AMS 700 Spherical Reservoir 72404155Recalls & reported problems

Summary

The FDA's MAUDE database contains 120 adverse event reports that list this exact device (DI 00878953003207), received between Dec 21, 2017 and Sep 22, 2026 — classified as 109 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Migration” (41 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 120 reports, in the reporter's own words as published by the FDA.

• InjurySep 22, 2026Migration

  It was reported that the reservoir of this Inflatable Penile Prosthesis (IPP) migrated from the prevesical space into the patient's perineum. A surgical procedure was performed during which the existing reservoir was explanted and replaced with a new one. There were no patient complications reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50855109 ↗
• InjuryJun 23, 2026Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Discomfort

  MAUDE report 25602212 ↗
• InjuryMar 16, 2026Migration

  IT WAS REPORTED THAT THE PATIENT IMPLANTED WITH THIS INFLATABLE PENILE PROSTHESIS (IPP) UNDERWENT A SURGICAL PROCEDURE DUE TO RESERVOIR MIGRATION. THE EXISTING COMPONENT WAS EXPLANTED AND REPLACED WITH A NEW RESERVOIR. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24613900 ↗
• InjuryMar 11, 2026Deflation Problem; Mechanical Problem

  IT WAS REPORTED THAT A PATIENT'S ARTIFICIAL URINARY SPHINCTER (AUS) RESERVOIR WAS FOLDED AND ALL FLUID WAS TRAPPED IN THE CYLINDERS. THE DEVICE WOULD NOT PUMP; IT WAS FULLY INFLATED AT ALL TIMES. THE RESERVOIR WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24567960 ↗
• InjuryFeb 4, 2026Mechanical Problem; Material Deformation; Migration

  IT WAS REPORTED THAT THE PATIENT'S INFLATABLE PENILE PROSTHESIS (IPP) WAS NOT FUNCTIONING PROPERLY WITH ISSUES NOTED IN THE PUMP MECHANISM. DURING THE SURGICAL PROCEDURE, IT WAS ALSO DISCOVERED THAT THE RESERVOIR HAD MIGRATED FROM ITS INTENDED POSITION. THE PHYSICIAN SUSPECTED THAT THE TUBING WAS KINKED, AS THE DEVICE FUNCTIONED APPROPRIATELY ONCE TENSION WAS APPLIED TO THE TUBING. THIS CONFIRMED THAT THE PUMP ITSELF WAS OPERATING CORRECTLY. DESPITE THIS, THE PHYSICIAN ELECTED TO REPLACE THE TENACIO PUMP WITH AN MS PUMP AND ALSO REPLACED THE RESERVOIR. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24258056 ↗
• InjuryFeb 2, 2026Migration

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24232707 ↗
• InjuryJan 21, 2026Fluid/Blood Leak; Inflation Problem; Material Puncture/Hole

  IT WAS REPORTED THAT THE PATIENT WITH AN INFLATABLE PENILE PROSTHESIS (IPP) IMPLANT DEVICE WAS UNABLE TO GET AN ERECTION WITH THE IMPLANT DUE TO THERE BEING NO SALINE SOLUTION WITHIN THE RESERVOIR DUE TO DAMAGE ON THE RESERVOIR TUBING. THE PHYSICIAN REMOVED AND REPLACED THE ENTIRE DEVICE THROUGH REPLACEMENT SURGERY, AND THERE WERE NO PATIENT SIGNS OR SYMPTOMS REPORTED AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24141479 ↗
• InjuryNov 14, 2025Connection Problem; Migration; Connection Problem; Migration

  IT WAS REPORTED THAT THE RESERVOIR OF THIS INFLATABLE PENILE PROSTHESIS (IPP) MIGRATED AND DISCONNECTED. THE PATIENT EXPERIENCED PAIN WHEN PASSING STOOL. AS A RESULT, THE RESERVOIR WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS REPORTED.

