AMS 700 LGX MS Pump 72404301Recalls & reported problems

Summary

The FDA's MAUDE database contains 54 adverse event reports that list this exact device (DI 00878953005720), received between Oct 12, 2018 and Aug 14, 2026 — classified as 48 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (21 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 54 reports, in the reporter's own words as published by the FDA.

• InjuryAug 14, 2026Collapse; Mechanical Problem

  It was reported that this Inflatable Penile Prosthesis (IPP) was not working properly, the pump could not be pressurized and could not bounce back. As a result, the device was explanted. No patient complications were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50260519 ↗
• InjuryAug 11, 2026Mechanical Problem

  It was reported that an Inflatable Penile Prosthesis (IPP) could not be used as intended because the pump could not be pressurized, resulting in the inability to achieve an erection. A surgical procedure was performed to remove the IPP. No patient complications were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50213565 ↗
• InjuryApr 29, 2026Fluid/Blood Leak; Inflation Problem

  IT WAS REPORTED THAT A PATIENT WITH AN INFLATABLE PENILE PROSTHESIS (IPP) PRESENTED WITH A DEVICE THAT STOPPED INFLATING. A REVISION SURGERY WAS PERFORMED, DURING WHICH THE PHYSICIAN CONFIRMED FLUID LOSS FROM THE CYLINDERS, WITH NO HOLES OR CONNECTION ISSUES IDENTIFIED. THE DEVICE WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25038297 ↗
• InjuryApr 27, 2026Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT A PATIENT WITH AN INFLATABLE PENILE PROSTHESIS (IPP) PRESENTED WITH A DEVICE SIZING ISSUE INVOLVING THE CYLINDER. A REVISION SURGERY WAS PERFORMED DURING WHICH THE DEVICE WAS EXPLANTED AND REPLACED WITH A SMALLER CYLINDER. THERE WERE NO REPORTED PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25002417 ↗
• InjuryMar 31, 2026Material Puncture/Hole

  IT WAS REPORTED THAT THE PATIENT'S INFLATABLE PENILE PROSTHESIS (IPP) EXHIBITED A CYLINDER TUBING HOLE. A SURGICAL PROCEDURE WAS PERFORMED TO REPLACE THE PRECONNECT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24744507 ↗
• InjuryMar 25, 2026Material Puncture/Hole

  IT WAS REPORTED THAT A PATIENT WITH AN INFLATABLE PENILE PROSTHESIS (IPP) UNDERWENT A REVISION SURGERY, DURING WHICH THE PHYSICIAN CONFIRMED A PUNCTURE IN THE CYLINDER. A SCRATCH WAS IDENTIFIED ON THE SIDE OF THE DEVICE DURING THE IMPLANT SURGERY, AND THE PERFORATION WAS REPORTED TO HAVE OCCURRED INTRAOPERATIVELY. THE DEVICE WAS EXPLANTED AND REPLACED. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24688712 ↗
• InjuryMar 24, 2026Mechanical Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24673682 ↗
• InjuryJan 12, 2026Fluid/Blood Leak; Material Puncture/Hole

  IT WAS REPORTED THAT TUBING OF THE RIGHT CYLINDER OF THIS INFLATABLE PENILE PROSTHESIS (IPP) HAD A CRACK CAUSING A 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 24046320 ↗
• InjurySep 12, 2025Fluid/Blood Leak; Material Puncture/Hole; Connection Problem; Fluid/Blood Leak; Material Puncture/Hole; Connection Problem

  IT WAS REPORTED THAT A PATIENT WITH AN INFLATABLE PENILE PROSTHESIS (IPP) PRESENTED WITH A FLUID LEAK IN THE CYLINDER. A REVISION SURGERY WAS PERFORMED IN WHICH PHYSICIAN SUSPECTED FROM A PERFORATION OR A CONNECTION PROBLEM WITH THE DEVICE; THEREFORE, WAS EXPLANTED AND REPLACED. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23041590 ↗
• InjurySep 9, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THE CYLINDER TUBE OF THIS INFLATABLE PENILE PROSTHESIS (IPP) WAS PUNCTURED. CONSEQUENTLY, A SURGICAL INTERVENTION WAS PERFORMED TO EXPLANT AND REPLACE THE CYLINDER TUBE. THE REMAINDER OF THE DEVICE IS STILL IMPLANTED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23012233 ↗
• InjuryJun 9, 2025Deflation Problem; Inflation Problem; Mechanical Problem; Deflation Problem; Inflation Problem; Mechanical Problem

