AMS 700 Spherical Reservoir 72404156Recalls & reported problems

Summary

The FDA's MAUDE database contains 63 adverse event reports that list this exact device (DI 00878953003214), received between Jan 16, 2018 and Sep 28, 2026 — classified as 59 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Migration” (31 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 25 most recent of 63 reports, in the reporter's own words as published by the FDA.

• InjurySep 28, 2026Migration

  Patient problems: Pain

  MAUDE report 50918411 ↗
• InjuryAug 11, 2026Migration

  It was reported that the patient implanted with this Inflatable Penile Prosthesis (IPP) was dissatisfied because the reservoir tubing was palpable. A surgical revision procedure was performed, during which no device issue was identified, and the device was confirmed to be functioning as intended. However, the reservoir was removed and repositioned, with the tubing placed in a deeper location. No additional information was reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50209651 ↗
• InjuryAug 3, 2026Inflation Problem

  It was reported that the patient with this Inflatable Penile Prosthesis (IPP) was unable to inflate the device. During revision surgery, no fluid was observed moving into the cylinders. The device was disconnected from the reservoir, and surrogate testing was performed, after which the cylinders inflated. An attempt was made to aspirate fluid from the reservoir; however, no fluid could be retrieved. As a result, the reservoir was capped and retained in situ, and a new reservoir was implanted on the left side. Following implantation of the new reservoir, the device inflated properly. No patient complications were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50123761 ↗
• InjuryJun 5, 2026Migration

  IT WAS REPORTED THAT A PATIENT'S INFLATABLE PENILE PROSTHESIS (IPP) RESERVOIR PREVIOUSLY LOCATE IN THE SPACE OF RETZIUS WAS NOW PUSHING THE BLADDER. A SURGICAL PROCEDURE WAS PERFORMED, AND THE DEVICE WAS EXPLANTED AND REPLACED. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25415211 ↗
• InjuryMay 28, 2026Nonstandard Device

  IT WAS REPORTED THAT THE PATIENT WITH THIS INFLATABLE PENILE PROSTHESIS (IPP) EXPERIENCED DISSATISFACTION WITH THE RESERVOIR BULGE. A SURGICAL PROCEDURE WAS PERFORMED TO REPLACE THE RESERVOIR. NO DEVICE ISSUES WERE IDENTIFIED, AND NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25325637 ↗
• InjuryMay 27, 2026Migration

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) RESERVOIR HERNIATED. A SURGICAL PROCEDURE WAS PERFORMED DURING WHICH THE RESERVOIR WAS EXPLANTED AND REPLACED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25311221 ↗
• InjuryApr 29, 2026Migration

  IT WAS REPORTED THAT THE PATIENT WITH THIS INFLATABLE PENILE PROSTHESIS (IPP) EXPERIENCED A HERNIA ASSOCIATED WITH THE RESERVOIR. A SURGICAL PROCEDURE WAS PERFORMED IN WHICH THE EXISTING DEVICE WAS EXPLANTED AND REPLACED. THERE WERE NO FURTHER PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25038291 ↗
• InjuryApr 10, 2026Migration

  IT WAS REPORTED THAT THIS PATIENT WITH AN INFLATABLE PENILE PROSTHESIS (IPP) IMPLANT DEVICE EXPERIENCED BLADDER PAIN. A SURGICAL PROCEDURE WAS PERFORMED DURING WHICH THE RESERVOIR WAS EXPLANTED AND REPLACED. UPON EXPLANT, THE PHYSICIAN IDENTIFIED THAT THE RESERVOIR HAD ERODED INTO THE BLADDER. THERE WERE NO FURTHER PATIENT COMPLICATIONS REPORTED.

