AMS 700 CXR 72404014Recalls & reported problems

Summary

The FDA's MAUDE database contains 233 adverse event reports that list this exact device (DI 00878953002712), received between Nov 1, 2018 and Sep 30, 2026 — classified as 231 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Material Puncture/Hole” (154 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 233 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Material Deformation; Migration

  It was reported that patient experienced bulging and disfigurement in the penile body with the Inflatable Penile Prosthesis (IPP). Upon revision, physician noticed that the reservoir wasn't placed correctly and caused a bulge in the abdominal cavity. Per additional information, it was later reported that also the polyester braided layer inside the cylinder ruptured, resulting in column deformation. As a result, the device was explanted and replaced. No further complications were reported.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 50947808 ↗
• InjurySep 22, 2026Fluid/Blood Leak; Inflation Problem; Mechanical Problem

  It was reported that a patient with an Inflatable Penile Prosthesis (IPP) presented with a nonfunctioning device that would not inflate. A revision surgery was performed, during which the physician suspected a fluid leak within the system. The device was explanted and replaced. There were no patient complications.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50857421 ↗
• InjurySep 21, 2026Degraded; Mechanical Problem; Nonstandard Device

  It was reported that the Inflatable Penile Prosthesis (IPP) was not functioning. A revision procedure was performed, during which it was confirmed that the right cylinder had a bulge. All components were removed and replaced. No patient complications were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50843216 ↗
• InjurySep 8, 2026Mechanical Problem; Material Puncture/Hole

  It was reported that the patient went to the clinic because this Inflatable Penile Prosthesis (IPP) was not working properly. Two weeks later, a surgical procedure was performed, during which a hole in the cylinder was identified. The cause of the cylinder hole was not detailed by the hospital. All the components were removed and replaced. No patient complications were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50668391 ↗
• InjuryAug 31, 2026Migration

  It was reported that the patient's Inflatable Penile Prosthesis (IPP) cylinder protruded through the distal aspect of the penis. A surgical procedure was performed during which the IPP was explanted. Reimplantation of a new device was planned for a later date. It was reported that the extrusion was attributed to device displacement resulting from long-term wear. No additional patient complications were reported.

  Patient problems: Erosion; Unspecified Tissue Injury

  MAUDE report 50515458 ↗
• InjuryAug 24, 2026Mechanical Problem; Material Puncture/Hole

  It was reported that the patient's Inflatable Penile Prosthesis (IPP) was not functioning properly. During a surgical procedure, it was determined that the right cylinder had a hole. The right cylinder and pump were subsequently replaced. No patient complications were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50408010 ↗
• InjuryAug 11, 2026Fluid/Blood Leak

  It was reported that a patient with an Inflatable Penile Prosthesis (IPP) developed and infection, and the device exhibited fluid loss. A surgical procedure was performed to remove the IPP. No further patient complications were reported.

  Patient problems: Unspecified Infection

  MAUDE report 50209688 ↗
• InjuryJun 3, 2026Mechanical Problem; Nonstandard Device; Material Puncture/Hole

  IT WAS REPORTED THAT THE PATIENT WITH THIS INFLATABLE PENILE PROSTHESIS (IPP) PRESENTED TO THE HOSPITAL WITH A NON-FUNCTIONAL DEVICE. TWO WEEKS LATER, A SURGICAL PROCEDURE WAS PERFORMED AND UPON INSPECTION, THERE WAS A CRACK FOUND IN THE CYLINDER CONNECTING TUBE. AS A RESULT, THE PHYSICIAN REMOVED AND REPLACED THE ENTIRE DEVICE. THE PATIENT WAS STABLE FOLLOWING THE PROCEDURE, AND THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25379733 ↗
• InjuryMay 29, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A CYLINDER OF AN INFLATABLE PENILE PROSTHESIS (IPP) EXTRUDED THROUGH THE URETHRA. A SURGICAL PROCEDURE WAS PERFORMED, DURING WHICH INFECTIOUS LESIONS WERE IDENTIFIED IN THE SCROTUM AND URETHRAL TISSUE; AS A RESULT, THE DEVICE WAS REMOVED. NO FEVER OR SIGNIFICANT ABNORMALITIES IN ROUTINE BLOOD TESTING WERE REPORTED. IT WAS CONSIDERED THAT AN UNIDENTIFIED CHRONIC INFECTION INVOLVING THE URETHRAL MUCOSA MAY HAVE CONTRIBUTED TO THE EXTRUSION. A NEW IPP WAS IMPLANTED FOLLOWING RECOVERY.