  IT WAS REPORTED THAT THE PATIENT WITH THIS INFLATABLE PENILE PROSTHESIS (IPP) PRESENTED PAIN AND DISCOMFORT, THE PUMP PRESENTED A MECHANICAL PROBLEM, IT WAS REPORTED THAT THE PATIENT HAS DIFFICULTY HANDLING THE PUMP AND WHEN PRESSED THE PUMP DOES NOT UNLOCK OR REFILL. THE IPP IS CURRENTLY IMPLANTED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: Discomfort; Pain

  MAUDE report 22172062 ↗
• InjuryJun 6, 2025Inflation Problem; Mechanical Problem; Adverse Event Without Identified Device or Use Problem; Inflation Problem; Mechanical Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WAS UNABLE TO PRESS THE INFLATABLE PENILE PROSTHESIS PUMP. A REVISION SURGERY WAS PERFORMED, DURING WHICH THE PHYSICIAN CONFIRMED THAT THE DEVICE WAS DIFFICULT TO PUMP, RESULTING IN THE INABILITY TO INFLATE THE DEVICE. THE PUMP WAS REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22159667 ↗
• InjuryMay 27, 2025Collapse; Inflation Problem; Mechanical Problem; Collapse; Inflation Problem; Mechanical Problem

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) WAS NOT FULLY INFLATING, AND THE PUMP WOULD OCCASIONALLY GET STUCK. THE PATIENT UNDERWENT SEVERAL ULTRASOUND EVALUATIONS THAT SHOWED A MECHANICAL PROBLEM WITH THE DEVICE. THE DEVICE IS CURRENTLY IMPLANTED, AND THE EXPLANT SURGERY IS ALREADY BOOKED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22092110 ↗
• InjuryMay 9, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE PUMP OF THIS INFLATABLE PENILE PROSTHESIS (IPP) HAD BECOME SO TIGHT THAT IT WAS IMPOSSIBLE TO SQUEEZE IT. THE PHYSICIAN BELIEVES THAT THE VALVE INSIDE 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 21995989 ↗
• InjuryApr 8, 2025Inflation Problem; Defective Device; Adverse Event Without Identified Device or Use Problem; Inflation Problem; Defective Device; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE INFLATABLE PENILE PROSTHESIS (IPP) PUMP COULD NOT BE PRESSURIZED, RESULTING IN INABILITY TO GET AN ERECTION. A SURGICAL PROCEDURE WAS PERFORMED TO REPLACE THE SYSTEM. THERE WERE NO FURTHER PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21800199 ↗
• MalfunctionDec 3, 2024Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE PUMP OF THIS INFLATABLE PENILE PROSTHESIS (IPP) WAS NOT WORKING PROPERLY. TROUBLESHOOTING WAS ATTEMPTED BY THE PHYSICIAN TO NO AVAIL; THEREFORE, A REPLACEMENT SURGERY WAS SCHEDULED. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20834231 ↗
• InjuryOct 8, 2024Mechanical Problem; Adverse Event Without Identified Device or Use Problem; Mechanical Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) WAS NOT WORKING PROPERLY; THEREFORE, A SURGICAL PROCEDURE WAS PERFORMED TO REMOVE THE DEVICE, AND A FUTURE REVISION SURGERY IS PLANNED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20397411 ↗
• InjuryJul 22, 2024Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE INFLATABLE PENILE PROSTHESIS (IPP) WAS NOT INFLATING PROPERLY. THE IPP WAS REPLACED, AND THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19795272 ↗
• InjuryMay 2, 2024Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH THIS IMPLANT THAT WAS NO LONGER DEFLATING RESULTING IN PAIN. THERE HAS BEEN NO SURGICAL INTERVENTION AT THIS TIME, AND THERE WERE NO ADDITIONAL PATIENT COMPLICATIONS REPORTED.

