AMS 700 LGX MS Pump 72404252-10Recalls & reported problems

Summary

The FDA's MAUDE database contains 561 adverse event reports that list this exact device (DI 00878953009810), received between Oct 19, 2018 and Sep 30, 2026 — classified as 483 injuries, 78 malfunctions.

The most frequently reported specific device problem is “Inflation Problem” (155 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 561 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Mechanical Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50953783 ↗
• InjurySep 10, 2026Degraded; Material Puncture/Hole; Inadequacy of Device Shape and/or Size

  It was reported that the patient with this Inflatable Penile Prosthesis (IPP) experienced pain and discomfort inside the corporal bodies. Upon inspection, wear of the outer layer of the cylinders was identified, resulting in cylinder buckling. A potencial oversizing of the device or a weak point in the patient corporal body were the possible causes of the discomfort. As a result, the cylinders and pump were explanted and replaced. No further patient complications were reported.

  Patient problems: Discomfort; Pain

  MAUDE report 50714892 ↗
• InjurySep 7, 2026Fluid/Blood Leak; Mechanical Problem; Material Puncture/Hole

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50650182 ↗
• InjurySep 4, 2026Inflation Problem

  It was reported that this Inflatable Penile Prosthesis (IPP) was not able to fully inflate. A surgical procedure was performed during which the entire device was explanted and replaced. There were no patient complications reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50602393 ↗
• InjuryAug 28, 2026Mechanical Problem; Connection Problem

  It was reported that the patient his Inflatable Penile Prosthesis (IPP) had a reservoir disconnection and was not able to pump act. The patient underwent surgery and the device was explanted. There were no patient complications.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unspecified Infection

  MAUDE report 50508658 ↗
• MalfunctionAug 20, 2026Deflation Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50349138 ↗
• InjuryAug 14, 2026Insufficient Device Problem Information

  Patient problems: Unspecified Infection

  MAUDE report 50261956 ↗
• InjuryAug 11, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a patient with an Inflatable Penile Prosthesis (IPP) experienced irritation at the pump site. A surgical procedure was performed to remove and replace the pump. No further patient complications were reported.

  Patient problems: Tissue Irritation

  MAUDE report 50213579 ↗
• InjuryAug 4, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a patient with an Inflatable Penile Prosthesis (IPP) developed a scrotal infection. The patient reportedly used the device prior to completion of the recommended healing period and reportedly engaged in substance use. No device issues were reported. The IPP was removed and replaced with a Tactra device. No further patient complications were reported.

  Patient problems: Unspecified Infection

  MAUDE report 50128087 ↗
• InjuryJul 29, 2026Fluid/Blood Leak; Inflation Problem; Mechanical Problem; Material Puncture/Hole

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50070329 ↗
• InjuryJul 22, 2026Migration

  IT WAS REPORTED THAT THE PATIENT IMPLANTED WITH THIS INFLATABLE PENILE PROSTHESIS (IPP) EXPERIENCED LOWER ABDOMINAL PAIN. A SURGICAL PROCEDURE WAS PERFORMED, DURING WHICH THE RESERVOIR WAS FOUND TO HAVE HERNIATED OUT OF THE SPACE OF RETZIUS. THE RESERVOIR WAS REPLACED WITH A NEW CONCEAL RESERVOIR, WHILE THE CYLINDERS AND PUMP WERE INSPECTED AND FOUND TO BE INTACT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY, AND NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Pain

  MAUDE report 25905908 ↗
• InjuryJul 16, 2026Collapse; Fluid/Blood Leak; Inflation Problem; Material Puncture/Hole

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) WOULD NOT INFLATE AND THE PUMP WOULD STAY FLAT. A SURGICAL PROCEDURE WAS PERFORMED DURING WHICH THE ENTIRE DEVICE WAS EXPLANTED AND REPLACED. UPON EXPLANT THE PHYSICIAN IDENTIFIED A HOLE IN THE RESERVOIR TUBING AND FLUID LEAKAGE. THE NEW DEVICE WAS TESTED AND WAS FULLY FUNCTIONAL. THE PATIENT FULLY RECOVERED, AND THERE WAS NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25850267 ↗
• InjuryJul 7, 2026Inflation Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25740403 ↗
• InjuryJun 12, 2026Inflation Problem; Nonstandard Device

  It was reported that an Inflatable Penile Prosthesis (IPP) stopped inflating. 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 25488773 ↗
• InjuryJun 10, 2026Migration

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH AN INFLATABLE PENILE PROSTHESIS (IPP) EXPERIENCED PAIN AND DISCOMFORT NEAR THE GLANS. A SURGICAL PROCEDURE WAS PERFORMED, DURING WHICH IT WAS DETERMINED THAT THE LEFT CYLINDER HAD SLIGHTLY MIGRATED DOWNWARD, RESULTING IN PATIENT DISCOMFORT. THE IPP WAS SUBSEQUENTLY REPLACED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Discomfort; Pain

  MAUDE report 25461045 ↗
• InjuryMay 29, 2026Mechanical Problem; Material Puncture/Hole