  Patient problems: Erosion; Pain

  MAUDE report 24841808 ↗
• InjuryApr 8, 2026Migration

  IT WAS REPORTED THAT THE PATIENT'S INFLATABLE PENILE PROSTHESIS (IPP) EXHIBITED A RESERVOIR MIGRATION, WHICH RESULTED IN A BOWEL OBSTRUCTION. A SURGICAL PROCEDURE WAS PERFORMED DURING WHICH THE RESERVOIR WAS REMOVED. IT WAS ALSO NOTED THAT THE CYLINDERS WERE LEFT SEMI-INFLATED, AND A METAL CAP WAS PLACED ON THE CYLINDER TUBING JUST BENEATH THE ABDOMINAL COUNTER INCISION. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Obstruction/Occlusion

  MAUDE report 24818373 ↗
• InjuryMar 9, 2026Nonstandard Device; Migration

  IT WAS REPORTED THAT THE RESERVOIR OF THIS INFLATABLE PENILE PROSTHESIS (IPP) WAS PRESSING ON THE PATIENT'S ILIAC VEIN. AS A RESULT, THE RESERVOIR WAS EXPLANTED AND REPLACED WITH A CONCEAL LOW-PROFILE RESERVOIR. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24551817 ↗
• MalfunctionNov 26, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT DURING AN INFLATABLE PENILE PROSTHESIS (IPP) IMPLANT PROCEDURE, WHEN THE OUTER PACKAGING OF A 100 ML SPHERICAL RESERVOIR WAS OPENED, A HAIR WAS OBSERVED INSIDE THE STERILE PACKAGING. THE STERILE BARRIER REMAINED SEALED WITH THE HAIR INSIDE. AS AN ALTERNATIVE, THE TEAM OPENED ANOTHER 100 ML CONCEAL RESERVOIR AND USED IT TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23657990 ↗
• InjuryNov 21, 2025Malposition of Device; Malposition of Device

  IT WAS REPORTED THAT THE PATIENT'S INFLATABLE PENILE PROSTHESIS (IPP) RESERVOIR WAS IMPROPERLY PLACED IN THE BLADDER, RESULTING IN EROSION. A SURGICAL PROCEDURE WAS PERFORMED TO REPLACE THE RESERVOIR. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Erosion

  MAUDE report 23622048 ↗
• InjuryJul 31, 2025Inflation Problem; Migration; Inflation Problem; Migration

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) PRESENTED DEVICE AUTO INFLATING, UPON EXPLANTING THE DEVICE, IT WAS REALIZED THE RESERVOIR MIGRATED DOWN INTO THE GROIN SCROTUM AREA, AND THAT IS WHAT WAS CAUSING THE AUTO INFLATION. THE IPP WAS REPLACED. THERE IS NO ADDITIONAL INFORMATION REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22674790 ↗
• InjuryJul 11, 2025Malposition of Device; Malposition of Device

  IT WAS REPORTED THAT THE PATIENT WITH AN INFLATABLE PENILE PROSTHESIS (IPP) CAN FEEL THE RESERVOIR. A SURGICAL PROCEDURE WAS PERFORMED TO REMOVE AND REPLACE THE RESERVOIR. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22487924 ↗
• InjuryJun 20, 2025Migration; Migration

  IT WAS REPORTED THAT THE RESERVOIR OF THIS INFLATABLE PENILE PROSTHESIS (IPP) MIGRATED. THE RESERVOIR WAS RELOCATED. THERE IS NO ADDITIONAL INFORMATION REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22299004 ↗
• InjuryJun 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WITH THIS INFLATABLE PENILE PROSTHESIS (IPP) EXPERIENCED RESERVOIR EROSION INTO THE BLADDER AND PAIN. THE RESERVOIR WAS EXPLANTED AND REPLACED. THERE IS NO ADDITIONAL INFORMATION REPORTED.

