AMS 700 CXR 72404011Recalls & reported problems

Summary

The FDA's MAUDE database contains 60 adverse event reports that list this exact device (DI 00878953002682), received between Oct 12, 2018 and Jul 27, 2026 — classified as 57 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Material Puncture/Hole” (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 60 reports, in the reporter's own words as published by the FDA.

• InjuryJul 27, 2026Fluid/Blood Leak; Material Puncture/Hole; Air/Gas in Device

  It was reported that the tubing connection between the cylinder and the pump of this Inflatable Penile Prosthesis (IPP) ruptured, resulting in fluid leakage near the pump connection. As a result, the device was explanted and replaced. No patient complications were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50037979 ↗
• InjuryJun 18, 2026Mechanical Problem; Nonstandard Device; Material Puncture/Hole

  IT WAS REPORTED THAT A PATIENT WITH AN INFLATABLE PENILE PROSTHESIS (IPP) PRESENTED WITH A NONFUNCTIONING DEVICE. A REVISION SURGERY WAS PERFORMED, DURING WHICH THE PHYSICIAN CONFIRMED A CRACK IN THE CYLINDER CONNECTING TUBE. THE DEVICE COMPONENTS WERE EXPLANTED AND REPLACED, WHILE THE RESERVOIR REMAINED IMPLANTED AND WAS NOT REPLACED. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25556137 ↗
• InjuryJan 12, 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 WAS IDENTIFIED A HOLE IN THE LEFT CYLINDER. THE LEFT CYLINDER AND THE PUMP WERE REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24046958 ↗
• InjurySep 5, 2025Mechanical Problem; Mechanical Problem

  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 RESERVOIR. NO COMPONENTS WERE REMOVED DURING THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22979620 ↗
• InjuryAug 25, 2025Mechanical Problem; Nonstandard Device; Material Puncture/Hole; Mechanical Problem; Nonstandard Device; Material Puncture/Hole

  IT WAS REPORTED THAT THE PATIENT WITH THIS INFLATABLE PENILE PROSTHESIS (IPP) WENT TO THE HOSPITAL TWO WEEKS BEFORE THE OPERATION BECAUSE THE PRODUCT DID NOT WORK PROPERLY. AS A RESULT OF THE INSPECTION, IT WAS CONFIRMED THAT THE LEFT CYLINDER HAD A HOLE, SO BOTH CYLINDERS WERE REPLACED. THE CAUSE OF THE CYLINDER HOLE WAS NOT DETAILED BY THE HOSPITAL. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22889634 ↗
• InjuryJun 25, 2025Mechanical Problem; Material Puncture/Hole; Mechanical Problem; 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 CRACK IN THE RIGHT CYLINDER CONNECTING TUBE WAS FOUND. THE PUMP WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22328806 ↗
• InjuryApr 7, 2025Mechanical Problem; Material Puncture/Hole; Adverse Event Without Identified Device or Use Problem; Mechanical Problem; Material Puncture/Hole; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS WAS NOT WORKING PROPERLY. TWO WEEKS LATER, A SURGICAL PROCEDURE WAS PERFORMED, DURING WHICH A CRACK IN THE LEFT CYLINDER CONNECTING TUBE WAS NOTED. ALL COMPONENTS WERE REMOVED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21785408 ↗
• InjuryJan 10, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INFLATABLE PENILE PROSTHESIS (IPP) REPAIR SURGERY. THE EXISTING IPP WAS REMOVED WITH NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Purulent Discharge; Unspecified Infection

  MAUDE report 21124076 ↗
• InjuryJul 30, 2024Mechanical Problem; Material Puncture/Hole; Adverse Event Without Identified Device or Use Problem; Mechanical Problem; Material Puncture/Hole; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) STOPPED WORKING AS INTENDED. TWO WEEKS LATER, SURGICAL INTERVENTION TOOK PLACE TO REVISE THE DEVICE, AND A HOLE WAS FOUND IN THE RIGHT CYLINDER. THE PUMP AND RIGHT CYLINDER WERE REPLACED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19860607 ↗
• InjuryJun 24, 2024Mechanical Problem; Material Puncture/Hole; Adverse Event Without Identified Device or Use Problem; Mechanical Problem; Material Puncture/Hole; Adverse Event Without Identified Device or Use Problem

