AMS 700 LGX MS Pump 72404251Recalls & reported problems

Summary

The FDA's MAUDE database contains 611 adverse event reports that list this exact device (DI 00878953003597), received between Oct 4, 2018 and Sep 29, 2026 — classified as 536 injuries, 75 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (208 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 611 reports, in the reporter's own words as published by the FDA.

• InjurySep 29, 2026Fluid/Blood Leak; Material Puncture/Hole

  It was reported that Inflatable Penile Prosthesis (IPP) wasn't working properly due to fluid floss. Upon revision, a fracture in the tubing from pump to reservoir was noticed. As a result, the device was explanted. No further patient complications were replaced.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50932539 ↗
• InjurySep 21, 2026Inflation Problem; Migration

  Patient problems: Unspecified Tissue Injury

  MAUDE report 50848830 ↗
• InjuryAug 27, 2026Migration

  It was reported that this Inflatable Penile Prosthesis (IPP) presented migration of the pump. A surgical procedure was performed during which the existing MS pump was explanted and replaced with a Tenacio pump. There were no patient complications reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50488015 ↗
• InjuryAug 19, 2026Inflation Problem; Material Puncture/Hole

  It was reported that this patient's Inflatable Penile Prothesis (IPP) cylinders failed to inflate. As a result, the device was explanted and a new IPP was implanted. After the extraction, it was observed that both cylinders showed ruptured. No further patient complications were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50329751 ↗
• InjuryAug 12, 2026Inflation Problem

  It was reported that a patient with an Inflatable Penile Prosthesis (IPP) was unable to inflate or deflate the device. The patient complained that the device was too difficult to pump and did not become rigid enough. However, the physician stated that there was no device deficiency and that the issue was related to the patients willingness to use the device. A surgical procedure was performed to remove the existing IPP and replace with a new IPP with a Tenacio pump. No patient complications were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50225889 ↗
• InjuryAug 5, 2026Inflation Problem

  It was reported that this Inflatable Penile Prosthesis (IPP) was not as hard as it used to be and would not inflate like it used to. Even though the physician believed the device was working 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 50142560 ↗
• InjuryJul 21, 2026Inflation Problem; Mechanical Problem

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) STOPPED FUNCTIONING AND EXHIBITED INFLATION ISSUE. THE REASON FOR THE DEVICE DEFICIENCY IS MOST LIKELY TO BE THE PUMP NOT WORKING, AS AN ULTRASOUND SHOWS THAT THERE WAS SUFFICIENT FLUID IN THE SYSTEM. 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 25896392 ↗
• InjuryJul 15, 2026Deflation Problem

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) WOULD NOT DEFLATE. 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 25829192 ↗
• MalfunctionJul 15, 2026Collapse; Deflation Problem; Inflation Problem

  IT WAS REPORTED THAT DURING A SURGICAL IMPLANTATION PROCEDURE OF AN INFLATABLE PENILE PROSTHESIS (IPP), AN ISSUE WAS IDENTIFIED DURING DEVICE PREPARATION. THE DEVICE DID NOT INFLATE PROPERLY AND EXHIBITED A SIGNIFICANT DELAY IN RECOIL. THE DEVICE WAS EVENTUALLY PREPARED; HOWEVER, ADDITIONAL ISSUES WERE NOTED INTRAOPERATIVELY. AFTER INSERTION AND TEST INFLATION, THE DEVICE DID NOT DEFLATE. THE EXPECTED DEFLATION "BUZZ" WAS NOT OBSERVED AND CONTINUED TO DEMONSTRATE VERY SLOW RECOIL DURING INFLATION. THE DEVICE WAS CYCLED APPROXIMATELY TEN TIMES WITH NO IMPROVEMENT, AND MULTIPLE TROUBLESHOOTING TECHNIQUES WERE ATTEMPTED, INCLUDING SQUEEZING THE PUMP BLOCK; HOWEVER, THE ISSUE PERSISTED. AS A RESULT, THE DEVICE WAS NOT USED TO COMPLETE THE PROCEDURE. AN ALTERNATIVE DEVICE WAS USED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25829171 ↗
• InjuryJun 30, 2026Inadequacy of Device Shape and/or Size; Malposition of Device

