMED IN WHICH THE DEVICE WAS REMOVED, A WASHOUT WAS PERFORMED, AND A MALLEABLE IMPLANT WAS PLACED. THERE WERE NO FURTHER PATIENT COMPLICATIONS REPORTED.

  Patient problems: Unspecified Infection

  MAUDE report 22571590 ↗
• InjuryJun 5, 2025Inadequacy of Device Shape and/or Size; Migration; Inadequacy of Device Shape and/or Size; Migration

  IT WAS REPORTED THAT THE RESERVOIR OF THIS INFLATABLE PENILE PROSTHESIS (IPP) HERNIATED, AND THE CYLINDERS WERE TOO SHORT. 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 22149719 ↗
• InjuryMay 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WITH THIS INFLATABLE PENILE PROSTHESIS (IPP) WAS NOT SATISFIED WITH THE PUMP OF THE DEVICE. IT WAS NOTED THAT THE PATIENT EXPERIENCED DISCOMFORT AND PAIN EVEN AFTER MULTIPLE ADJUSTMENTS WERE ATTEMPTED. A SURGICAL PROCEDURE WAS PERFORMED IN WHICH THE EXISTING DEVICE WAS EXPLANTED. THERE WERE NO FURTHER PATIENT COMPLICATIONS REPORTED.

  Patient problems: Discomfort; Pain

  MAUDE report 22077969 ↗
• InjuryFeb 13, 2025Inflation Problem; Mechanical Problem; Inflation Problem; Mechanical Problem

  IT WAS REPORTED THAT THE PATIENT WITH THIS INFLATABLE PENILE PROSTHESIS WAS NOT ABLE TO FILL THE PROSTHESIS COMPLETELY FOR 6 MONTHS, THE CYLINDERS WERE NOT COMPLETELY FILLED, AND HE WAS NOT ABLE TO ACHIEVE FULL ERECTION. THE DEVICE IS STILL IMPLANTED. NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21375469 ↗
• InjuryFeb 5, 2025Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT THE PATIENT WITH THIS INFLATABLE PENILE PROSTHESIS (IPP) WAS DISSATISFIED WITH THE DEVICE DUE TO IMPROPER SIZING AND MEASUREMENT BY THE PREVIOUS DOCTOR. A SURGICAL PROCEDURE WAS PERFORMED TO REMOVE THE EXISTING IPP AND REPLACE IT WITH ONE OF APPROPRIATE SIZE, KEEPING THE ORIGINAL RESERVOIR AND PLACING 18 CM CYLINDERS WITH 3 CM RTE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21312692 ↗
• InjuryNov 4, 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) PRESENTED AT THE FOUR WEEK FOLLOW UP WITH EROSION OF THE PUMP AND A HOLE IN THEIR SCROTUM. THE PHYSICIAN TESTED FOR INFECTION AND CONFIRMED ABNORMAL FINDINGS. THE PATIENT WAS PLACED ON ANTIBIOTICS FOR TWO WEEKS, AND THEN PERFORMED A WASH OUT AND REPLACED THE PUMP. ANOTHER SWAB FOR INFECTION WAS PERFORMED AND RETURNED AS NORMAL. THERE WERE NO ADDITIONAL PATIENT COMPLICATIONS REPORTED.

  Patient problems: Erosion; Unspecified Infection

  MAUDE report 20599079 ↗
• InjuryApr 22, 2024Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole

  IT WAS REPORTED THAT THE LEFT CYLINDER OF THE INFLATABLE PENILE PROSTHESIS RUPTURED AND THE DEVICE EXHIBITED FLUID LOSS. THE DEVICE WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19161080 ↗
• InjuryMar 23, 2024Inadequacy of Device Shape and/or Size; Defective Device; Malposition of Device; Inadequacy of Device Shape and/or Size; Defective Device; Malposition of Device

  IT WAS REPORTED THAT THE PATIENT STATED THIS INFLATABLE PENILE PROSTHESIS WAS TOO SHORT AND THE PUMP WAS DIFFICULT TO REACH. IN ADDITION, THE PATIENT FELT LIKE THE DISTAL TIPS WERE NOT PLACED PROPERLY. A SURGICAL PROCEDURE WAS PERFORMED TO REMOVE AND REPLACE CYLINDERS AND PUMP. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18966298 ↗
• InjuryMar 23, 2024Fluid/Blood Leak; Mechanical Problem; Material Puncture/Hole; Inadequacy of Device Shape and/or Size; Defective Device; Fluid/Blood Leak; Mechanical Problem; Material Puncture/Hole; Inadequacy of Device Shape and/or Size; Defective Device