  Patient problems: Erosion; Unspecified Infection

  MAUDE report 25333517 ↗
• InjuryApr 20, 2026Fluid/Blood Leak; Material Puncture/Hole

  IT WAS REPORTED THAT A PATIENT'S INFLATABLE PENILE PROSTHESIS (IPP) WAS LEAKING FLUID FROM THE CYLINDER FRONT END DUE TO A HOLE. THE DEVICE WAS EXPLANTED AND REPLACED. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24926999 ↗
• InjuryApr 8, 2026Mechanical Problem; Material Puncture/Hole

  IT WAS REPORTED THAT THE PATIENT'S INFLATABLE PENILE PROSTHESIS (IPP) WAS NOT FUNCTIONING PROPERLY. A SURGICAL PROCEDURE WAS PERFORMED DURING WHICH A HOLE WAS IDENTIFIED IN THE PUMP CONNECTING TUBE. THE PUMP WAS REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24818367 ↗
• InjuryMar 31, 2026Mechanical Problem; Nonstandard Device; Material Puncture/Hole

  IT WAS REPORTED THAT THE PATIENT'S INFLATABLE PENILE PROSTHESIS (IPP) WAS NOT FUNCTIONING PROPERLY. A SURGICAL PROCEDURE WAS PERFORMED, DURING WHICH A HOLE IN THE LEFT CYLINDER WAS IDENTIFIED. THE LEFT CYLINDER AND THE PUMP WERE REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24744496 ↗
• InjuryMar 26, 2026Mechanical Problem; Nonstandard Device; Material Puncture/Hole

  IT WAS REPORTED THAT THE PATIENT VISITED THE HOSPITAL BECAUSE HIS INFLATABLE PENILE PROSTHESIS (IPP) WAS NOT FUNCTIONING PROPERLY. THE PATIENT UNDERWENT SURGERY TWO WEEKS LATER AND UPON INSPECTION, A HOLE WAS IDENTIFIED IN THE LEFT CYLINDER. THE LEFT CYLINDER AND THE PUMP WERE EXPLANTED AND REPLACED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24698471 ↗
• InjuryMar 25, 2026Mechanical Problem; Nonstandard Device; Material Puncture/Hole

  IT WAS REPORTED THAT THE PATIENT WITH THIS INFLATABLE PENILE PROSTHESIS (IPP) WENT TO THE HOSPITAL BECAUSE THE PRODUCT WAS NOT FUNCTIONING PROPERLY. TWO WEEKS LATER UPON INSPECTION, IT WAS CONFIRMED THAT THE RIGHT CYLINDER HAD A HOLE, SO THE RIGHT CYLINDER AND THE PUMP WERE EXPLANTED AND REPLACED. NO ADDITIONAL INFORMATION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24693984 ↗
• InjuryMar 9, 2026Mechanical Problem; Nonstandard Device; Material Puncture/Hole

  IT WAS REPORTED THAT THE PATIENT VISITED THE HOSPITAL BECAUSE HIS INFLATABLE PENILE PROSTHESIS (IPP) WAS NOT FUNCTIONING PROPERLY. THE PATIENT UNDERWENT SURGERY TWO WEEKS LATER AND UPON INSPECTION, A HOLE WAS IDENTIFIED IN THE RIGHT CYLINDER. BOTH CYLINDERS AND THE PUMP WERE EXPLANTED AND REPLACED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24544739 ↗
• InjuryFeb 13, 2026Mechanical Problem; Nonstandard Device; Material Puncture/Hole

  IT WAS REPORTED THAT A PATIENT WITH AN INFLATABLE PENILE PROSTHESIS (IPP) IMPLANT DEVICE WENT TO THE HOSPITAL TWO WEEKS BEFORE THE OPERATION BECAUSE THE PRODUCT WAS NOT WORKING PROPERLY. UPON INSPECTION, CRACKS WERE FOUND IN THE CYLINDER AND THE PUMP CONNECTING TUBING. THE PHYSICIAN REMOVED AND REPLACED THE PUMP AND CYLINDER THROUGH REPLACEMENT SURGERY, THE PATIENT'S CONDITION WAS STABLE FOLLOWING THE PROCEDURE, AND THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24338860 ↗
• InjuryFeb 12, 2026Nonstandard Device; Material Puncture/Hole

  IT WAS REPORTED THAT A PATIENT WITH AN INFLATABLE PENILE PROSTHESIS (IPP) IMPLANT DEVICE WENT TO THE HOSPITAL TWO WEEKS BEFORE THE OPERATION BECAUSE THE PRODUCT WAS NOT WORKING PROPERLY. UPON INSPECTION, A RIGHT CYLINDER HOLE WAS FOUND BY THE PHYSICIAN. THE PHYSICIAN REMOVED AND REPLACED THE CYLINDERS AND PUMP THROUGH REPLACEMENT SURGERY, AND THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24329538 ↗
• InjuryFeb 4, 2026Nonstandard Device

