AMS 700 LGX MS Pump 72404257Recalls & reported problems

Summary

The FDA's MAUDE database contains 400 adverse event reports that list this exact device (DI 00878953003658), received between Oct 10, 2018 and Sep 28, 2026 — classified as 358 injuries, 42 malfunctions.

The most frequently reported specific device problem is “Inflation Problem” (140 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 400 reports, in the reporter's own words as published by the FDA.

• InjurySep 28, 2026Degraded

  It was reported that patient wasn't satisfied with his Inflatable Penile Prosthesis (IPP). As a result, the device was explanted and replaced. A bulge was then noticed in the cylinder. No further patient complications were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50917389 ↗
• InjurySep 25, 2026Collapse; Inflation Problem; Material Puncture/Hole

  It was reported that this Inflatable Penile Prosthesis (IPP) stopped pumping up and stopped rebounding. A surgical procedure was performed during which the entire device was explanted and replaced with a malleable device. Upon explant the physician observed the right cylinder had a small pinhole. The physician believed the patient may have attempted augmenting themselves post-surgery. There were no patient complications reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50899150 ↗
• InjuryAug 12, 2026Inflation Problem

  It was reported that this Inflatable Penile Prosthesis (IPP) presented inflation issues. A surgical procedure was performed during which the existing device was explanted and replaced with a new IPP. There were no patient complications reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50229913 ↗
• InjuryJul 29, 2026Nonstandard Device; Inadequacy of Device Shape and/or Size

  It was reported that the patient with this Inflatable Penile Prosthesis (IPP) was complaining on the length and feeling the tubing. As a result, the cylinders and pump were explanted and replaced. No patient complications were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50072301 ↗
• InjuryJul 14, 2026Fluid/Blood Leak; Material Puncture/Hole

  IT WAS REPORTED THAT THE PATIENT'S INFLATABLE PENILE PROSTHESIS (IPP) EXHIBITED INFLATION ISSUES. A COMPUTED TOMOGRAPHY (CT) SCAN INDICATED THAT THE RESERVOIR CONTAINED NO FLUID. A SURGICAL PROCEDURE WAS PERFORMED DURING WHICH A TEAR IN THE LEFT CYLINDER WAS IDENTIFIED. THE RESERVOIR WAS ALLOWED TO DRAIN AND WAS RETAINED, AND A NEW RESERVOIR WAS IMPLANTED. THE RECONNECT WAS ALSO REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25818450 ↗
• MalfunctionJun 12, 2026Deflation Problem

  IT WAS REPORTED THAT DURING THE TEST PERIOD, ONE OF THE CYLINDERS OF THIS INFLATABLE PENILE PROSTHESIS (IPP) WOULD NOT DEFLATE. TROUBLESHOOTING WAS PERFORMED BUT WAS UNSUCCESSFUL; THEREFORE, THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25488756 ↗
• InjuryJun 4, 2026Mechanical Problem; Nonstandard Device

  IT WAS REPORTED THAT AN INFLATABLE PENILE PROSTHESIS (IPP) EXHIBITED LOCK-OUT VALVE ISSUES. A SURGICAL PROCEDURE WAS PERFORMED TO REMOVE THE IPP. NO COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25398477 ↗
• InjuryMay 6, 2026Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) WAS TOO LARGE. A SURGICAL PROCEDURE WAS PERFORMED DURING WHICH THE DEVICE WAS EXPLANTED AND REPLACED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25099588 ↗
• InjuryApr 22, 2026Fluid/Blood Leak; Mechanical Problem

  IT WAS REPORTED THAT THE INFLATABLE PENILE PROSTHESIS (IPP) DID NOT WORK PROPERLY. UPON INSPECTION, FLUID LOSS WAS NOTICED. AS A RESULT, THE DEVICE WAS EXPLANTED AND REPLACED. THE RESERVOIR WAS LEFT BEHIND. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24957420 ↗
• InjuryApr 1, 2026Collapse; Fluid/Blood Leak; Inflation Problem; Material Puncture/Hole