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS STOPPED WORKING AS THE PATIENT COULD NOT PUMP THE DEVICE. A SURGICAL PROCEDURE WAS PERFORMED, DURING WHICH FLUID LOSS CAUSED BY A HOLE IN THE CYLINDER TUBING WAS IDENTIFIED. IN ADDITION, IT WAS NOTED THAT THE IMPLANT WAS SIGNIFICANTLY SMALLER THAN WHAT WAS MEASURED. ALL COMPONENTS WERE REMOVED AND REPLACED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18966234 ↗
• InjuryMar 11, 2024Inflation Problem; Mechanical Problem; Inflation Problem; Mechanical Problem

  IT WAS REPORTED THAT THE PUMP OF THIS INFLATABLE PENILE PROSTHESIS WAS NOT WORKING PROPERLY, AND THE CYLINDERS WERE NOT REMAINING INFLATED. 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 18882930 ↗
• InjuryJan 22, 2024Fluid/Blood Leak; Mechanical Problem; Material Puncture/Hole; Fluid/Blood Leak; Mechanical Problem; Material Puncture/Hole

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS WAS NOT WORKING. THE DEVICE HAD FLUID LOSS. IT WAS IDENTIFIED THAT THE LEFT TUBING WHICH WAS CONNECTED TO THE PUMP WAS BROKEN. THE ENTIRE DEVICE WAS REPLACED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18554975 ↗
• InjuryFeb 14, 2023Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole

  IT WAS REPORTED THAT THE PATIENT UNDERWENT SURGICAL INTERVENTION TO EXPLANT THE INFLATABLE PENILE PROSTHESIS (IPP) DUE TO THE DEVICE NO LONGER FUNCTIONING. UPON EXPLANT, THE TUBING BETWEEN THE PUMP AND CYLINDERS WERE BROKEN AND THE DEVICE HAD LOST FLUID. A NEW IPP WAS IMPLANTED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16373554 ↗
• InjuryOct 28, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A SURGICAL PROCEDURE TO EXPLANT A PENILE PROSTHESIS FOR UNSPECIFIED REASONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15690975 ↗
• InjuryOct 25, 2022Mechanical Problem; Mechanical Problem

  IT WAS REPORTED BY THE PATIENT THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) HAD NOT BEEN FUNCTIONING PROPERLY SINCE IMPLANT. TROUBLESHOOTING TECHNIQUES WERE PROVIDED BY PATIENT SERVICES (PS); HOWEVER, THE PATIENT STATED THAT HE HAD TRIED THEM ALL WITHOUT SUCCESS. HE ALSO REPORTED PAIN IN THE PERINEUM AND RECTUM AND MENTIONED THAT HE HAS BEEN PASSING STONES. THE BOSTON SCIENTIFIC PS REPRESENTATIVE ENCOURAGED HIM TO GET CLINICAL EVALUATION. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Pain

  MAUDE report 15671555 ↗
• InjurySep 13, 2022Deflation Problem; Inflation Problem; Deflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INFLATABLE PENILE PROSTHESIS (IPP) REPLACEMENT SURGERY DUE TO INFLATION AND DEFLATION ISSUES. ALL COMPONENTS WERE REMOVED AND REPLACED WITH AN AMBICOR PENILE PROSTHESIS (APP). THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15412912 ↗
• InjuryAug 25, 2022Fluid/Blood Leak; Mechanical Problem; Fluid/Blood Leak; Mechanical Problem

  IT WAS REPORTED THAT THE PATIENT HAD THE INFLATABLE PENILE PROSTHESIS REMOVED AS IT STOPPED WORKING DUE TO A LEAK. THE PUMP WAS EMPTY UPON REMOVAL. A NEW INFLATABLE PENILE PROSTHESIS WAS IMPLANTED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15297039 ↗
• InjuryAug 22, 2022Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INFLATABLE PENILE PROSTHESIS (IPP) REPLACEMENT SURGERY BECAUSE THE DEVICE WAS NOT WORKING ANYMORE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15271811 ↗
• InjuryFeb 21, 2022Mechanical 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 UNDERWENT AN INFLATABLE PENILE PROSTHESIS (IPP) SURGERY DUE TO THE DEVICE NOT WORKING. IT WAS SAID THAT THE RIGHT CYLINDER WAS DISRUPTED. BOTH CYLINDERS OUTER LAYER DISLODGED FROM INNER FABRIC LAYER AND THE DACRON LAYER WAS TORN. THE DEVICE WAS REMOVED AND THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13573760 ↗
• InjuryFeb 15, 2022Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A SURGICAL PROCEDURE TO REMOVE THIS INFLATABLE PENILE PROSTHESIS (IPP) BECAUSE IT WAS NON-FUNCTIONING. THE EXISTING DEVICE WAS REMOVED AND REPLACED WITH AN AMBICOR PENILE PROSTHESIS (APP). NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13536052 ↗