AMS 700 CX MS Pump 72404233Recalls & reported problems

Summary

The FDA's MAUDE database contains 342 adverse event reports that list this exact device (DI 00878953003467), received between Jul 5, 2018 and Sep 28, 2026 — classified as 307 injuries, 35 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (144 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 342 reports, in the reporter's own words as published by the FDA.

• InjurySep 28, 2026Inflation Problem; Material Puncture/Hole; Air/Gas in Device

  It was reported that this Inflatable Penile Prosthesis (IPP) presented inflation issues. Upon revision, physician observed that tubing was fractured on the right cylinder at the junction of tubing and the pump. Additional information received states that air was present in the pump. A surgical procedure was performed during which the existing device was explanted and replaced. There were no patient complications reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50915104 ↗
• InjurySep 10, 2026Fluid/Blood Leak; Inflation Problem; Mechanical Problem; Air/Gas in Device

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50722321 ↗
• InjuryAug 19, 2026Fluid/Blood Leak; Mechanical Problem; Material Puncture/Hole

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50331324 ↗
• InjuryJul 8, 2026Fluid/Blood Leak; Mechanical Problem

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) WAS NOT CYCLING. A SURGICAL PROCEDURE WAS PERFORMED DURING WHICH THE DEVICE WAS EXPLANTED. UPON EXPLANT THE PHYSICIAN IDENTIFIED A FLUID LEAK ON THE RIGHT CYLINDER. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25751082 ↗
• MalfunctionMay 26, 2026Degraded; Mechanical Problem

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) IMPLANT DEVICE HAD A BULGE DURING IMPLANTATION. THE STRUCTURAL LAYERS OF THE PROSTHETIC CYLINDERS WERE FOUND TO BE DISSOCIATED FROM ONE ANOTHER WHICH RENDERED THE DEVICE AS NON-FUNCTIONAL. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY USING A REPLACEMENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25286258 ↗
• InjuryMay 20, 2026Fluid/Blood Leak; Mechanical Problem

  IT WAS REPORTED THAT THE PATIENT'S INFLATABLE PENILE PROSTHESIS (IPP) WAS NOT FUNCTIONING PROPERLY. A SURGICAL PROCEDURE WAS PERFORMED DURING WHICH A LEAK WAS IDENTIFIED IN THE LEFT CYLINDER, RESULTING IN THE DEVICE NOT CYCLING PROPERLY. THE IPP WAS REMOVED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25232685 ↗
• InjuryMay 20, 2026Mechanical Problem

  It was reported that this Inflatable Penile Prosthesis (IPP) pump was experiencing issues. A surgical procedure was performed in which the device was explanted. No patient complications were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25231144 ↗
• MalfunctionMay 14, 2026Deflation Problem; Fluid/Blood Leak; Inflation Problem; Mechanical Problem

  IT WAS REPORTED THAT THE PATIENT'S INFLATABLE PENILE PROSTHESIS (IPP) IS NOT FUNCTIONING PROPERLY, EXHIBITED INFLATION AND DEFLATION ISSUES, AND A DEVICE FLUID LOSS. THE DEVICE IS OUT OF SERVICE BUT REMAINS IMPLANTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25174336 ↗
• InjuryMar 31, 2026Fluid/Blood Leak; Mechanical Problem; Material Puncture/Hole

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) WAS NOT WORKING. UPON INSPECTION, A HOLE IN TUBING LEADING TO THE RESERVOIR AND RELATED FLUID LOSS WERE 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 24743185 ↗
• InjuryMar 24, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WITH AN INFLATABLE PENILE PROSTHESIS (IPP) EXPERIENCED PENILE EROSION ON THE RIGHT SIDE AND INFECTION IN THE PENIS. A SURGICAL PROCEDURE WAS PERFORMED TO REMOVE THE IPP AND REPLACED IT WITH A MALLEABLE DEVICE ON THE LEFT SIDE. THE INFECTION WAS TREATED WITH ANTIBIOTICS. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Erosion; Unspecified Infection

  MAUDE report 24675061 ↗
• InjuryMar 17, 2026Fluid/Blood Leak; Mechanical Problem; Material Puncture/Hole

