AMS 700 CX MS Pump 72404232Recalls & reported problems

Summary

The FDA's MAUDE database contains 639 adverse event reports that list this exact device (DI 00878953003450), received between Jan 12, 2018 and Sep 22, 2026 — classified as 566 injuries, 73 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (261 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 639 reports, in the reporter's own words as published by the FDA.

• InjurySep 22, 2026Inflation Problem; Material Puncture/Hole

  It was reported that this Inflatable Penile Prothesis (IPP)'s pump wasn't working properly, it stayed flat and would not inflate. Upon revision, a hole in right cylinder was noticed. As a result, the device was explanted and replaced. No further patient complications were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50855055 ↗
• InjurySep 7, 2026Inflation Problem; Material Puncture/Hole

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50651159 ↗
• InjurySep 4, 2026Fluid/Blood Leak; Inflation Problem

  It was reported that the patient's Inflatable Penile Prosthesis (IPP) exhibited inflation issues. During a surgical procedure to remove the device, it was noted that the reservoir was empty. Per the patient's request, the IPP was replaced with a malleable penile prosthesis. No patient complications were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50602234 ↗
• InjurySep 4, 2026Fluid/Blood Leak; Inflation Problem; Air/Gas in Device

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50600710 ↗
• InjurySep 2, 2026Fluid/Blood Leak; Inflation Problem; Material Puncture/Hole; Air/Gas in Device

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50569004 ↗
• InjuryAug 18, 2026Fluid/Blood Leak; Inflation Problem; Material Puncture/Hole

  It was reported that this Inflatable Penile Prosthesis (IPP) was not inflating. A surgical procedure was performed during which the cylinders and pump were explanted and replaced. Upon explant the physician identified broken tubing to the pump and fluid leakage. After connection of the replacement components the IPP functioned properly. No additional information was provided.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50290595 ↗
• InjuryAug 10, 2026Collapse; Inflation Problem; Mechanical Problem; Material Puncture/Hole

  It was reported that a patient stated that this Inflatable Penile Prosthesis (IPP) exhibited a device deficiency. A computed tomography (CT) scan was performed, and the physician determined that the device needed to be replaced. During an evaluation, a possible sticky pump issue was identified, as the pump remained collapsed and the device did not inflate correctly. A surgical procedure was performed, during which a broken pump hose was identified. As a result, the IPP was removed and replaced. No patient complications were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50196780 ↗
• InjuryJun 10, 2026Fluid/Blood Leak; Inflation Problem; Mechanical Problem; Nonstandard Device

  IT WAS REPORTED THAT THE PUMP OF THIS INFLATABLE PENILE PROSTHESIS (IPP) WAS NOT WORKING PROPERLY. UPON ANALYSIS THE BALLOON WAS FOUND EMPTY. AS A RESULT, THE DEVICE WAS EXPLANTED AND REPLACED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25465458 ↗
• InjuryJun 8, 2026Mechanical Problem

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) WAS NOT FUNCTIONING AS WELL. A SURGICAL PROCEDURE WAS PERFORMED DURING WHICH THE ENTIRE DEVICE WAS EXPLANTED AND REPLACED WITH A MALLEABLE PENILE PROSTHESIS DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25437414 ↗
• InjuryJun 3, 2026Fluid/Blood Leak; Nonstandard Device

  IT WAS REPORTED THAT AN INFLATABLE PENILE PROSTHESIS (IPP) EXHIBITED FLUID LOSS. A SURGICAL PROCEDURE WAS PERFORMED TO REMOVE AND REPLACE THE IPP. THE LOCATION AND SOURCE OF THE FLUID LOSS ARE UNCLEAR. NO FARTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25385212 ↗
• InjuryJun 2, 2026Degraded

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) HAD A CYLINDER BULGE. A SURGICAL PROCEDURE WAS PERFORMED IN WHICH THE DEVICE WAS EXPLANTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25368521 ↗
• InjuryJun 2, 2026Inflation Problem; Mechanical Problem

  IT WAS REPORTED THAT A PATIENT WITH AN INFLATABLE PENILE PROSTHESIS (IPP) PRESENTED WITH A NONFUNCTIONING DEVICE WITH INFLATION ISSUES. A REVISION SURGERY WAS PERFORMED IN WHICH PHYSICIAN EXPLANTED THE DEVICE AND REPLACED IT WITH A TACTRA DEVICE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25368128 ↗
• InjuryMay 28, 2026Nonstandard Device; Insufficient Device Problem Information

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) WAS EXPLANTED AND RETURNED WITHOUT INITIAL REPORTER AND ANY PERFORMANCE ALLEGATION INFORMATION. HOWEVER, UPON ANALYSIS OF THE RETURNED COMPONENTS, THE PUMP DID NOT PASS FUNCTIONAL TEST. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25325883 ↗
• InjuryMay 20, 2026Inflation Problem; Mechanical Problem

  IT WAS REPORTED THAT THE PATIENT WITH THIS INFLATABLE PENILE PROSTHESIS (IPP) EXPERIENCED THAT THE ERECTION DID NOT REMAIN STIFF DURING SEXUAL INTERCOURSE, ALTHOUGH THE DEVICE REMAINED RIGID WHEN NOT USED FOR INTERCOURSE. PUMP DIFFICULTY WAS REPORTED; HOWEVER, THE CYLINDERS WERE ABLE TO INFLATE. A SURGICAL PROCEDURE WAS PERFORMED IN WHICH THE PUMP WAS EXPLANTED AND REPLACED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25230328 ↗
• MalfunctionMay 4, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) PRESENTED A FLUID LEAK. THE IPP IS CURRENTLY IMPLANTED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25072144 ↗
• InjuryApr 28, 2026Inflation Problem

