AMS 700 LGX MS Pump 72404252Recalls & reported problems

Summary

The FDA's MAUDE database contains 757 adverse event reports that list this exact device (DI 00878953003603), received between Aug 21, 2017 and Sep 25, 2026 — classified as 1 death, 684 injuries, 72 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (293 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 757 reports, in the reporter's own words as published by the FDA.

• InjurySep 25, 2026Fluid/Blood Leak; Mechanical Problem; Material Puncture/Hole; Air/Gas in Device

  Patient problems: Perforation

  MAUDE report 50899777 ↗
• InjurySep 23, 2026Collapse; Inflation Problem; Mechanical Problem

  It was reported that this Inflatable Penile Prosthesis (IPP) would not inflate properly, as the patient experienced issues with the pump not working well. The pump bulb was reported to stay flat. 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 50870441 ↗
• InjurySep 21, 2026Mechanical Problem; Nonstandard Device; Material Puncture/Hole

  It was reported that the patient was unable to cycle the cylinders and presented for revision surgery. During the procedure, the explanted cylinders were observed to have what appeared to be damage to the silicone layer. A replacement surgery was performed, and new cylinders were implanted. No patient complications were reported, and the patient is expected to fully recover.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50842884 ↗
• InjurySep 7, 2026Collapse; Fluid/Blood Leak; Inflation Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50650936 ↗
• InjurySep 4, 2026Fluid/Blood Leak; Inflation Problem; Material Puncture/Hole; Air/Gas in Device

  It was reported that the Inflatable Penile Prosthesis (IPP) would not inflate due to fluid loss. During revision surgery, a hole was visually identified in the tubing. A revision procedure was performed during which the original device was explanted and replaced. No further patient complications were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50616506 ↗
• InjurySep 4, 2026Inflation Problem; Mechanical Problem

  It was reported that the patient's Inflatable Penile Prosthesis (IPP) presented buckling of the cylinders and inflation issues. A surgical procedure was performed, during which the IPP was explanted and replaced. No further information was provided.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50613126 ↗
• InjuryAug 18, 2026Inflation Problem; Air/Gas in Device

  It was reported that this Inflatable Penile Prosthesis (IPP) was not inflating properly. Upon inspection, air in the pump was noticed. As a result the device was explanted and replaced. No patient complications were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50311737 ↗
• InjuryAug 18, 2026Patient-Device Incompatibility

  It was reported that a patient with an Inflatable Penile Prosthesis (IPP) was unable to use the device since implantation due to lack of knowledge on how to operate it. In the course of a medical appointment the physician confirmed that the device was properly working, there were no leaks and the cylinders were inflated. The patient will undergo a device use education session. The device was explanted and replaced. There were no device issues or patient complications.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50308230 ↗
• InjuryAug 18, 2026Degraded

  It was reported that a patient with an Inflatable Penile Prosthesis (IPP) noticed a curvature when inflated the device, which was attributed to an aneurysm. A surgical procedure was performed to remove and replace the IPP. No further patient complications were reported.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 50306525 ↗
• InjuryAug 4, 2026Fluid/Blood Leak; Mechanical Problem; Material Puncture/Hole

  It was reported that an Inflatable Penile Prosthesis (IPP) stopped functioning. A surgical procedure was performed, during which a small break was identified in the tubing between the pump and one cylinder. This was identified as the site of the leak, as no fluid remained within the device. As a result, the entire IPP system was removed and replaced. Additionally, the physician inadvertently created a hole in one cylinder during device removal. No patient complications were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50128734 ↗
• InjuryJul 7, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WITH THIS INFLATABLE PENILE PROSTHESIS (IPP) EXPERIENCED PAIN UPON ACTIVATION OF THE DEVICE. DURING REVISION SURGERY, THE PHYSICIAN CONFIRMED THE PRESENCE OF INFECTION. THE DEVICE WAS EXPLANTED AND REPLACED WITH A MALLEABLE PENILE PROSTHESIS. THERE WERE NO FURTHER PATIENT COMPLICATIONS.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 25742690 ↗
• InjuryJun 25, 2026Degraded

  IT WAS REPORTED THAT THE CYLINDER OF THIS INFLATABLE PENILE PROSTHESIS (IPP) HERNIATED. AS A RESULT, THE DEVICE WAS EXPLANTED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25631411 ↗
• InjuryJun 17, 2026Fluid/Blood Leak; Inflation Problem; Material Puncture/Hole; Connection Problem

  IT WAS REPORTED THAT THE PATIENT'S INFLATABLE PENILE PROSTHESIS (IPP) EXHIBITED INFLATION ISSUES. A SURGICAL PROCEDURE WAS PERFORMED DURING WHICH IT WAS IDENTIFIED A FLUID LOSS DUE TO A TUBING DISCONNECTION AND BOTH CYLINDERS RUPTURED REPORTED FROM WEAR AND TEAR. THE IPP WAS EXPLANTED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25535438 ↗
• InjuryJun 1, 2026Fluid/Blood Leak; Material Puncture/Hole

  IT WAS REPORTED THAT THE INFLATABLE PENIS PROSTHESIS (IPP) PRESENTED WITH FLUID LOSS. A SURGICAL PROCEDURE WAS PERFORMED, AND THE DEVICE WAS REMOVED AND REPLACED WITH NEW HARDWARE. IT WAS DETERMINED THAT THE RIGHT CYLINDER HAD AN OUT-LAYER BREAK CAUSING THE DEVICE MALFUNCTION. NO COMPLICATIONS HAVE BEEN REPORTED AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25350631 ↗
• InjuryMay 27, 2026Fluid/Blood Leak; Inflation Problem; Material Puncture/Hole; Air/Gas in Device

