AMS 700 Spherical Reservoir 72404162Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00878953003245), received between Nov 5, 2018 and Jun 10, 2024 — classified as 5 injuries.

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

• InjuryJun 10, 2024Defective Device; Migration; Defective Device; Migration

  IT WAS REPORTED THAT THE PATIENT WITH THIS INFLATABLE PENILE PROSTHESIS (IPP) WAS NOT SATISFIED WITH THE DEVICE. THE IMPLANT PRODUCED AN "S" SHAPED DEFORMITY, AND THE RESERVOIR MIGRATED TO A POSITION THAT WAS PALPABLE TO THE PATIENT. THE PHYSICIAN BELIEVED THAT THE S SHAPE COULD HAVE BEEN A SIZING ISSUE. THE IPP WAS REPLACED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19505262 ↗
• InjurySep 23, 2021Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THE PATIENT HAD A SURGICAL PROCEDURE TO REPLACE AN INFLATABLE PENILE PROSTHESIS (IPP) DUE TO A PUNCTURE IN THE RESERVOIR. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12518154 ↗
• InjuryMar 30, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING AN INFLATABLE PENILE PROSTHESIS (IPP) RESERVOIR PLACEMENT IN THE PRE-VESICAL SPACE, THE HEART RATE OF THE PATIENT BECAME UNSTABLE. THE PROCEDURE WAS STOPPED AND THE RESERVOIR REMOVED. THE PATIENT WAS STABILIZED BUT THE SURGICAL TEAM DID NOT WANT TO CONTINUE WITH THE INTERVENTION UNTIL THE PATIENT GETS A CARDIO ASSESSMENT. THE PATIENT WAS STABLE AND WELL FOLLOWING THE PROCEDURE. IT WAS UNKNOWN IF THE PATIENT WOULD PROCEED WITH A REVISION AT A LATER DATE.

  Patient problems: Arrhythmia

  MAUDE report 11588243 ↗
• InjuryNov 24, 2020Fluid/Blood Leak; Inflation Problem; Material Puncture/Hole; Fluid/Blood Leak; Inflation Problem; Material Puncture/Hole

  IT WAS REPORTED THAT THE PATIENT HAD THE INFLATABLE PENILE PROSTHESIS REPLACED DUE TO FLUID LOSS FROM THE RESERVOIR AND THE CYLINDERS WOULD NOT INFLATE. THE RESERVOIR HAD A VISIBLE HOLE RESULTING IN FLUID LOSS. FOLLOWING THE SURGERY, THE PATIENT WAS STABLE AND WELL. THE EVENT RESOLVED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10892420 ↗
• InjuryNov 5, 2018Insufficient Device Problem Information; Migration; Insufficient Device Problem Information; Migration

  IT WAS REPORTED THAT THE PATIENT HAD AN INFLATABLE PENILE PROSTHESIS THAT WAS REMOVED AND REPLACED DUE TO PATIENT DISSATISFACTION OF THE PAIN DUE TO THE RESERVOIR WAS PUSHED THROUGH THE PATIENT'S ABDOMEN, EXTERNALIZING THE RESERVOIR AND EROSION.

  Patient problems: Erosion; Pain

  MAUDE report 8040146 ↗