AMS 700 CX 72404274Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00878953003818), received between Jun 3, 2019 and Sep 11, 2025 — classified as 6 injuries.

The most frequently reported specific device problem is “Material Puncture/Hole” (6 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjurySep 11, 2025Mechanical Problem; Nonstandard Device; Material Puncture/Hole; Mechanical Problem; Nonstandard Device; Material Puncture/Hole

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) WAS NOT PERFORMING AS EXPECTED. TWO WEEKS LATER A REVISION SURGERY WAS PERFORMED, UPON EXAMINATION A HOLE IN THE ONE CYLINDER WAS FOUND. THE IPP WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23033501 ↗
• InjuryJul 15, 2025Mechanical Problem; Nonstandard Device; Material Puncture/Hole; Adverse Event Without Identified Device or Use Problem; Mechanical Problem; Nonstandard Device; Material Puncture/Hole; Adverse Event Without Identified Device or Use Problem

  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 THAT THE RIGHT CYLINDER HAD A HOLE. THE CYLINDER WAS EXPLANTED AND REPLACED. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22508414 ↗
• InjuryJul 17, 2023Mechanical Problem; Material Puncture/Hole; Adverse Event Without Identified Device or Use Problem; Mechanical Problem; Material Puncture/Hole; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS SEEN BY THE PHYSICIAN AS THE INFLATABLE PENILE PROSTHESIS DID NOT WORK AS EXPECTED. TWO WEEKS LATER, THE PATIENT HAD THE INFLATABLE PENILE PROSTHESIS REPLACED DUE TO A CRACK IN THE CYLINDER CONNECTING TUBE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17336921 ↗
• InjuryFeb 21, 2023Mechanical Problem; Material Puncture/Hole; Adverse Event Without Identified Device or Use Problem; Mechanical Problem; Material Puncture/Hole; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS SEEN BY THE PHYSICIAN AS THE INFLATABLE PENILE PROSTHESIS DID NOT WORK AS EXPECTED. TWO WEEKS LATER, THE PATIENT HAD THE INFLATABLE PENILE PROSTHESIS REPLACED DUE TO A TEAR IN THE CYLINDER. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16414434 ↗
• InjuryDec 3, 2021Fluid/Blood Leak; Mechanical Problem; Material Puncture/Hole; Adverse Event Without Identified Device or Use Problem; Fluid/Blood Leak; Mechanical Problem; Material Puncture/Hole; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD THE INFLATABLE PENILE PROSTHESIS REMOVED AS THE DEVICE MALFUNCTIONED DUE TO FLUID LEAK FROM MULTIPLE HOLES IN THE CYLINDER. A NEW INFLATABLE PENILE PROSTHESIS CONSISTING OF CYLINDERS, PUMP, AND RESERVOIR WAS IMPLANTED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED AND THE PATIENT FULLY RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12925976 ↗
• InjuryJun 3, 2019Deflation Problem; Fluid/Blood Leak; Inflation Problem; Material Puncture/Hole; Deflation Problem; Fluid/Blood Leak; Inflation Problem; Material Puncture/Hole

  IT WAS REPORTED THAT THE PATIENT HAD THE INFLATABLE PENILE PROSTHESIS REMOVED DUE TO CYLINDER TEAR. A NEW INFLATABLE PENILE PROSTHESIS CONSISTING OF CYLINDERS, PUMP, AND RESERVOIR WERE IMPLANTED. FURTHER INFORMATION WAS REQUESTED AND NOT YET RECEIVED. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. ADDITIONAL INFORMATION RECEIVED INDICATED THE PATIENT HAD TROUBLE INFLATING OR DEFLATING THE DEVICE DUE TO A LACK OF SALINE INSIDE THE DEVICE. IT WAS INDICATED THAT THE PHYSICIAN MAY HAVE HIT THE SURFACE OF THE CYLINDER BY MISTAKE. THE PATIENT GOT WELL FOLLOWING THE REVISION SURGERY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8663515 ↗