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) WAS NOT WORKING. A SURGICAL PROCEDURE WAS PERFORMED DURING WHICH THE DEVICE WAS EXPLANTED AND REPLACED. UPON EXPLANT THE PHYSICIAN IDENTIFIED A HOLE IN ONE OF THE CYLINDERS. THE PHYSICIAN SUSPECTED THE MOST LIKELY CAUSE WAS WEAR AND TEAR. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25340696 ↗
• InjuryMay 21, 2026Migration

  IT WAS REPORTED THAT A PATIENT WITH AN INFLATABLE PENILE PROSTHESIS (IPP) PRESENTED WITH THE PUMP PULLED UP FROM ITS ORIGINAL POSITION. A REVISION SURGERY WAS PERFORMED, DURING WHICH THE PHYSICIAN EXPLANTED AND REPLACED THE DEVICE. THE ORIGINAL IMPLANT LOCATION WAS ESTIMATED TO BE APPROXIMATELY THREE QUARTERS OF AN INCH FROM ITS OBSERVED POSITION AND SLIGHTLY RIGHT OF MIDLINE BY APPROXIMATELY 2 CM, WITH THE RESERVOIR ON THAT SIDE. THE REPLACEMENT PUMP WAS IMPLANTED IN A NEW POCKET AT LEAST ONE INCH BELOW THE PRIOR LOCATION AND POSITIONED MIDLINE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25250414 ↗
• InjuryMay 19, 2026Inflation Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25222647 ↗
• InjuryMay 13, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS PATIENT WITH AN INFLATABLE PENILE PROSTHESIS (IPP) EXPERIENCED AN INFECTION. A SURGICAL PROCEDURE WAS PERFORMED DURING WHICH THE DEVICE WAS EXPLANTED. THERE WERE NO DEVICE ISSUES AND THERE WERE NO FURTHER PATIENT COMPLICATIONS REPORTED.

  Patient problems: Unspecified Infection

  MAUDE report 25164861 ↗
• InjuryMay 12, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS PATIENT WITH AN INFLATABLE PENILE PROSTHESIS (IPP) HAD AN INFECTION FOR OVER A YEAR WHICH WAS BEING TREATED WITH ANTIBIOTICS FROM THEIR PREVIOUS SURGEON. THE PATIENT ALSO EXPERIENCED PAIN. A SURGICAL PROCEDURE WAS PERFORMED DURING WHICH THE DEVICE WAS REMOVED, AND THE PHYSICIAN COMPLETED A WASHOUT AND PLACE A MALLEABLE DEVICE IN ORDER TO HOLD THE CORPRA SPACE OPEN. THERE WERE NO FURTHER PATIENT COMPLICATIONS REPORTED.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 25153655 ↗
• InjuryMay 7, 2026Nonstandard Device

  IT WAS REPORTED THAT DURING THE INITIAL PLACEMENT OF AN INFLATABLE PENILE PROSTHESIS (IPP), A DISTAL CORPORAL PERFORATION OCCURRED, WHICH RESULTED IN THE PLACEMENT OF ONLY ONE CYLINDER. FOLLOWING THE PROCEDURE, THE PATIENT DID NOT ACHIEVE SATISFACTORY OUTCOMES WITH THE IMPLANT. CONSEQUENTLY, A SUBSEQUENT SURGICAL INTERVENTION WAS PERFORMED. DURING THIS PROCEDURE, THE PREVIOUSLY PLACED SINGLE CYLINDER WAS REMOVED AND REPLACED WITH TWO NEW CYLINDERS AND A PUMP. THE ORIGINAL RESERVOIR WAS RETAINED, DRAINED AND SUBSEQUENTLY REFILLED. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Perforation

  MAUDE report 25116543 ↗
• InjuryMay 7, 2026Mechanical Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25111694 ↗
• InjuryMay 6, 2026Malposition of Device

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) PUMP WAS PLACED TOO DEEP POSTERIORLY IN THE SCROTUM MAKING IT DIFFICULT TO USE. A SURGICAL PROCEDURE WAS PERFORMED DURING WHICH THE PUMP WAS REMOVED AND REPLACED WITH A NEW PUMP IN A BETTER LOCATION. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25099580 ↗
• InjuryApr 29, 2026Inflation Problem

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) WAS NOT INFLATING. AS A RESULT, THE CYLINDERS AND PUMP WERE EXPLANTED AND REPLACED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25032185 ↗
• InjuryApr 23, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WITH AN INFLATABLE PENILE PROSTHESIS (IPP) PRESENTED WITH AN INFECTION, WITH PUS NOTED FROM THE INCISION SITE AND ASSOCIATED SCROTAL EDEMA DURING A PHYSICIAN CONSULTATION. A REVISION SURGERY WAS PERFORMED, DURING WHICH THE DEVICE WAS EXPLANTED, AND THE SURGICAL SITE WAS IRRIGATED WITH ANTIBIOTICS, AFTER WHICH A MALLEABLE DEVICE WAS PLACED. THERE WERE NO FURTHER PATIENT COMPLICATIONS.

  Patient problems: Purulent Discharge; Swelling/ Edema; Unspecified Infection

  MAUDE report 24974026 ↗