  IT WAS REPORTED THAT A PATIENT WITH AN INFLATABLE PENILE PROSTHESIS (IPP) PRESENTED WITH THE PUMP RIDING HIGH. A REVISION SURGERY WAS PERFORMED, DURING WHICH THE PHYSICIAN CONFIRMED THE PUMP WAS POSITIONED CLOSE TO THE SHAFT WITH INSUFFICIENT TUBING. THE DEVICE WAS EXPLANTED AND REPLACED, AND A NEW PUMP WAS POSITIONED APPROPRIATELY WITHIN THE SCROTUM. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25673425 ↗
• InjuryJun 19, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) HAD FLUID LOSS. AS A RESULT, THE DEVICE WAS EXPLANTED AND REPLACED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25563818 ↗
• InjuryJun 9, 2026Fluid/Blood Leak; Material Puncture/Hole

  IT WAS REPORTED THAT DURING IMPLANTATION OF THE CYLINDERS OF THIS INFLATABLE PENILE PROSTHESIS (IPP), FOLLOWING CLOSURE OF THE CORPORA CAVERNOSA, THE PHYSICIAN OBSERVED LEAKAGE FROM THE LEFT CYLINDER. UPON INSPECTION, A SMALL HOLE WAS IDENTIFIED IN THE LEFT CYLINDER. THE AFFECTED DEVICE WAS REMOVED, A NEW DEVICE WAS PREPARED, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25446914 ↗
• InjuryJun 5, 2026Inflation Problem; Material Puncture/Hole

  IT WAS REPORTED THAT AN INFLATABLE PENILE PROSTHESIS (IPP) WAS NOT INFLATING. A SURGICAL PROCEDURE WAS PERFORMED, DURING WHICH A BREAK IN THE TUBING WAS IDENTIFIED; AS A RESULT, THE DEVICE WAS REMOVED AND REPLACED. THE PHYSICIAN BELIEVED THAT THE BREAK IN THE TUBING WAS THE CAUSE OF THE INFLATION ISSUE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25416045 ↗
• InjuryApr 24, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WITH AN INFLATABLE PENILE PROSTHESIS (IPP) PRESENTED WITH AN INFECTION. A REVISION SURGERY WAS PERFORMED, DURING WHICH THE PHYSICIAN EXPLANTED THE DEVICE. THERE WERE NO FURTHER PATIENT COMPLICATIONS.

  Patient problems: Unspecified Infection

  MAUDE report 24986221 ↗
• InjuryApr 24, 2026Fluid/Blood Leak; Inflation Problem; Mechanical Problem; Material Puncture/Hole

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) PRESENTED A MECHANICAL PROBLEM, IT WAS REPORTED THAT THE DEVICE PRESENTED AN INFLATION PROBLEM CAUSED BY FLUID LOSS THROUGH A HOLE IN THE TUBING NEAR THE PUMP. THE IPP WAS EXPLANTED AND REPLACED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24982975 ↗
• InjuryApr 22, 2026Mechanical Problem

  IT WAS REPORTED THAT THE PATIENT'S INFLATABLE PENILE PROSTHESIS (IPP) PUMP WAS NOT FUNCTIONING PROPERLY. AS A RESULT, A SURGICAL PROCEDURE WAS PERFORMED, DURING WHICH THE IPP WAS EXPLANTED EXCEPT FOR THE RESERVOIR. A NEW IPP WAS IMPLANTED AND OLD RESERVOIR WAS RETAINED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24955492 ↗
• InjuryApr 17, 2026Inflation Problem

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) IMPLANT DEVICE WAS NOT INFLATING FULLY. A SURGICAL PROCEDURE WAS PERFORMED DURING WHICH THE DEVICE WAS EXPLANTED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24918033 ↗
• InjuryApr 6, 2026Fluid/Blood Leak; Mechanical Problem; Material Puncture/Hole

  IT WAS REPORTED THAT THE PATIENT WITH THIS INFLATABLE PENILE PROSTHESIS (IPP) PRESENTED WITH FRACTURED TUBING AND CYLINDER FELL INSIDE THE SCROTUM, THE DEVICE PRESENTED A MECHANICAL PROBLEM AND A FLUID LOSS. THE IPP WAS EXPLANTED AND REPLACED. THERE IS NO ADDITIONAL INFORMATION REPORTED.