  Patient problems: Erosion; Pain; Perforation

  MAUDE report 22233282 ↗
• InjuryApr 29, 2025Migration; Migration

  IT WAS REPORTED THAT THE INFLATABLE PENILE PROSTHESIS (IPP) RESERVOIR HERNIATED FROM THE PATIENTS LEFT TO RIGHT SIDE, AND IT BECAME DIFFICULT TO PUMP AND PALPABLE. A SURGICAL PROCEDURE WAS PERFORMED TO TRACE THE TUBING AND A COUNTER INCISION TO DELIVER THE RESERVOIR AND REPLACE FOR A NEW CONCEAL ECTOPIC RESERVOIR ON THE RIGHT SIDE. THERE WERE NO FURTHER PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21930683 ↗
• InjuryMar 25, 2025Fluid/Blood Leak; Inflation Problem; Mechanical Problem; Material Puncture/Hole; Device Contamination with Chemical or Other Material; Fluid/Blood Leak; Inflation Problem; Mechanical Problem; Material Puncture/Hole; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) WAS NOT INFLATING, AND IT WAS DIFFICULT TO PUMP, THE DEVICE PRESENTED A FLUID LOSS SINCE IT REPORTED HOLE AT RESERVOIR SEAL, DEVICE CONTAINED BLOOD AND TISSUE. THE IPP WAS EXPLANTED AND REPLACED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21693970 ↗
• InjuryFeb 6, 2025Migration; Migration

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) RESERVOIR MIGRATED TO THE SCROTUM. A SURGICAL PROCEDURE WAS PERFORMED, DURING WHICH THE COMPONENT WAS REMOVED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21322316 ↗
• InjuryJan 8, 2025Migration; Migration

  IT WAS REPORTED THAT THE RESERVOIR OF THIS INFLATABLE PENILE PROSTHESIS (IPP) HERNIATED. THE RESERVOIR WAS REMOVED AND REPLACED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21106930 ↗
• InjuryJan 2, 2025Mechanical Problem; Unintended Deflation; Mechanical Problem; Unintended Deflation

  IT WAS REPORTED THAT THE PUMP OF THIS INFLATABLE PENILE PROSTHESIS (IPP) WAS NOT WORKING PROPERLY. IT SEEMED THAT THE CYLINDER FLUID WAS RECYCLING BACK TO THE PUMP SPONTANEOUSLY. THE PATIENT EXPERIENCED DIFFICULTY PUMPING DEVICE. THE IPP WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21056453 ↗
• InjuryDec 3, 2024Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) WAS NOT INFLATING; THEREFORE, IT WAS REMOVED AND REPLACED. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20832302 ↗
• InjurySep 12, 2024Mechanical Problem; Material Deformation; Mechanical Problem; Material Deformation

  IT WAS REPORTED THAT THE PATIENT WITH THIS INFLATABLE PENILE PROSTHESIS WAS DISSATISFIED DUE TO INADEQUATE RIGIDITY. THE TUBING OF THE RESERVOIR WAS KINKED. THE RESERVOIR WAS REMOVED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20200677 ↗
• InjuryAug 28, 2024Migration; Migration

  IT WAS REPORTED THAT THE PATIENT WITH THIS INFLATABLE PENILE PROSTHESIS (IPP) PRESENTED AT THE EMERGENCY ROOM SHORTLY AFTER IMPLANT OF THE DEVICE WITH PAIN IN THE LEFT GROIN. UPON EVALUATION, IT WAS FOUND THAT THE RESERVOIR HAD MIGRATED BEHIND THE PUBIC BONE. A SURGICAL PROCEDURE WAS PERFORMED WHERE THE RESERVOIR WAS REMOVED AND REPLACED WITH A NEW ONE. THE PUMP AND CYLINDERS REMAINED IMPLANTED. THERE WERE NO ADDITIONAL PATIENT COMPLICATIONS REPORTED.

  Patient problems: Pain

  MAUDE report 20087017 ↗
• InjuryAug 14, 2024Malposition of Device; Migration; Malposition of Device; Migration

  IT WAS REPORTED THAT THE PATIENT WITH THIS INFLATABLE PENILE PROSTHESIS (IPP) HAD THE RESERVOIR REPLACED DUE TO IT HERNIATING. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: Hernia; Unspecified Tissue Injury

  MAUDE report 19982640 ↗