AMS 700 CX 72404173Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00878953003276), received between Dec 1, 2020 and Oct 15, 2025 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Component Missing” (1 report).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryOct 15, 2025Fluid/Blood Leak; Mechanical Problem; Fluid/Blood Leak; Mechanical Problem

  IT WAS REPORTED THAT THE PATIENT WITH THIS INFLATABLE PENILE PROSTHESIS (IPP) WAS EXPERIENCING A MECHANICAL ISSUE. DURING THE PROCEDURE, FLUID LOSS WAS IDENTIFIED IN THE RIGHT CYLINDER. BOTH THE OUTER SILICONE WALL AND THE INNER DACRON LAYER WERE FOUND TO BE RUPTURED. THE CYLINDER WAS DIFFICULT TO REMOVE AS TISSUE HAD BECOME INCORPORATED BETWEEN THE LAYERS, WHICH CAUSED ADDITIONAL DAMAGE DURING REMOVAL. ALL COMPONENTS WERE REPLACED, AND THE DEVICE WAS DISPOSED. THERE WERE NO FURTHER PATIENT COMPLICATIONS REPORTED.

  Patient problems: Capsular Contracture

  MAUDE report 23294381 ↗
• InjuryApr 22, 2022Migration; Migration

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THEIR PHYSICIAN WITH A PENILE DEFORMITY RELATED TO THIS INFLATABLE PENILE PROSTHESIS (IPP). UPON EXAMINATION, IT WAS DETERMINED THAT THE LEFT CYLINDER HAD MIGRATED AND EXTRUDED THROUGH THE CAVERNOSUM AT THE SITE OF THE CORPOROTOMY. IT WAS NOTED THAT THE CYLINDER STILL INFLATED AS EXPECTED, BUT WAS SITTING UNDER THE SKIN RATHER THAN WITHIN THE CAVERNOSUM. THE PATIENT HAS BEEN SCHEDULED FOR A PROCEDURE ON A FUTURE DATE TO SURGICALLY ADDRESS THE ISSUE. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Erosion; Perforation

  MAUDE report 14190602 ↗
• InjuryOct 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A SURGICAL PROCEDURE TO REMOVE THIS INFLATABLE PENILE PROSTHESIS (IPP) DUE TO SCROTAL INFECTION AND EROSION; IT WAS NOTED THE PUMP COULD BE VISUALIZED OUTSIDE THE SCROTUM. THE IPP WAS EXPLANTED AND REPLACED WITH A TACTRA MALLEABLE PROSTHESIS. THE PATIENT FULLY RECOVERED.

  Patient problems: Erosion; Unspecified Infection

  MAUDE report 12600641 ↗
• MalfunctionDec 1, 2020Component Missing; Component Missing

  IT WAS REPORTED THAT UPON OPENING PACKAGE, THEY REALIZED IT WAS CYLINDERS ONLY WITHOUT A PRE-ATTACHED MS PUMP. PHYSICIAN WANTED A PRE-ATTACHED SYSTEM. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE WITHOUT PATIENT COMPLICATIONS RELATED O DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10927028 ↗