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) WAS NOT INFLATING. UPON INSPECTION, A HOLE IN THE TUBING ON THE RIGHT SIDE OF THE CYLINDERS, AIR IN THE SYSTEM, AND ASSOCIATED FLUID LOSS WERE NOTED. AS A RESULT, THE DEVICE WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25305989 ↗
• InjuryMay 22, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WITH AN INFLATABLE PENILE PROSTHESIS (IPP) COMPLAINED OF PAIN. A REVISION SURGERY WAS PERFORMED, DURING WHICH THE PHYSICIAN STATED THAT UPON OPENING THE SCROTUM, PURULENT MATERIAL WAS IDENTIFIED WITH AN INFECTION LOCATED IN THE SCROTAL AREA EXTENDING TO THE CYLINDERS. THE PHYSICIAN REMOVED ALL COMPONENTS OF THE PREVIOUS IPP AND PERFORMED A WASHOUT WITH ANTIBIOTICS. THERE WERE NO FURTHER PATIENT COMPLICATIONS.

  Patient problems: Pain; Purulent Discharge; Unspecified Infection

  MAUDE report 25256598 ↗
• InjuryApr 30, 2026Collapse; Fluid/Blood Leak; Inflation Problem; Material Puncture/Hole; Air/Gas in Device

  IT WAS REPORTED THAT THE PATIENT'S INFLATABLE PENILE PROSTHESIS (IPP) EXHIBITED INFLATION ISSUES. DURING A SUBSEQUENT SURGICAL PROCEDURE, FLUID LOSS WAS IDENTIFIED AND ATTRIBUTED TO A HOLE IN THE TUBING, WHICH WAS NOTED TO BE RELATED TO THE AGE AND LONGEVITY OF THE DEVICE. ADDITIONALLY, AIR WAS OBSERVED WITHIN THE DEVICE, AND THE PUMP WAS FOUND TO BE COLLAPSED. THE IPP WAS FULLY REMOVED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25048853 ↗
• InjuryApr 28, 2026Inflation Problem; Mechanical Problem; Nonstandard Device

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) EXHIBITED INFLATION/DEFLATION ISSUES, AND THE PUMP WAS NOT WORKING. 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 25021255 ↗
• InjuryApr 17, 2026Fluid/Blood Leak; Mechanical Problem

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) IMPLANT DEVICE WAS NON-FUNCTIONING. A SURGICAL PROCEDURE WAS PERFORMED DURING WHICH THE DEVICE WAS EXPLANTED AND REPLACED. UPON EXPLANT, THE PHYSICIAN IDENTIFIED FLUID LOSS. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24915994 ↗
• InjuryApr 8, 2026Fluid/Blood Leak; Inflation Problem

  IT WAS REPORTED THAT AN INFLATABLE PENILE PROSTHESIS (IPP) EXHIBITED INFLATION ISSUES, AND THE RESERVOIR WAS FOUND TO BE EMPTY, INDICATING FLUID LOSS. HOWEVER, THE SOURCE AND LOCATION OF THE LEAK ARE UNKNOWN. A SURGICAL PROCEDURE WAS PERFORMED TO REMOVE AND REPLACE THE IPP. NO COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24824514 ↗
• InjuryApr 2, 2026Fluid/Blood Leak; Inflation Problem

  IT WAS REPORTED THAT THE PATIENT WITH AN INFLATABLE PENILE PROSTHESIS (IPP) WAS UNABLE TO INFLATE THE DEVICE DUE TO FLUID LOSS. 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 24765913 ↗
• InjuryFeb 27, 2026Fluid/Blood Leak; Mechanical Problem

  IT WAS REPORTED THAT THE PATIENT WITH THIS INFLATABLE PENILE PROSTHESIS (IPP) WAS EXPERIENCING ISSUES WITH THE IMPLANT NOT FUNCTIONING PROPERLY. FLUID LOSS WAS IDENTIFIED. 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 24467165 ↗
• InjuryFeb 17, 2026Deflation Problem; Fluid/Blood Leak; Inflation Problem; Material Puncture/Hole

  IT WAS REPORTED THAT THE PATIENT'S INFLATABLE PENILE PROSTHESIS (IPP) REQUIRED A REVISION SURGERY ONE MONTH AFTER IMPLANTATION DUE TO THE PUMP DID NOT RESPOND TO EITHER INFLATION OR DEFLATION ATTEMPTS. DURING THE PROCEDURE, THE SURGEON IDENTIFIED A CUT ON ONE OF THE CYLINDERS, WHICH WAS FILLED WITH BLOOD. THE ENTIRE IPP WAS SUBSEQUENTLY REMOVED, AND NO NEW DEVICE WAS IMPLANTED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24371153 ↗
• InjuryFeb 2, 2026Fluid/Blood Leak; Mechanical Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24233070 ↗
• InjuryJan 5, 2026Fluid/Blood Leak; Air/Gas in Device

  IT WAS REPORTED THAT THE PATIENT WITH A HISTORY OF ERECTILE DYSFUNCTION AND AN INFLATABLE PENILE PROSTHESIS (IPP) IMPLANT DEVICE NOTED THAT THE DEVICE WAS NOT WORKING AS THERE WAS FLUID LOSS. THE FLUID LOSS WAS IDENTIFIED BY THERE BEING AIR IN THE PUMP. THE PHYSICIAN REMOVED AND REPLACED THE ENTIRE DEVICE THROUGH REPLACEMENT SURGERY, AND THERE WERE NO PATIENT SIGNS OR SYMPTOMS REPORTED AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23968850 ↗