  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 CYLINDERS WAS FOUND. THE RESERVOIR WAS NOT REMOVED, AND THE CYLINDERS WERE EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19600934 ↗
• InjuryMay 23, 2024Defective Device; Defective 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 RESERVOIR. NO COMPONENTS WERE REMOVED DURING THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19387845 ↗
• InjuryMay 20, 2024Collapse; Mechanical Problem; Adverse Event Without Identified Device or Use Problem; Collapse; Mechanical Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) WAS NOT WORKING AS INTENDED. THE PUMP WOULD REMAIN DIMPLED WHEN SQUEEZED. SURGICAL INTERVENTION WAS PERFORMED TO REPLACE THE PUMP AND CYLINDERS. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19355502 ↗
• InjuryMay 20, 2024Mechanical Problem; Material Puncture/Hole; Mechanical Problem; 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 LEFT CYLINDER WAS FOUND. THE LEFT CYLINDER WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19355193 ↗
• InjuryMay 14, 2024Migration; Migration

  IT WAS REPORTED THAT THE CYLINDER OF THIS INFLATABLE PENILE PROSTHESIS (IPP) PERFORATED THE DISTAL END OF THE PATIENT'S PENIS. A SURGICAL PROCEDURE WAS PERFORMED TO REMOVE THE CYLINDER. THERE WERE NO FURTHER PATIENT COMPLICATIONS REPORTED.

  Patient problems: Perforation

  MAUDE report 19310487 ↗
• InjuryMar 21, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT WITH THIS INFLATABLE PENILE PROSTHESIS (IPP) DEVELOPED AN INFECTION. THE IPP WAS EXPLANTED, AND AT A LATER DATE, A NEW IPP WAS IMPLANTED. THERE WERE NO ADDITIONAL PATIENT COMPLICATIONS REPORTED.

  Patient problems: Unspecified Infection

  MAUDE report 18956423 ↗
• InjuryDec 19, 2023Mechanical Problem; Material Puncture/Hole; Adverse Event Without Identified Device or Use Problem; Mechanical Problem; Material Puncture/Hole; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) WAS NOT WORKING AS INTENDED. TWO WEEKS LATER A REVISION SURGERY WAS PERFORMED, UPON EXAMINATION A CRACK IN THE RIGHT CYLINDER CONNECTING TUBE 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 18357549 ↗
• InjuryDec 8, 2023Mechanical Problem; Material Puncture/Hole; Adverse Event Without Identified Device or Use Problem; Mechanical Problem; Material Puncture/Hole; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) WAS NOT WORKING PROPERLY. TWO WEEKS LATER A REVISION SURGERY WAS PERFORMED, UPON EXAMINATION A CRACK IN THE PUMP CONNECTING TUBE WAS FOUND. THE DEVICE WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18291188 ↗
• InjuryAug 31, 2023Mechanical Problem; Material Puncture/Hole; Mechanical Problem; Material Puncture/Hole

  IT WAS REPORTED THAT THE PATIENT WENT TO THE HOSPITAL DUE TO THE INFLATABLE PENILE PROSTHESIS (IPP) NOT WORKING APPROPRIATELY. TWO WEEKS LATER, A REPLACEMENT SURGERY WAS PERFORMED. IT WAS NOTED THAT DURING THE PROCEDURE, THE EXISTING PUMP AND CYLINDERS WERE REMOVED AND REPLACED; HOWEVER, THE PREVIOUS RESERVOIR WAS LEFT IN PLACE AND A NEW COMPONENT WAS IMPLANTED. UPON EXPLANT, A TEAR WAS SEEN IN THE CYLINDER. THE CAUSE FOR THE CYLINDER HOLE WAS NOT DETAILED BY THE FACILITY. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17666848 ↗
• InjuryAug 15, 2023Break; Mechanical Problem; Break; Mechanical Problem