  Patient problems: Discomfort; Pain

  MAUDE report 19234474 ↗
• InjuryMay 1, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT WITH THIS INFLATABLE PENILE PROSTHESIS (IPP) PRESENTED WITH AN INFECTION A MONTH AFTER THE ORIGINAL IMPLANT. THE IPP WAS EXPLANTED. THERE WERE NO ADDITIONAL PATIENT COMPLICATIONS REPORTED.

  Patient problems: Unspecified Infection

  MAUDE report 19222409 ↗
• InjuryMar 20, 2024Adverse 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 LATERAL CURVATURE ON HIS PENIS. THE SUSPECTED CAUSE WAS SCARRING IN THE CAVERNOUS BODY. A REVISION SURGERY WAS PERFORMED TO EXPLANT THE CYLINDERS, DILATE THE CAVERNOUS BODY, AND REIMPLANT THE CYLINDERS WHICH IMPROVED THE CURVATURE. NO DEVICE ISSUES NOR ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Scar Tissue

  MAUDE report 18944808 ↗
• InjuryDec 19, 2023Deflation Problem; Inflation Problem; Mechanical Problem; Deflation Problem; Inflation Problem; Mechanical Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT SURGICAL INTERVENTION TO REVISE THE INFLATABLE PENILE PROSTHESIS (IPP) DUE TO THE PATIENT HAVING DIFFICULTY WITH THE PUMP BECOMING STUCK AFTER 3 OR 4 TIMES OF PRESSING THE BULB. THE PUMP WOULD BECOME STUCK BEFORE THE CYLINDERS ARE FILLED, AND THE PATIENT WOULD HAVE TO PRESS THE DEFLATION BUTTON TO RETURN THE PUMP TO ITS NORMAL STATE. DURING A PROCEDURE, THE SURGEON ATTEMPTED TO FIX THE PUMP BUT WAS UNSUCCESSFUL. THE DEVICE WAS NOT REMOVED AT THE TIME OF THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18357642 ↗
• InjuryDec 6, 2023Material Puncture/Hole; Adverse Event Without Identified Device or Use Problem; Material Puncture/Hole; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS WAS REMOVED DUE TO A MICRO PUNCTURE. A NEW INFLATABLE PENILE PROSTHESIS WAS IMPLANTED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18279754 ↗
• InjuryNov 22, 2023Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS WAS REMOVED AS IT WOULD NOT INFLATE AS EXPECTED. A NEW INFLATABLE PENILE PROSTHESIS WAS IMPLANTED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18193841 ↗
• InjuryAug 18, 2023Inflation Problem; Mechanical Problem; Adverse Event Without Identified Device or Use Problem; Inflation Problem; Mechanical Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED WITH AN INFLATABLE PENILE PROSTHESIS DEVICE. THE PATIENT HAD HEMATOMA POST PROCEDURE, BUT THE PATIENT WAS RECOVERED ONE MONTH AFTER THE IMPLANT SURGERY. THE PATIENT NOTED TWO MONTHS POST PROCEDURE THAT THE IMPLANTATION LENGTH DID NOT MEET HIS EXPECTATIONS. THE PATIENT FURTHER REPORTED THAT THE DEVICE COULD NOT BE INFLATED NORMALLY. AFTER REPEATED DEBUGGING BY THE PHYSICIAN AND THE MAGNETIC RESONANCE IMAGING, THE PHYSICIAN PRELIMINARILY DETERMINED THAT THE PUMP WAS FAULTY. NO SURGICAL INTERVENTION HAS BEEN PERFORMED AS OF YET FOR THE PUMP ISSUE.

  Patient problems: Hematoma

  MAUDE report 17575364 ↗