  Patient problems: Pain

  MAUDE report 23554660 ↗
• InjuryOct 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S INFLATABLE PENILE PROSTHESIS (IPP) WAS REPLACED DUE TO AN INFECTION VISIBLE AT THE LOCATION OF THE RESERVOIR. THE INFECTION WAS TREATED WITH A LOT OF ANTIBIOTIC SOLUTION TO WASH THE INFECTED AREA. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Unspecified Infection

  MAUDE report 23375952 ↗
• InjurySep 19, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE PUMP OF THIS INFLATABLE PENILE PROSTHESIS (IPP) WAS NOT FUNCTIONING PROPERLY. A SURGICAL PROCEDURE WAS PERFORMED IN WHICH THE DEVICE WAS REMOVED AND REPLACED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23096690 ↗
• InjuryAug 7, 2025Migration; Migration

  IT WAS REPORTED THAT THE RIGHT CYLINDER OF THIS INFLATABLE PENILE PROSTHESIS (IPP) MIGRATED OUT OF CORPORA DUE TO BAD TISSUE AND LACK OF CAPSULE FORMATION. THE IPP WAS EXPLANTED AND REPLACED. THERE IS NO ADDITIONAL INFORMATION REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22745377 ↗
• InjuryJul 9, 2025Fluid/Blood Leak; Inflation Problem; Fluid/Blood Leak; Inflation Problem

  IT WAS REPORTED THAT THE INFLATABLE PENILE PROSTHESIS (IPP) WAS NOT INFLATING, AND IT WAS NOTICED A FLUID LOSS. A SURGICAL PROCEDURE WAS PERFORMED TO REPLACE THE SYSTEM. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22465363 ↗
• InjuryJun 19, 2025Fluid/Blood Leak; Inflation Problem; Material Puncture/Hole; Adverse Event Without Identified Device or Use Problem; Air/Gas in Device; Fluid/Blood Leak; Inflation Problem; Material Puncture/Hole; Adverse Event Without Identified Device or Use Problem; Air/Gas in Device

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) WAS NO LONGER INFLATING. ADDITIONALLY, AIR IN THE SYSTEM WAS NOTED, ALONG WITH FLUID LOSS DUE TO A HOLE IN THE RESERVOIR HUB. THE IPP WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22294529 ↗
• InjuryJun 3, 2025Fluid/Blood Leak; Mechanical Problem; Fluid/Blood Leak; Mechanical Problem

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) PRESENTED A MECHANICAL PROBLEM, IT WAS REPORTED A FLUID LOSS IN THE RESERVOIR. THE IPP WAS EXPLANTED AND REPLACED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22135103 ↗
• InjuryMar 27, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE INFLATABLE PENILE PROSTHESIS (IPP) PUMP WAS NOT CYCLING DUE A FLUID LOSS FROM THE RESERVOIR. A SURGICAL PROCEDURE WAS PERFORMED TO REPLACE THE SYSTEM. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21708348 ↗
• InjuryFeb 25, 2025Migration; Migration

  IT WAS REPORTED THAT THE PATIENT WITH THIS INFLATABLE PENILE PROSTHESIS EXPERIENCED HERNIATION IN THE RESERVOIR. A SURGICAL PROCEDURE WAS PERFORMED DURING WHICH THE EXISTING RESERVOIR WAS REMOVED AND REPLACED. THERE WERE NO FURTHER PATIENT COMPLICATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21458185 ↗
• InjuryJan 10, 2025Fluid/Blood Leak; Adverse Event Without Identified Device or Use Problem; Fluid/Blood Leak; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE RESERVOIR OF THIS INFLATABLE PENILE PROSTHESIS (IPP) PRESENTED WITH A LEAK. THE IPP WAS EXPLANTED AND REPLACED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21124206 ↗
• InjuryJan 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE RESERVOIR OF THIS INFLATABLE PENILE PROSTHESIS (IPP) RETURNED WITHOUT INITIAL REPORTER AND ANY PERFORMANCE ALLEGATION. UPON ANALYSIS OF THE RETURNED COMPONENT, IT WAS NOTED THAT THE RESERVOIR FAILED THE MICROSCOPE EXAMINATION AND THE LEAKAGE TEST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21075334 ↗
• InjuryDec 12, 2024Inadequacy of Device Shape and/or Size; Migration; Inadequacy of Device Shape and/or Size; Migration

