AMS 700 LGX 72404291Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00878953003931), received between Apr 16, 2019 and Aug 26, 2026 — classified as 8 injuries.

The most frequently reported specific device problem is “Material Puncture/Hole” (7 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryAug 26, 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 crack was found in the pump connecting tube, so the pump was replaced. No patient complications were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50460815 ↗
• InjuryFeb 13, 2024Mechanical Problem; Material Puncture/Hole; Mechanical Problem; Material Puncture/Hole

  IT WAS REPORTED THAT THE PATIENT WAS SEEN BY THE PHYSICIAN AS THE INFLATABLE PENILE PROSTHESIS DID NOT WORK AS EXPECTED. TWO WEEKS LATER, THE INFLATABLE PENILE PROSTHESIS WAS REMOVED AND REPLACED DUE TO A HOLE IN THE CYLINDER. THE OLD RESERVOIR REMAINS IN SITU BUT NOT IN USE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18694351 ↗
• InjuryJan 25, 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 PROPERLY. TWO WEEKS LATER, A REPLACEMENT SURGERY WAS PERFORMED. UPON EXPLANT, A CRACK WAS IDENTIFIED IN THE RIGHT CYLINDER CONNECTING TUBE; HOWEVER, THE CAUSE OF THE HOLE WAS NOT DETAILED BY THE FACILITY. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16242410 ↗
• InjurySep 13, 2022Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE HOSPITAL WITH AN INFLATABLE PENILE PROSTHESIS (IPP) THAT WAS NOT FUNCTIONING PROPERLY. AT A LATER DATE, THE CYLINDER AND PUMP WERE EXPLANTED AND REPLACED WITH A NEW CYLINDER AND PUMP. UPON EXPLANT, A CRACK WAS FOUND IN THE CYLINDER CONNECTING TUBE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15414754 ↗
• InjuryFeb 8, 2022Mechanical 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 THE PATIENT HAD A SURGICAL PROCEDURE TO REPLACE AN INFLATABLE PENILE PROSTHESIS (IPP) SINCE THE DEVICE DID NOT WORK. A CRACK WAS FOUND IN THE PUMP CONNECTOR TUBE, AND THE PUMP WAS REPLACED. THE CAUSE OF THE PUMP CONNECTING TUBE CRACK IS UNKNOWN. AFTER THE PROCEDURE, THE PATIENT IMPROVED AND THE PATIENT OUTCOME WAS REPORTED STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13491690 ↗
• InjuryOct 11, 2021Mechanical 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 THE PATIENT WAS SEEN BY THE PHYSICIAN AS THE INFLATABLE PENILE PROSTHESIS DID NOT WORK AS EXPECTED. TWO WEEKS LATER, THE PATIENT HAD THE INFLATABLE PENILE PROSTHESIS CYLINDERS AND PUMP COMPONENTS REPLACED DUE TO A HOLE IN THE CYLINDER. FOLLOWING THE SURGERY, THE PATIENT WAS STABLE, IMPROVED AND THE EVENT RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12606042 ↗
• InjuryJun 7, 2021Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THE PATIENT HAD THE INFLATABLE PENILE PROSTHESIS REMOVED DUE TO A MICRO PUNCTURE IN THE CYLINDER. A NEW INFLATABLE PENILE PROSTHESIS CONSISTING OF CYLINDERS, PUMP, AND RESERVOIR WAS IMPLANTED. FOLLOWING THE REPLACEMENT SURGERY, THE EVENT RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11946762 ↗
• InjuryApr 16, 2019Deflation Problem; Fluid/Blood Leak; Inflation Problem; Mechanical Problem; Deflation Problem; Fluid/Blood Leak; Inflation Problem; Mechanical Problem

  IT WAS REPORTED THAT THE INFLATABLE PENILE PROSTHESIS (IPP) CYLINDERS AND PUMP WERE EXPLANTED BECAUSE THE TUBING BETWEEN THE CYLINDERS AND PUMP HAD BECOME DISCONNECTED. NEW 15CM X 12MM CYLINDERS AND A NEW PUMP WERE IMPLANTED. IT WAS FURTHER REPORTED THAT THE CAUSE OF THE DISCONNECTION OF THE TUBING WAS NOT FOUND. IN ADDITION TO THE DISCONNECTION THERE WAS FLUID LOSS FROM THE DEVICE. TWO WEEKS PRIOR TO SURGERY THE PATIENT HAD DIFFICULTY INFLATING AND DEFLATING THE DEVICE DUE TO THE FLUID LOSS. THE PATIENT WAS DOING WELL FOLLOWING THE SURGERY. PRODUCT WAS EXPLANTED AND EXPECTED TO BE RETURNED. A SUPPLEMENTAL REPORT WILL BE FILED AFTER PRODUCT HAS BEEN RETURNED AND PRODUCT ANALYSIS HAS BEEN COMPLETED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8520499 ↗