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) IMPLANT DEVICE WOULD NOT INFLATE CORRECTLY. A SURGICAL PROCEDURE WAS PERFORMED DURING WHICH THE ENTIRE DEVICE WAS EXPLANTED AND REPLACED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25023671 ↗
• InjuryApr 22, 2026Collapse; Inflation Problem; Material Puncture/Hole; Air/Gas in Device

  IT WAS REPORTED THAT THE PATIENT'S INFLATABLE PENILE PROSTHESIS (IPP) EXHIBITED INFLATION ISSUES. A SURGICAL PROCEDURE WAS PERFORMED, DURING WHICH IT WAS DETERMINED THAT THE LEFT CYLINDER HAD DEVELOPED A HOLE DUE TO WEAR OVER TIME. ADDITIONALLY, AIR WAS OBSERVED WITHIN THE PUMP, WHICH WAS NOTED TO BE COLLAPSED. BOTH CYLINDERS WERE EXPLANTED AND REPLACED, WHILE THE RESERVOIR WAS RETAINED AND REUSED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24956100 ↗
• InjuryApr 14, 2026Unintended Deflation

  IT WAS REPORTED THAT THE PATIENT WITH THIS INFLATABLE PENILE PROSTHESIS (IPP) STATED THAT HIS DEVICE DID NOT STAY INFLATED. AS A RESULT, THE DEVICE WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24874567 ↗
• InjuryApr 14, 2026Fluid/Blood Leak; Mechanical Problem; Nonstandard Device

  IT WAS REPORTED THAT THE PATIENT WITH THIS INFLATABLE PENILE PROSTHESIS (IPP) STATED HE HEARD A POPPING SOUND AND THAT THE DEVICE WAS NOT FUNCTIONING PROPERLY. UPON INSPECTION, FLUID LOSS WAS IDENTIFIED. AS A RESULT, THE DEVICE WAS EXPLANTED AND REPLACED, AND THE RESERVOIR WAS IMPLANTED IN A DIFFERENT LOCATION ON THE LEFT SIDE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24872680 ↗
• InjuryMar 30, 2026Fluid/Blood Leak; Inflation Problem; Material Puncture/Hole

  IT WAS REPORTED THAT THE PATIENT'S INFLATABLE PENILE PROSTHESIS (IPP) EXHIBITED INFLATION PROBLEMS. A SURGICAL PROCEDURE WAS PERFORMED DURING WHICH A FLUID LOSS AND A HOLE DUE TO WEAR WAS IDENTIFIED IN THE RIGHT CYLINDER. THE IPP WAS REMOVED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24736959 ↗
• InjuryMar 30, 2026Inflation Problem; Mechanical Problem

  IT WAS REPORTED THAT THE PATIENT'S INFLATABLE PENILE PROSTHESIS (IPP) WAS NOT FUNCTIONING PROPERLY, AS THE DEVICE WOULD NOT INFLATE. A SURGICAL PROCEDURE WAS PERFORMED DURING WHICH THE IPP WAS REMOVED AND REPLACED. NO NOTABLE FLUID LOSS WAS OBSERVED FROM THE EXPLANTED DEVICE, AND NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24708661 ↗
• MalfunctionMar 25, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) PRESENTED A FLUI LOSS. THE IPP IS CURRENTLY IMPLANTED, AND THE REPLACEMENT SURGERY IS THE NEXT STEP. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24686888 ↗
• InjuryMar 19, 2026Collapse; Fluid/Blood Leak; Inflation Problem; Material Puncture/Hole; Connection Problem; Air/Gas in Device

  IT WAS REPORTED THAT A PATIENT WITH AN INFLATABLE PENILE PROSTHESIS (IPP) PRESENTED WITH A DEVICE THAT WOULD NOT INFLATE. A REVISION SURGERY WAS PERFORMED, DURING WHICH THE PHYSICIAN CONFIRMED FLUID LOSS WITHIN THE SYSTEM DUE TO BROKEN TUBING AT THE CONNECTION NEAR THE LEFT CYLINDER. DURING ATTEMPTED INFLATION, THE PUMP BULB REMAINED FLAT. THE REPORTED CAUSE OF THE ISSUE WAS ATTRIBUTED TO THE TUBING BEING BROKEN OR DISCONNECTED, RESULTING IN SYSTEM FLUID LOSS. IT WAS FURTHER INDICATED THAT AIR WAS OBSERVED WITHIN THE DEVICE. THE PUMP WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24640893 ↗
• MalfunctionMar 9, 2026Deflation Problem

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) PRESENTED DEFLATION ISSUES. A REPLACEMENT SURGERY IS PLANNED; HOWEVER, IS HAS NOT BEEN PERFORMED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24553263 ↗
• InjuryFeb 20, 2026Inflation Problem; Material Puncture/Hole

  IT WAS REPORTED THAT THE PATIENT WITH THIS INFLATABLE PENILE PROSTHESIS (IPP) WAS UNABLE TO CYCLE THE IMPLANT, AS IT WAS NOT INFLATING. DURING SURGICAL EVALUATION, THE RIGHT CYLINDER WAS FOUND TO BE BROKEN. ALL COMPONENTS OF THE DEVICE WERE EXPLANTED AND REPLACED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24403301 ↗