AMS 700 CXR MS Pump 72404264Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00878953003726), received between Oct 12, 2018 and Jul 30, 2026 — classified as 11 injuries.

The most frequently reported specific device problem is “Migration” (3 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryJul 30, 2026Human-Device Interface Problem

  It was reported that the patient implanted with an Inflatable Penile Prosthesis (IPP) experienced scrotal pain when operating the Momentary Squeeze (MS) pump. A surgical procedure was performed, during which no device issue was identified. Although the pump continued to inflate the IPP as intended, its use caused significant pain to the patient. The physician noted difficulty when manipulating the MS pump and elected to replace it with a Tenacio pump. The new pump was implanted in a different scrotal pocket. In addition, a capsule believed to be contributing to the patient's pain was excised. No additional patient complications were reported.

  Patient problems: Capsular Contracture; Pain

  MAUDE report 50087091 ↗
• InjuryJul 14, 2026Nonstandard Device

  THIS PRODUCT WAS RETURNED TO THE MANUFACTURER WITHOUT ANY REPORT OF PERFORMANCE ISSUES OR ADVERSE PATIENT EFFECTS. THE RETURNED DEVICE WAS ANALYZED AND A NON-CONFORMANCE WAS IDENTIFIED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25820434 ↗
• InjuryJan 7, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WITH AN INFLATABLE PENILE PROSTHESIS (IPP) EXPERIENCED CYLINDER PROTRUSION AGAINST THE SKIN WITH IMPENDING EROSION; THEREFORE, A SURGICAL PROCEDURE WAS PERFORMED TO REMOVE AND REPLACE THE CYLINDERS, PUMP, AND REAR-TIP EXTENDERS. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Erosion; Unspecified Tissue Injury

  MAUDE report 23989545 ↗
• InjuryOct 23, 2025Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) PRESENTED DEFLATION ISSUES AFTER KEEPING INFLATED FOR AN EXTENDED PERIOD. 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 23376254 ↗
• InjuryMar 31, 2025Migration; Migration

  IT WAS REPORTED THAT THE PATIENT WITH THIS INFLATABLE PENILE PROSTHESIS (IPP) EXPERIENCE ERECTILE DYSFUNCTION. IT WAS NOTICED THAT THE DEVICE HAD PROXIMAL CROSSOVER. THERE WERE NO DEVICE ISSUES. THE PUMP AND CYLINDER WERE EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS REPORTED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 21730226 ↗
• InjurySep 20, 2024Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT THE PATIENT HAD A SURGICAL PROCEDURE TO REVISE AND REPLACE AN INFLATABLE PENILE PROSTHESIS (IPP) DUE TO PATIENT DISSATISFACTION. THE PATIENT FELT THAT THE CURRENT IPP WAS TOO NARROW AND WANTED TO UPSIZE THE DEVICE TO LARGER CYLINDERS. THE PATIENT IS EXPECTED TO FULLY RECOVER FOLLOWING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20268526 ↗
• InjuryNov 29, 2023Migration; Migration

  IT WAS REPORTED THAT THE PATIENT UNDERWENT SURGICAL INTERVENTION TO EXPLANT THE INFLATABLE PENILE PROSTHESIS (IPP) DUE TO THE PUMP ERODING THROUGH THE SCROTUM. THERE WERE NO ADDITIONAL PATIENT COMPLICATIONS REPORTED.

  Patient problems: Erosion

  MAUDE report 18229572 ↗
• InjuryOct 23, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INFLATABLE PENILE PROSTHESIS (IPP) REPLACEMENT SURGERY DUE TO INFECTION. ALL COMPONENTS WERE REMOVED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Unspecified Infection

  MAUDE report 17993230 ↗
• InjuryMar 8, 2023Difficult or Delayed Activation; Adverse Event Without Identified Device or Use Problem; Difficult or Delayed Activation; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN AROUND THE SCROTUM WHEN PUMPING HIS INFLATABLE PENILE PROSTHESIS (IPP) PUMP MULTIPLE TIMES. THE PUMP EXHIBITED ACTIVATION ISSUES. THE PATIENT UNDERWENT A REVISION SURGERY TO REPOSITION THE PUMP. THERE WERE NO FURTHER PATIENT COMPLICATIONS.

  Patient problems: Pain

  MAUDE report 16506858 ↗
• InjuryNov 1, 2021Fluid/Blood Leak; Material Puncture/Hole; Adverse Event Without Identified Device or Use Problem; Migration; Fluid/Blood Leak; Material Puncture/Hole; Adverse Event Without Identified Device or Use Problem; Migration

  IT WAS REPORTED THAT THE PATIENT THE PATIENT HAD THE INFLATABLE PENILE PROSTHESIS PUMP AND CYLINDERS REMOVED AS THE CYLINDER HERNIATED OUT OF THE LEFT CORPORA. THE CYLINDERS RUBBED AGAINST EACH OTHER AND FORMED A SMALL HOLE THAT LED TO A FLUID LEAK. NEW INFLATABLE PENILE PROSTHESIS PUMP AND CYLINDERS COMPONENTS WERE IMPLANTED. THE PATIENT WAS EXPECTED TO FULLY RECOVER.

  Patient problems: Erosion

  MAUDE report 12729704 ↗
• InjuryOct 12, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT HAD AN INFLATABLE PENILE PROSTHESIS EXPLANTED AND REPLACED WITH A 18CM X 9.5 MM IPP DUE TO THE DEVICE NOT WORKING. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT. FURTHER INFORMATION WAS REQUESTED BUT NOT YET RECEIVED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7960948 ↗