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) EXHIBITED LOW CYLINDER STRENGTH; THEREFORE, A SURGICAL PROCEDURE WAS PERFORMED TO ADD ADDITIONAL SALINE TO THE CYLINDER. NO COMPONENTS WERE REMOVED DURING THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24256895 ↗
• InjuryFeb 4, 2026Mechanical 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 RIGHT CYLINDER WAS FOUND. THE PUMP AND RIGHT CYLINDER WERE EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24256891 ↗
• InjuryDec 23, 2025Mechanical Problem; Nonstandard Device; Material Puncture/Hole; Mechanical Problem; Nonstandard Device; Material Puncture/Hole

  IT WAS REPORTED THAT THE PATIENT VISITED THE HOSPITAL BECAUSE HIS INFLATABLE PENILE PROSTHESIS (IPP) WAS NOT FUNCTIONING PROPERLY. THE PATIENT UNDERWENT SURGERY TWO WEEKS LATER AND UPON INSPECTION, A CRACK WAS IDENTIFIED IN THE RIGHT CYLINDER CONNECTING TUBE. THE RIGHT CYLINDER AND THE PUMP WERE EXPLANTED AND REPLACED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23882963 ↗
• InjuryDec 22, 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 TEAR IN THE LEFT CYLINDER WAS FOUND. THE PUMP AND LEFT CYLINDER WERE EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23862792 ↗
• InjuryDec 18, 2025Inflation Problem; Air/Gas in Device; Inflation Problem; Air/Gas in Device

  IT WAS REPORTED THAT THE PATIENT'S INFLATABLE PENILE PROSTHESIS (IPP) EXHIBITED INFLATION ISSUES. DURING A SURGICAL PROCEDURE, AIR WAS OBSERVED INSIDE THE DEVICE. THE ENTIRE IPP WAS NOT REMOVED; ONLY THE QUICK-CONNECT COUPLING FROM AN ACCESSORY KIT WAS EXPLANTED. THE PATIENT'S CONDITION POST-PROCEDURE WAS STABLE, AND NO COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23840303 ↗
• InjuryDec 2, 2025Mechanical Problem; Nonstandard Device; Material Puncture/Hole; Mechanical Problem; Nonstandard Device; Material Puncture/Hole

  IT WAS REPORTED THAT THE PATIENT WENT TO THE CLINIC BECAUSE THIS INFLATABLE PENILE PROSTHESIS (IPP) WAS NOT WORKING PROPERLY. TWO WEEKS LATER, A SURGICAL PROCEDURE WAS PERFORMED, DURING WHICH A HOLE IN THE CYLINDER WAS FOUND. THE CAUSE OF THE CYLINDER HOLE WAS NOT DETAILED BY THE HOSPITAL. ALL THE COMPONENTS WERE REPLACED. THE ORIGINAL RESERVOIR WAS KEPT IN THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23694352 ↗
• InjuryNov 19, 2025Mechanical Problem; Material Puncture/Hole; Mechanical Problem; Material Puncture/Hole

  IT WAS REPORTED THAT THE PATIENT WITH THIS INFLATABLE PENILE PROSTHESIS (IPP) WENT TO THE HOSPITAL BECAUSE THE PRODUCT WAS NOT WORKING PROPERLY. TWO WEEKS LATER UPON INSPECTION, IT WAS CONFIRMED THAT THE CYLINDER HAD A HOLE, SO ALL COMPONENTS WERE REMOVED AND REPLACED. NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23598337 ↗
• InjuryNov 19, 2025Mechanical Problem; Nonstandard Device; Material Puncture/Hole; Mechanical Problem; Nonstandard Device; Material Puncture/Hole

  IT WAS REPORTED THAT THE PATIENT'S INFLATABLE PENILE PROSTHESIS (IPP) WAS NO FUNCTIONING PROPERLY. A SURGICAL PROCEDURE WAS PERFORMED, DURING WHICH WAS IDENTIFIED A TEAR IN THE RIGHT CYLINDER. ALL COMPONENTS WERE REMOVED AND REPLACED; THE CYLINDER WAS REPLACED ONLY ON THE RIGHT SIDE AND THE RESERVOIR THAT WAS KEPT IN THE PATIENT WAS NOT REMOVED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23595793 ↗