AMS 700 CX MS Pump 72404287Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00878953003900), received between Jul 10, 2020 and Jan 8, 2025 — classified as 5 injuries.

The most frequently reported specific device problem is “Inflation Problem” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJan 8, 2025Inflation Problem; Mechanical Problem; Defective Device; Inflation Problem; Mechanical Problem; Defective Device

  IT WAS REPORTED THAT THE PATIENT WITH THIS INFLATABLE PENILE PROSTHESIS (IPP) PRESENTED FLOPPY GLANS AND THE DEVICE NOT WORKING AS INTENDED DUE TO INFLATION ISSUES. THE PATIENT STATED HE FELT HE WAS NOT PROPERLY EDUCATED OR GIVEN CLEAR EXPECTATIONS. IN ADDITION, HE FELT MISLED BY THE MATERIALS AND RESOURCES PROVIDED PRIOR TO THE OPERATION. WHEN DEVICE IS FULLY INFLATED, THE DISTAL CYLINDER TIPS ARE 1.5 IN BELOW THE TIP OF HIS PENIS AND ARE UNEVEN IN LENGTH. HOWEVER, THE PATIENT SERVICES SPECIALIST VERIFIED THAT THE CORPORAL MEASUREMENTS ALIGN WITH THE IMPLANTED CYLINDER AND REAR TIP EXTENDERS. THE PATIENT CONSULTED A UROLOGIST, BUT SINCE HE DOES NOT SPECIALIZE IN IPPS, AND INDICATED THAT HE WOULD PASS THE INFORMATION TO THE IMPLANT PHYSICIAN; HOWEVER, THE PATIENT HAS NOT RECEIVED ANY FOLLOW-UP FROM EITHER DOCTOR AND IS INCREASINGLY ANXIOUS. PATIENT SERVICES SPECIALIST SUGGESTED AN APPOINTMENT WITH THE IMPLANT PHYSICIAN OR TRYING TO SEE A DIFFERENT UROLOGIST FOR DEVICE EVALUATION. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Anxiety; Deformity/ Disfigurement

  MAUDE report 21102249 ↗
• InjuryJul 17, 2024Inflation Problem; Defective Device; Material Deformation; Inflation Problem; Defective Device; Material Deformation

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) WAS NOT RIGID ENOUGH DUE TO THE PUMP NOT BEING ABLE TO BE PUSHED MORE THAN THREE TIMES. A SURGICAL PROCEDURE WAS PERFORMED TO REMOVE THE DEVICE, DURING WHICH IT WAS NOTED THAT THE TUBING WAS KINKED AND THERE WAS SCAR TISSUE PREVENTING THE RIGHT CYLINDER FROM INFLATING. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Scar Tissue

  MAUDE report 19767676 ↗
• InjuryJan 5, 2022Collapse; Difficult or Delayed Activation; Collapse; Difficult or Delayed Activation

  IT WAS REPORTED THAT THE PATIENT IS EXPERIENCING A FLAT INFLATABLE PENILE PROSTHESIS (IPP) PUMP. DURING ACTIVATION, THE PUMP STAYED FLAT AND DID NOT REFILL. THE PHYSICIAN TRIED TO UNLOCK THE PUMP BUT WAS UNSUCCESSFUL, AND RECOMMENDS A SURGERY TO EXPLANT THE DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13173287 ↗
• InjuryFeb 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED INFECTION WITH AN INFLATABLE PENILE PROSTHESIS (IPP). IT WAS INDICATED THAT THE INFECTION WAS LOCATED IN THE SCROTUM AND FOLLOWED THE TUBING. THE PHYSICIAN BELIEVED THE DEVICE CONTRIBUTED TO THE INFECTION BUT THE ONSET OF THE SYMPTOMS WAS UNKNOWN. A SURGICAL PROCEDURE WAS PERFORMED IN WHICH THE EXISTING IPP WAS REMOVED AND A NEW TACTRA PENILE PROSTHESIS WAS IMPLANTED. THERE WERE NO DEVICE MALFUNCTIONS ASSOCIATED WITH THE EXPLANTED DEVICE AND THE PATIENT DID NOT EXPERIENCE FURTHER COMPLICATIONS. THE POST-OPERATIONAL ANTIBIOTIC TREATMENT INFORMATION WAS UNAVAILABLE.

  Patient problems: Unspecified Infection

  MAUDE report 11328115 ↗
• InjuryJul 10, 2020Fluid/Blood Leak; Inflation Problem; Adverse Event Without Identified Device or Use Problem; Fluid/Blood Leak; Inflation Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT COMPLAINED THAT THE CYLINDERS COULD NOT BE INFLATED DUE TO FLUID LOSS. THE PATIENT HAD THE INFLATABLE PENILE PROSTHESIS REMOVED AND DAMAGE TO ONE CYLINDER WAS DETECTED, ALTHOUGH THE PHYSICIAN WAS UNABLE TO PINPOINT THE CAUSE OF THE FLUID LOSS. A NEW INFLATABLE PENILE PROSTHESIS WAS IMPLANTED, THE PATIENT WAS STABLE FOLLOWING THE SURGERY AND THE EVENT RESOLVED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10258124 ↗