  Patient problems: Perforation

  MAUDE report 24791731 ↗
• InjuryApr 1, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS PATIENT WITH AN INFLATABLE PENILE PROSTHESIS (IPP) IMPLANT DEVICE EXPERIENCED EXTRUSION OF THEIR PUMP COMPONENT AND INFECTION IN THE SCROTUM 2 WEEKS AFTER THEIR IMPLANT SURGERY. A SURGICAL PROCEDURE WAS PERFORMED DURING WHICH THE ENTIRE DEVICE WAS EXPLANTED. THERE WERE NO FURTHER PATIENT COMPLICATIONS REPORTED.

  Patient problems: Erosion; Unspecified Infection

  MAUDE report 24759982 ↗
• InjuryMar 31, 2026Degraded; Inflation Problem

  IT WAS REPORTED THAT THE PATIENT'S INFLATABLE PENILE PROSTHESIS (IPP) EXHIBITED INFLATION ISSUES. DURING A SURGICAL PROCEDURE, AN ANEURYSM IN THE RIGHT CYLINDER WAS IDENTIFIED. THE CYLINDERS AND PUMP WERE REMOVED, WHILE THE RESERVOIR WAS RETAINED. A NEW IPP WAS IMPLANTED, AND NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24745166 ↗
• InjuryMar 25, 2026Malposition of Device

  IT WAS REPORTED THAT THE PUMP OF THIS INFLATABLE PENILE PROSTHESIS (IPP) WAS RIDING HIGH, AND TOO CLOSE TO THE TESTICLES. A SURGICAL PROCEDURE WAS PERFORMED, DURING WHICH THE PUMP WAS REMOVED, AND A NEW ONE WAS PLACED LOWER IN HIS SCROTUM. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24691940 ↗
• InjuryMar 25, 2026Malposition of Device

  IT WAS REPORTED THAT A PATIENT WITH AN INFLATABLE PENILE PROSTHESIS (IPP) PRESENTED WITH A DEVICE THAT WAS NOT POSITIONED CORRECTLY. A REVISION SURGERY WAS PERFORMED, DURING WHICH A SUPERSONIC TRANSPORT DEFORMITY AT THE GLANS WAS CONFIRMED, AND IT WAS STATED THAT THE MISPOSITIONING WAS PRESENT IMMEDIATELY FOLLOWING THE INITIAL PROCEDURE AND DID NOT APPEAR TO BE RELATED TO MIGRATION. UPON REMEASUREMENT, CORPORAL MEASUREMENTS WERE REPORTED TO BE UNCHANGED, AND IT WAS BELIEVED THAT THE MISPOSITIONING WAS MOST LIKELY ASSOCIATED WITH DILATION ISSUES DURING THE INITIAL PROCEDURE RATHER THAN A DEVICE SIZING OR MIGRATION ISSUE. THE DEVICE WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 24690047 ↗
• InjuryMar 25, 2026Collapse; Inflation Problem; Material Puncture/Hole

  IT WAS REPORTED THAT A PATIENT WITH AN INFLATABLE PENILE PROSTHESIS (IPP) PRESENTED WITH A DEVICE THAT WAS UNABLE TO INFLATE AND THE PUMP WAS NOT REFILLING AFTER SQUEEZING IT. A REVISION SURGERY WAS PERFORMED, DURING WHICH THE PHYSICIAN CONFIRMED UPON EXPLANTATION THAT THE RIGHT CYLINDER OUTER SILICONE LAYER HAD RUPTURED. THE DEVICE WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24690044 ↗
• InjuryMar 18, 2026Mechanical Problem; Material Puncture/Hole

  IT WAS REPORTED THAT THE PUMP OF THIS INFLATABLE PENILE PROSTHESIS (IPP) PRESENTED A MECHANICAL PROBLEM. THERE WAS SUSPECTED TEAR IN THE DEVICE. IPP WAS EXPLANTED AND REPLACED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24631771 ↗
• InjuryMar 17, 2026Nonstandard Device; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INFLATABLE PENILE PROSTHESIS (IPP) SURGERY DUE TO UNSPECIFIED REASONS; HOWEVER, UPON ANALYSIS OF THE RETURNED COMPONENTS, MULTIPLE DEVICE ISSUES WERE IDENTIFIED. NO ADDITIONAL INFORMATION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24618804 ↗