  IT WAS REPORTED THAT THE RESERVOIR OF THIS INFLATABLE PENILE PROSTHESIS (IPP) MIGRATED AND THE CYLINDERS WERE INCORRECTLY SIZED. THE IPP WAS EXPLANTED AND REPLACED. THERE WERE NO ADDITIONAL PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20918169 ↗
• InjuryDec 5, 2024Migration; Migration

  IT WAS REPORTED THAT THIS PATIENT UNDERWENT AN INFLATABLE PENILE PROSTHESIS (IPP) SURGICAL PROCEDURE DUE TO MIGRATION OF THE RESERVOIR. THEREFORE, THE COMPONENT WAS REMOVED AND REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20857370 ↗
• InjuryDec 2, 2024Fluid/Blood Leak; Mechanical Problem; Fluid/Blood Leak; Mechanical Problem

  IT WAS REPORTED THAT THE RESERVOIR AND PUMP OF THIS INFLATABLE PENILE PROSTHESIS (IPP) WERE NOT WORKING PROPERLY DUE TO A TOTAL LOSS OF FLUID FROM THE RESERVOIR. A SURGICAL PROCEDURE WAS PERFORMED TO REMOVE AND REPLACE BOTH COMPONENTS. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20821342 ↗
• InjuryNov 12, 2024Migration; Migration

  IT WAS REPORTED THAT THE PATIENT WITH THIS INFLATABLE PENILE PROSTHESIS (IPP) STATED THAT THE DEVICE WAS UNCOMFORTABLE. HE FELT A "POP" A FEW MONTHS AGO IN HIS ABDOMEN. THE RESERVOIR HAD MIGRATED FROM ORIGINAL PLACE TO JUST UNDER HIS SKIN. THE RESERVOIR WAS REMOVED AND REPLACED. THERE WERE NO ADDITIONAL PATIENT COMPLICATIONS.

  Patient problems: Discomfort

  MAUDE report 20668520 ↗
• InjuryOct 17, 2024Migration; Migration

  IT WAS REPORTED THAT THE INFLATABLE PENILE PROSTHESIS RESERVOIR MIGRATED TO AN UNDESIRABLE LOCATION. THE PATIENT UNDERWENT SURGERY AND THE RESERVOIR WAS REPLACED IN A NEW CONTRALATERAL SPACE AND CONNECTED TO THE EXISTING SYSTEM. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20472537 ↗
• InjuryOct 16, 2024Mechanical Problem; Defective Device; Mechanical Problem; Defective Device

  IT WAS REPORTED THAT THE PATIENT STATED THIS INFLATABLE PENILE PROSTHESIS (IPP) WAS NOT WORKING PROPERLY, AS THE PUMP BECAME HARDER TO PUMP. A SURGICAL PROCEDURE WAS PERFORMED, DURING WHICH A CAPSULE AROUND THE RESERVOIR WAS NOTED. ALL COMPONENTS WERE REMOVED AND REPLACED. THERE WERE NO FURTHER PATIENT COMPLICATIONS REPORTED.

  Patient problems: Capsular Contracture

  MAUDE report 20463413 ↗
• InjuryOct 14, 2024Migration; Migration

  IT WAS REPORTED THAT THE PATIENT WITH THIS INFLATABLE PENILE PROSTHESIS (IPP) EXPERIENCED EROSION AND DISCOMFORT AS THE RESERVOIR HERNIATED AND EXTRUDED TO THE ABDOMEN. A SURGICAL PROCEDURE WAS PERFORMED TO REMOVE AND REPLACE THE DEVICE. THERE WERE NO FURTHER PATIENT COMPLICATIONS REPORTED.

  Patient problems: Discomfort; Erosion

  MAUDE report 20438348 ↗