AMS 700 CX MS Pump 72404288Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00878953003917), received between Aug 29, 2023 and Jun 8, 2026 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Inflation Problem” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJun 8, 2026Collapse; Fluid/Blood Leak; Inflation Problem; Mechanical Problem

  IT WAS REPORTED THAT A PATIENT WITH AN INFLATABLE PENILE PROSTHESIS (IPP) PRESENTED WITH DEVICE MALFUNCTION, BEING UNABLE TO INFLATE OR DEFLATE THE DEVICE. VENTRAL PENILE CURVATURE AND DISCOMFORT WERE ALSO REPORTED, ASSOCIATED WITH THE PRESENCE OF TUBING AND THE POSITIONING OF THE RESERVOIR. ADDITIONALLY, FLUID LOSS WAS IDENTIFIED IN THE CYLINDERS AND PUMP, AND THE PUMP REMAINED FLAT. SURGERY WAS SCHEDULED FOR RECONSTRUCTION OF THE CORPORA AND REPLACEMENT OF THE PROSTHESIS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Deformity/ Disfigurement; Discomfort

  MAUDE report 25436594 ↗
• InjuryMar 25, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WITH THIS INFLATABLE PENILE PROSTHESIS (IPP) STATED HE EXPERIENCED AN INFECTION. HE WAS FEBRILE AND REQUIRED AMBULANCE TRANSPORT TO THE EMERGENCY ROOM. HE RECEIVED IV ANTIBIOTICS AND TESTED POSITIVE FOR PSEUDOMONAS AERUGINOSA. HE WAS DISCHARGED HOME ON ANTIBIOTICS BUT CONTINUED TO EXPERIENCE SWELLING AND A 90 DEGREE PENILE CURVATURE. A FEW DAYS LATER, HE UNDERWENT A SURGICAL WASHOUT OF THE DEVICE WITH DRAIN PLACEMENT. AT A RECENT FOLLOW UP VISIT, THE STITCHES WERE REMOVED AND THE SITE WAS ASSESSED; HOWEVER, SWELLING AND PENILE CURVATURE PERSISTED. THE DEVICE REMAINS IMPLANTED, AND THE PATIENT WILL CONTINUE FOLLOW UP WITH HIS PHYSICIAN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Bacterial Infection; Deformity/ Disfigurement; Fever; Swelling/ Edema

  MAUDE report 24691889 ↗
• MalfunctionAug 29, 2023Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT SIX WEEKS AFTER AN INFLATABLE PENILE PROSTHESIS (IPP) WAS IMPLANTED, IT WAS NOTED THAT THE LEFT CYLINDER WAS NOT INFLATING. A RESONANCE EXAM WAS PERFORMED, AND IT WAS CONFIRMED THAT THE LEFT CYLINDER WAS NOT INFLATING AS EXPECTED. A SURGICAL PROCEDURE WAS REQUESTED TO ADDRESS THE EXPERIENCE. HOWEVER, IT HAS NOT BEEN SCHEDULED YET. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17639924 ↗