  IT WAS REPORTED THAT A PATIENT WITH AN INFLATABLE PENILE PROSTHESIS (IPP) IMPLANT DEVICE HAS REPORTED THAT THE DEVICE HAS FAILED. PER THE PATIENT, THE DEVICE WOULD TYPICALLY TAKE 20 PRESSES FOR FULL INFLATION BUT SLOWLY OVER THE PAST TWO MONTHS THAT STARTED TO DECREASE TO 15 THEN 10 AND NOW TO NOTHING, AND THE PUMP WAS COLLAPSED WITH NO INFLATION. A SURGICAL PROCEDURE WAS PERFORMED DURING WHICH THE DEVICE WAS EXPLANTED. UPON EXPLANT, THE PHYSICIAN IDENTIFIED A HOLE ON BOTH CYLINDERS AND FLUID LOSS. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24756774 ↗
• InjuryMar 31, 2026Fluid/Blood Leak; Inflation Problem; Material Puncture/Hole; Migration; Failure to Deflate

  IT WAS REPORTED THAT THE PATIENT WITH THIS INFLATABLE PENILE PROSTHESIS (IPP) PRESENTED WITH INABILITY TO INFLATE THE DEVICE, PAIN LOCALIZED IN THE SCROTUM, AND DIFFICULTY IDENTIFYING THE DEFLATE BUTTON. THE PATIENT ALSO NOTED AN INDENTATION ON THE PUMP BULB AND DESCRIBED SHARP, NEEDLE LIKE PAIN ISOLATED TO THE LEFT SIDE OF THE SCROTUM. THERE IS NO ADDITIONAL INFORMATION REPORTED.

  Patient problems: Deformity/ Disfigurement; Pain

  MAUDE report 24749915 ↗
• InjuryMar 30, 2026Unintended Deflation

  IT WAS REPORTED THAT THE PATIENT'S INFLATABLE PENILE PROSTHESIS (IPP) EXHIBITED SPONTANEOUS DEFLATION ISSUES. THE PATIENT NOTING THAT THE DEVICE WOULD LOSE RIGIDITY WITHIN 10 TO 15 MINUTES. DURING THE SUBSEQUENT SURGICAL PROCEDURE, THE PHYSICIAN CONFIRMED THAT THE DEVICE WAS ABLE TO CYCLE; THEREFORE, ONLY THE PUMP WAS REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24717628 ↗
• InjuryFeb 23, 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 AND REPLACED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24422574 ↗
• InjuryFeb 23, 2026Inflation Problem; Mechanical Problem

  IT WAS REPORTED THAT THE INFLATABLE PENILE PROSTHESIS (IPP) PUMP WAS DIFFICULT FOR THE PATIENT TO OPERATE AND EXHIBITED DELAYED FILLING. AS A RESULT, THE ENTIRE DEVICE WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24416507 ↗
• InjuryFeb 11, 2026Collapse; Fluid/Blood Leak; Inflation Problem; Nonstandard Device; Material Puncture/Hole

  IT WAS REPORTED THAT THE PATIENT'S INFLATABLE PENILE PROSTHESIS (IPP) EXHIBITED INFLATION ISSUES, ACHIEVING ONLY APPROXIMATELY 80% INFLATION. ADDITIONALLY, AFTER 8-10 PUMPS, THE PUMP REPORTEDLY REMAINED FLAT. DURING A SUBSEQUENT SURGICAL PROCEDURE, FLUID LOSS WAS IDENTIFIED WHEN THE RESERVOIR WAS EMPTIED AND ONLY APPROXIMATELY 30 CC COULD BE RECOVERED. FURTHER INSPECTION DETERMINED BOTH THE SOURCE AND THE LOCATION OF THE FLUID LOSS, IDENTIFYING A HOLE IN BOTH CYLINDERS AT THE JUNCTION WHERE THE TUBING CONNECTS TO THE CYLINDERS. THE IPP WAS REPLACED, AND NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24313007 ↗
• InjuryFeb 9, 2026Fluid/Blood Leak; Inflation Problem

  IT WAS REPORTED THAT A PATIENT WITH AN INFLATABLE PENILE PROSTHESIS (IPP) PRESENTED WITH AN INABILITY TO INFLATE THE DEVICE. A REVISION SURGERY WAS PERFORMED, DURING WHICH THE PHYSICIAN SUSPECTED FLUID LOSS IN THE SYSTEM. THE DEVICE WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24299743 ↗
• InjuryFeb 4, 2026Fluid/Blood Leak; Mechanical Problem; Connection Problem

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) PRESENTED A MECHANICAL PROBLEM DUE TO A FLUID LOSS, AND UPON EXPLANT IT WAS FOUND THAT THE CONNECTION HAD COME APART. THE IPP WAS EXPLANTED, WASHED OUT WITH ANTIBIOTIC IRRIGATION, REMEASURED AND A NEW PROSTHESIS WAS IMPLANTED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24260760 ↗
• MalfunctionJan 30, 2026Deflation Problem; Mechanical Problem; Nonstandard Device