  IT WAS REPORTED THAT A PATIENT WITH AN INFLATABLE PENILE PROSTHESIS (IPP) PRESENTED WITH A NONFUNCTIONING DEVICE. A REVISION SURGERY WAS PERFORMED, DURING WHICH THE PHYSICIAN CONFIRMED FLUID LOSS DUE TO A HOLE IN THE CYLINDER. THE RIGHT SIDE CYLINDER SHOWED EXTENSIVE SURFACE SCARRING INVOLVING THE DACRON FIBER. THE DEVICE WAS EXPLANTED AND REPLACED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24619268 ↗
• InjuryMar 5, 2026Inflation Problem; Mechanical Problem; Nonstandard Device; Material Puncture/Hole; Migration

  IT WAS REPORTED THAT THE PATIENT WITH THIS INFLATABLE PENILE PROSTHESIS (IPP) WAS UNABLE TO PUMP THE DEVICE, AND THE CYLINDERS WERE NOT FILLING PROPERLY. UPON INSPECTION, A TEAR WAS IDENTIFIED IN THE PROXIMAL END OF THE LEFT CYLINDER. THE PHYSICIAN WAS UNSURE IF THE PERFORATION WAS PRESENT BEFORE THE SURGERY OR IF IT OCCURRED WHILE ATTEMPTING TO REMOVE IT. ADDITIONALLY, THE OUTER SILICONE LAYER OF THE LEFT CYLINDER WAS FOUND TO BE DETACHED AND HAD MIGRATED TOWARD THE DISTAL END. AS A RESULT, THE DEVICE WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24521924 ↗
• InjuryMar 2, 2026Inflation Problem; Mechanical Problem; Nonstandard Device

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) PRESENTED A MECHANICAL PROBLEM. ON EXAMINATION, THE CYLINDERS DID NOT FILL AND REMAINED FLACCID. THE SLEEVE COLLAPSED AFTER THE SECOND PUMP, PRODUCING A SENSATION OF AIR IN THE SYSTEM, WHICH SUGGESTED A FLUID LEAK. REPLACEMENT SURGERY HAS BEEN SCHEDULE. THERE IS NO ADDITIONAL INFORMATION REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24482124 ↗
• InjuryFeb 24, 2026Collapse; Fluid/Blood Leak; Inflation Problem; Material Puncture/Hole; Air/Gas in Device

  IT WAS REPORTED THAT THE PATIENT WITH THIS INFLATABLE PENILE PROSTHESIS (IPP) WAS UNABLE TO INFLATE HIS DEVICE. UPON INSPECTION, A HOLE WAS IDENTIFIED IN ONE OF THE CYLINDERS ALONG WITH ASSOCIATED FLUID LOSS. ADDITIONALLY, THE PUMP REMAINED FLAT, AND THE PRESENCE OF AIR WAS 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 24434628 ↗
• InjuryFeb 6, 2026Collapse; Fluid/Blood Leak; Inflation Problem; Material Puncture/Hole; Air/Gas in Device

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) WAS NO LONGER INFLATING AND THE PUMP REMAINED FLAT. UPON INSPECTION, A HOLE WAS IDENTIFIED IN THE LEFT CYLINDER AT THE PROXIMAL END NEAR THE JUNCTION WHERE THE TUBING ATTACHES, ALONG WITH EVIDENCE OF FLUID LOSS AND AIR IN THE SYSTEM. AS A RESULT, THE CYLINDERS AND PUMP WERE EXPLANTED AND REPLACED. THE RESERVOIR WAS LEFT IN PLACE AND REFILLED WITH NEW SALINE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24280567 ↗
• InjuryFeb 4, 2026Mechanical Problem; Migration

  IT WAS REPORTED THAT THE PATIENT IMPLANTED WITH THIS INFLATABLE PENILE PROSTHESIS (IPP) ENCOUNTERED FUNCTIONAL PROBLEMS AND PART OF THE LEFT CYLINDER HAD HERNIATED OUT OF POSITION. A SURGICAL PROCEDURE WAS PERFORMED WHEREIN THE PHYSICIAN REMOVED AND REPLACED THE ENTIRE DEVICE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 24264697 ↗
• InjuryJan 30, 2026Deflation Problem; Inflation Problem; Mechanical Problem

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) WAS NOT INFLATING OR DEFLATING, AND THE PUMP WAS NOT OPERATING NORMALLY. TROUBLESHOOTING IDENTIFIED THAT THE ISSUE WAS IN THE PUMP VALVE COMPONENT. A SURGICAL PROCEDURE WAS PERFORMED IN WHICH THE DEVICE WAS EXPLANTED AND REPLACED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24221089 ↗
• InjuryJan 29, 2026Nonstandard Device; Material Puncture/Hole

