AMS 700 LGX MS Pump 72404253Recalls & reported problems

Summary

The FDA's MAUDE database contains 174 adverse event reports that list this exact device (DI 00878953003610), received between Oct 12, 2018 and Sep 28, 2026 — classified as 152 injuries, 22 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (71 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 174 reports, in the reporter's own words as published by the FDA.

• InjurySep 28, 2026Inflation Problem; Mechanical Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50924225 ↗
• InjurySep 1, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Erosion

  MAUDE report 50553492 ↗
• MalfunctionAug 28, 2026Deflation Problem

  Patient problems: Discomfort; Swelling/ Edema

  MAUDE report 50505761 ↗
• InjuryAug 10, 2026Fluid/Blood Leak; Inflation Problem; Material Puncture/Hole

  It was reported that an Inflatable Penile Prosthesis (IPP) was not inflating properly. All device components were examined, and it was identified that the cylinders had holes in their distal ends, resulting in fluid loss. As a result, the IPP was removed and replaced. No patient complications were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50193186 ↗
• InjuryJul 15, 2026Mechanical Problem

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) LOST FUNCTIONAL EFFICACY AND HAD INADEQUATE PERFORMANCE. DURING A CLINIC OFFICE VISIT NON-INVASIVE TROUBLESHOOTING WAS ATTEMPTED INCLUDING MANUAL MANIPULATION OF THE PUMP WITH NO SUCCESS. A SURGICAL PROCEDURE WAS PERFORMED DURING WHICH THE DEVICE WAS EXPLANTED AND REPLACED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25829198 ↗
• InjuryMay 25, 2026Mechanical Problem

  IT WAS REPORTED THAT THE PATIENT'S INFLATABLE PENILE PROSTHESIS (IPP) EXHIBITED BUCKLING OF THE CYLINDER. A SURGICAL PROCEDURE WAS SUBSEQUENTLY PERFORMED, DURING WHICH THE IPP WAS EXPLANTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25273136 ↗
• InjuryApr 1, 2026Fluid/Blood Leak; Mechanical Problem

  IT WAS REPORTED THAT A PATIENT WITH AN INFLATABLE PENILE PROSTHESIS (IPP) WAS UNABLE TO OPERATE THE PUMP AND ACHIEVE A FULL ERECTION. FLUID LOSS WAS SUSPECTED BUT COULD NOT BE CONFIRMED. A SURGICAL PROCEDURE WAS PERFORMED TO REMOVE THE IPP AND REPLACE IT WITH A TACTRA DEVICE. NO COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24756409 ↗
• InjuryMar 11, 2026Inflation Problem

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) WAS NOT INFLATING AND THE PATIENT EXPERIENCED PAIN. AFTER CLINIC INSPECTION, IT WAS DETERMINED THAT THE PATIENT WOULD NEED A NEW DEVICE. A SURGICAL PROCEDURE WAS PERFORMED TO REMOVE AND REPLACE THE IPP. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Pain

  MAUDE report 24573190 ↗
• InjuryDec 30, 2025Inflation Problem; Mechanical Problem; Nonstandard Device; Inflation Problem; Mechanical Problem; Nonstandard Device

  IT WAS REPORTED THAT THE CYLINDERS OF THIS INFLATABLE PENILE PROSTHESIS (IPP) DID NOT INFLATE. THE PUMP DID NOT WORK PROPERLY, A LACK OF ANY LIQUIDE MOVE TO CYLINDERS WERE NOTICED. AS A RESULT, THE DEVICE WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23927685 ↗
• InjuryNov 25, 2025Fluid/Blood Leak; Inflation Problem; Fluid/Blood Leak; Inflation Problem

  IT WAS REPORTED THAT THE PATIENT WITH AN INFLATABLE PENILE PROSTHESIS (IPP) STATED THE DEVICE WAS NOT WORKING, AS HE COULD NOT INFLATE IT. UPON EXPLANT AND TESTING THE COMPONENTS, A SMALL LEAK WAS FOUND IN THE TUBING NEAR THE PUMP. AS A RESULT, THE IPP WAS REMOVED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23650312 ↗
• InjuryNov 10, 2025Fluid/Blood Leak; Inflation Problem; Nonstandard Device; Fluid/Blood Leak; Inflation Problem; Nonstandard Device

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) WAS NOT INFLATING AND HAD FLUID LOSS. AS A RESULT, THE DEVICE WAS EXPLANTED. NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23511890 ↗
• InjuryNov 7, 2025Fluid/Blood Leak; Inflation Problem; Material Puncture/Hole; Fluid/Blood Leak; Inflation Problem; Material Puncture/Hole

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) COULD NOT BE INFLATED, AND FLUID LOSS WAS OBSERVED. DURING EVALUATION, A HOLE WAS IDENTIFIED IN THE TUBING LEADING TO THE RESERVOIR. THE DEVICE WAS REMOVED AND REPLACED WITH A NEW ONE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23497620 ↗
• InjuryOct 15, 2025Collapse; Fluid/Blood Leak; Inflation Problem; Collapse; Fluid/Blood Leak; Inflation Problem

  IT WAS REPORTED THAT THE PHYSICIAN WAS UNABLE TO INFLATE THE INFLATABLE PENILE PROSTHESIS (IPP) DURING A PATIENT CLINIC VISIT AND SUBSEQUENTLY SCHEDULED THE PATIENT FOR SURGERY. DURING THE PROCEDURE, FLUID LOSS WAS OBSERVED AND THE PUMP STAYED FLAT. AS A RESULT, THE DEVICE WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23306667 ↗
• InjuryAug 28, 2025Fluid/Blood Leak; Inflation Problem; Mechanical Problem; Fluid/Blood Leak; Inflation Problem; Mechanical Problem