  IT WAS REPORTED THAT DURING DEVICE PREPARATION PRIOR TO IMPLANTATION, THE INFLATABLE PENILE PROSTHESIS (IPP) PRESENTED A MECHANICAL PROBLEM. THE CYLINDERS INFLATED PROPERLY BUT FAILED TO DEFLATE WHEN THE DEFLATION BUTTON WAS PRESSED. MANUAL ATTEMPTS TO DEFLATE THE CYLINDERS WERE UNSUCCESSFUL. AN ALTERNATE DEVICE WAS USED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24223408 ↗
• InjuryJan 7, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WITH THIS INFLATABLE PENILE PROSTHESIS (IPP) EXPERIENCED PAIN LOCALIZED TO THE PUMP AREA. A SURGICAL PROCEDURE WAS PERFORMED IN WHICH THE INFLATABLE DEVICE WAS REMOVED AND REPLACED WITH A MALLEABLE IMPLANT. THERE WERE NO FURTHER PATIENT COMPLICATIONS REPORTED.

  Patient problems: Pain

  MAUDE report 23995899 ↗
• InjuryJan 5, 2026Fluid/Blood Leak; Inflation Problem; Nonstandard Device; Material Puncture/Hole

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) PRESENTED AN INFLATION PROBLEM, IT WAS REPORTED THAT THE PUMP WAS NOT WORKING DUE TO A FLUID LOSS FROM TWO SMALL HOLES IN TUBING. THE IPP WAS EXPLANTED AND REPLACED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23956999 ↗
• InjuryDec 30, 2025Collapse; Fluid/Blood Leak; Inflation Problem; Collapse; Fluid/Blood Leak; Inflation Problem

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) EXHIBITED LOSS OF RIGIDITY, AND THE PUMP REMAINED FLAT, SUGGESTING POSSIBLE FLUID LOSS. A SURGICAL PROCEDURE WAS PERFORMED, DURING WHICH THE RESERVOIR WAS IDENTIFIED TO BE EMPTY. THE SOURCE OF THE FLUID LOSS COULD NOT BE IDENTIFIED; HOWEVER, THE PHYSICIAN SUSPECTED IT MAY HAVE ORIGINATED FROM A TUBING CONNECTION. ALL DEVICE COMPONENTS WERE REMOVED AND REPLACED. NO PATIENT SIGNS OR SYMPTOMS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23924450 ↗
• InjuryNov 27, 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) EXPERIENCED ACHENESS FEVER AND INFECTION. AS A RESULT, THE DEVICE WAS EXPLANTED AND REPLACED WITH TACTRA. NO FURTHER PATIENT COMPLICATIONS REPORTED.

  Patient problems: Fever; Pain; Unspecified Infection

  MAUDE report 23667627 ↗
• InjuryNov 14, 2025Fluid/Blood Leak; Inflation Problem; Fluid/Blood Leak; Inflation Problem

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) WAS UNABLE TO INFLATE DUE TO FLUID LOSS. THE IPP WAS EXPLANTED AND REPLACED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23553208 ↗
• InjuryNov 10, 2025Inflation Problem; Inadequacy of Device Shape and/or Size; Migration; Inflation Problem; Inadequacy of Device Shape and/or Size; Migration

  IT WAS REPORTED THAT THE PUMP OF THIS INFLATABLE PENILE PROSTHESIS (IPP) HAD MIGRATED FROM THE RIGHT SIDE OF THE SCROTUM TO BEHIND ONE OF THE TESTICLES, MAKING CYLINDER INFLATION DIFFICULT. ADDITIONALLY, THE CYLINDERS WERE TOO SHORT AND NEEDED TO BE RESIZED. A SURGICAL PROCEDURE WAS PERFORMED TO REMOVE AND REPLACE THE CYLINDERS, PUMP, AND REAR TIPS. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23512012 ↗
• InjuryNov 3, 2025Fluid/Blood Leak; Mechanical Problem; Fluid/Blood Leak; Mechanical Problem

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) WAS NOT WORKING PROPERLY. DURING SURGERY, FLUID LOSS WITHIN THE SYSTEM WAS OBSERVED. AS A RESULT, THE DEVICE WAS EXPLANTED AND REPLACED. NO ADDITIONAL INFORMATION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23453102 ↗