  IT WAS REPORTED THAT THE PATIENT WAS SEEN BY THE PHYSICIAN AS THE INFLATABLE PENILE PROSTHESIS (IPP) DID NOT WORK AS EXPECTED. TWO WEEKS LATER, THE IPP WAS REMOVED AND REPLACED DUE TO A CRACK IN THE PUMP CONNECTOR. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17553087 ↗
• InjuryAug 14, 2023Material Puncture/Hole; Adverse Event Without Identified Device or Use Problem; Material Puncture/Hole; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD THE INFLATABLE PENILE PROSTHESIS REMOVED DUE TO A MACRO PUNCTURE IN THE CYLINDER. A NEW INFLATABLE PENILE PROSTHESIS WAS IMPLANTED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17544667 ↗
• InjuryJun 7, 2023Mechanical Problem; Material Puncture/Hole; Mechanical Problem; Material Puncture/Hole

  IT WAS REPORTED THAT THE PATIENT WENT TO THE HOSPITAL DUE TO THE INFLATABLE PENILE PROSTHESIS (IPP) NOT WORKING APPROPRIATELY. TWO WEEKS LATER A SURGICAL PROCEDURE WAS PERFORMED IN WHICH THE EXISTING DEVICE WAS REMOVED AND REPLACED. UPON EXPLANT, A HOLE WAS IDENTIFIED IN THE LEFT CYLINDER; HOWEVER, ITS CAUSE WAS NOT DETAILED BY THE FACILITY. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17083252 ↗
• InjuryMar 17, 2023Defective Device; Defective Device

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INFLATABLE PENILE PROSTHESIS (IPP) REPLACEMENT SURGERY DUE TO THE DEVICE NOT PERFORMING AS EXPECTED. THE CYLINDERS WERE REMOVED AND REPLACED. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16566338 ↗
• InjuryMar 16, 2023Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT THE PATIENT HAD THEIR INFLATABLE PENILE PROSTHESIS (IPP) REPLACED DUE TO THE INITIAL DEVICE BEING TOO SHORT AND TOO SMALL TO PERFORM THE TASK AS THE PATIENT HAD EXTENSIVE FIBROSIS. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: Fibrosis

  MAUDE report 16559089 ↗
• InjuryMar 14, 2023Inadequacy of Device Shape and/or Size; Defective Device; Inadequacy of Device Shape and/or Size; Defective Device

  IT WAS REPORTED THAT THE PATIENT UNDERWENT SURGICAL INTERVENTION TO EXPLANT THE INFLATABLE PENILE PROSTHESIS (IPP) DUE TO IT THE DEVICE NOT BEING LONG ENOUGH FOR THE PATIENT. DURING THE ORIGINAL IMPLANT, THE PHYSICIAN FOUND THAT THE PATIENT HAD FIBROSIS AND REQUIRED DILATION TO IMPLANT THE IPP. LATER, THE PATIENT EXPERIENCED ISSUES WITH THE DEVICE NOT BEING LONG ENOUGH TO EXTEND INTO THE GLANS RESULTING IN DIFFICULTY WITH SEXUAL INTERCOURSE. NEW LONGER CYLINDERS WERE IMPLANTED, AND THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16539944 ↗
• InjuryFeb 22, 2023Mechanical Problem; Material Puncture/Hole; Mechanical Problem; Material Puncture/Hole

  IT WAS REPORTED THAT THE PATIENT VISITED THE HOSPITAL BECAUSE HIS INFLATABLE PENILE PROSTHESIS (IPP) DID NOT PERFORM AS EXPECTED. THE PATIENT UNDERWENT SURGERY TWO WEEKS LATER AND INSPECTION REVEALED A CRACK IN THE RIGHT CYLINDER CONNECTING TUBE. THEREFORE, THE CYLINDER AND PUMP WERE REMOVED AND REPLACED. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16423112 ↗