  IT WAS REPORTED THAT THE CYLINDER OF THIS INFLATABLE PENILE PROSTHESIS (IPP) WAS RUPTURED. AS A RESULT, THE CYLINDERS AND PUMP WERE EXPLANTED AND REPLACED. NO ADDITIONAL INFORMATION REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24217837 ↗
• InjuryJan 8, 2026Collapse; Fluid/Blood Leak

  IT WAS REPORTED THAT THE PUMP OF THIS INFLATABLE PENILE PROSTHESIS (IPP) STOPPED WORKING AS IT WOULD NOT INFLATE WHEN SQUEEZED, REMAINING FLAT. DURING A SURGICAL PROCEDURE, FLUID LOSS WAS IDENTIFIED; HOWEVER, DESPITE TESTING, THE SOURCE AND LOCATION OF THE LEAK COULD NOT BE DETERMINED. THE IPP WAS REPLACED, AND NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24004877 ↗
• InjuryDec 9, 2025Fluid/Blood Leak; Inflation Problem; Fluid/Blood Leak; Inflation Problem

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) WAS NOT INFLATING AND EXHIBITED 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 23761838 ↗
• InjuryDec 4, 2025Degraded; Mechanical Problem; Degraded; Mechanical Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23722566 ↗
• InjuryDec 4, 2025Fluid/Blood Leak; Inflation Problem; Material Puncture/Hole; Air/Gas in Device; Fluid/Blood Leak; Inflation Problem; Material Puncture/Hole; Air/Gas in Device

  IT WAS REPORTED THAT THE INFLATABLE PENILE PROSTHESIS (IPP) IMPLANT DEVICE WAS NOT INFLATING AND THERE WAS FLUID LOSS ON BOTH CYLINDERS. THERE WAS AIR OBSERVED IN THE DEVICE, THERE WAS A HOLE IN THE LEFT AND RIGHT CYLINDERS WHICH WERE THE SOURCES OF THE FLUID LOSS. THIS WAS IDENTIFIED BY VISUALIZATION. THE PHYSICIAN REMOVED AND REPLACED THE 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 23712971 ↗
• InjuryNov 25, 2025Fluid/Blood Leak; Mechanical Problem; Nonstandard Device; Material Puncture/Hole; Fluid/Blood Leak; Mechanical Problem; Nonstandard Device; Material Puncture/Hole

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) WAS NOT WORKING PROPERLY AND THE PATIENT NOTICED LOSS OF RIGIDITY DURING INFLATION. UPON INSPECTION FLUID LOSS FROM THE CYLINDERS WAS NOTICED POSSIBLY DUE TO MATERIAL FATIGUE OR MICROPERFORATION. AS A RESULT, THE PUMP AND CYLINDERS WERE EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23649528 ↗
• InjuryNov 17, 2025Fluid/Blood Leak; Mechanical Problem; Nonstandard Device; Material Puncture/Hole; Fluid/Blood Leak; Mechanical Problem; Nonstandard Device; Material Puncture/Hole

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) PRESENTED A MECHANICAL PROBLEM, WITH FLUID LOSS REPORTED AT THE PROXIMAL END OF THE CYLINDER DUE TO A PERFORATION. THE IPP WAS EXPLANTED AND REPLACED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23575286 ↗
• InjuryOct 31, 2025Fluid/Blood Leak; Inflation Problem; Material Puncture/Hole; Material Deformation; Air/Gas in Device; Fluid/Blood Leak; Inflation Problem; Material Puncture/Hole; Material Deformation; Air/Gas in Device

  IT WAS REPORTED THAT THE PATIENT'S INFLATABLE PENILE PROSTHESIS (IPP) PRESENTED FLUID LOSS AND INFLATION ISSUES. THE OUTER LAYER OF THE CYLINDERS WAS TORN. A SURGICAL PROCEDURE WAS PERFORMED, DURING WHICH FLUID LOSS WAS CONFIRMED TO BE DUE TO A TEAR IN ONE OF THE CYLINDERS, WHICH HAD A VISIBLE HOLE. ADDITIONALLY, AIR WAS FOUND IN THE PUMP. THE DEVICE WAS EXPLANTED AND REPLACED WITH A NEW IPP. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23436785 ↗