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) EXHIBITED A MECHANICAL MALFUNCTION. THE PUMP COULD BE COMPRESSED, BUT THE CYLINDERS FAILED TO INFLATE AS EXPECTED. AFTER THE OPERATION, THE EXPLANTED PROSTHESIS WAS INSPECTED, REVEALING A LEAK AT THE JUNCTION BETWEEN THE DISTAL CYLINDER AND THE CYLINDER TIP. THE IPP WAS EXPLANTED AND REPLACED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22911286 ↗
• InjuryAug 19, 2025Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE CYLINDER OF THIS INFLATABLE PENILE PROSTHESIS (IPP) WAS NOT INFLATING. AS A RESULT, THE DEVICE WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22842252 ↗
• InjuryJul 7, 2025Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole

  IT WAS REPORTED THAT THE PATIENT WITH AN INFLATABLE PENILE PROSTHESIS (IPP) WAS NOT ABLE TO INFLATE THE DEVICE. UPON REVISION, IT WAS FOUND THAT THERE WAS A SMALL HOLE IN THE TUBING COMING OUT OF THE CYLINDER CAUSING A FLUID LOSS; THEREFORE, THE IPP WAS REMOVED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22425232 ↗
• InjuryJun 26, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE INFLATABLE PENILE PROSTHESIS (IPP) WAS IMPLANTED ON (B)(6) 2025. THEN, THE PUMP PRESENTED A FILLING DEFECT. THE DEVICE RETURNED TO BE ANALYZED, INDICATING THERE WAS A SURGICAL PROCEDURE PERFORMED TO EXPLANT THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22342520 ↗
• InjuryJun 19, 2025Deflation Problem; Fluid/Blood Leak; Inflation Problem; Material Puncture/Hole; Deflation Problem; Fluid/Blood Leak; Inflation Problem; Material Puncture/Hole

  IT WAS REPORTED THAT, DURING POST-OPERATIVE RECOVERY OF THIS INFLATABLE PENILE PROSTHESIS (IPP) PROCEDURE, THE DEVICE EXHIBITED IMPROPER INFLATION AND DEFLATION. THE PHYSICIAN OBSERVED SIGNS OF A POTENTIAL LOSS OF FLUID, AS THE SALINE VOLUME IN THE RESERVOIR CONSISTENTLY DECREASED. A WEEK LATER, A REVISION SURGERY WAS PERFORMED, DURING WHICH A LEAK DUE TO A SMALL HOLE AT THE DISTAL TIP OF THE RIGHT CYLINDER WAS IDENTIFIED; THEREFORE, CYLINDERS AND PUMP WERE REMOVED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22292394 ↗
• InjuryJun 19, 2025Deflation Problem; Adverse Event Without Identified Device or Use Problem; Deflation Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WITH THIS INFLATABLE PENILE PROSTHESIS (IPP) EXPERIENCED PAIN AND DISCOMFORT. THE PUMP FAILED TO DEFLATE FLUID FROM CYLINDERS. THE IPP WAS EXPLANTED AND REPLACED WITH A COMPETENCE DEVICE. NO FURTHER PATIENT COMPLICATIONS REPORTED.

  Patient problems: Discomfort; Pain

  MAUDE report 22292178 ↗
• InjuryJun 17, 2025Fluid/Blood Leak; Mechanical Problem; Material Puncture/Hole; Fluid/Blood Leak; Mechanical Problem; Material Puncture/Hole

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) STOPPED WORKING. A SURGICAL PROCEDURE WAS PERFORMED, DURING WHICH FLUID LOSS DUE TO A TEAR IN ONE OF THE CYLINDERS WAS NOTED. ALL COMPONENTS WERE REMOVED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22227529 ↗
• InjuryMay 14, 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 INFECTION. THE IPP WAS EXPLANTED. THERE WERE NO DEVICE ISSUES AND NOT FURTHER PATIENT COMPLICATIONS REPORTED.

  Patient problems: Unspecified Infection

  MAUDE report 22017658 ↗
• InjuryApr 3, 2025Fluid/Blood Leak; Adverse Event Without Identified Device or Use Problem; Fluid/Blood Leak; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS DEVICE PRESENTED A FLUID LEAK. DURING REVISION SURGERY, IT WAS FOUND THAT THE DEVICE HAD A FLUID LOSS. THE DEVICE WAS EXPLANTED AND REPLACED. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21763335 ↗
• InjuryMar 26, 2025Fracture; Adverse Event Without Identified Device or Use Problem; Fracture; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE INFLATABLE PENILE PROSTHESIS (IPP) LEFT CYLINDER RUPTURE PRESENTED A RUPTURE. A SURGICAL PROCEDURE WAS PERFORMED TO REPLACE THE SYSTEM. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21699892 ↗
• InjuryMar 19, 2025Fluid/Blood Leak; Mechanical Problem; Material Puncture/Hole; Fluid/Blood Leak; Mechanical Problem; Material Puncture/Hole

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) STOPPED WORKING. THE DEVICE HAD FLUID LOSS, THE CYLINDERS HAD BREAK. THE IPP WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21649496 ↗
• InjuryMar 13, 2025Fluid/Blood Leak; Malposition of Device; Fluid/Blood Leak; Malposition of Device

  IT WAS REPORTED THAT THE INFLATABLE PENILE PROSTHESIS (IPP) LEFT CYLINDER MISPLACED, IT WAS OUT OF CORPORA. THIS CYLINDER WAS SHREDDED SO THERE WAS A FLUID LOSS. A SURGICAL PROCEDURE WAS PERFORMED TO REPLACE WITH THE LEFT CYLINDER INSIDE THE CORPORA. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21600221 ↗