AMS 700 CXR 72404012Recalls & reported problems

Summary

The FDA's MAUDE database contains 212 adverse event reports that list this exact device (DI 00878953002699), received between Oct 24, 2018 and Sep 25, 2026 — classified as 211 injuries, 1 malfunction.

The most frequently reported specific device problem is “Material Puncture/Hole” (139 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 212 reports, in the reporter's own words as published by the FDA.

• InjurySep 25, 2026Insufficient Device Problem Information

  It was reported that the patient with an Inflatable Penile Prosthesis (IPP) had a cylinder eroded into the urethra and was associated with an infection. A revision procedure was performed during which the device was explanted. Following the procedure, the patient developed infectious symptoms. No additional information regarding the procedure outcome or event resolution was reported.

  Patient problems: Erosion; Perforation; Unspecified Infection

  MAUDE report 50893025 ↗
• InjurySep 8, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a patient with an Inflatable Penile Prosthesis (IPP) developed a fungus infection in the scrotum. A surgical procedure was performed to remove and replaced the IPP. The infection was treated with antibiotics. No further patient complications were reported.

  Patient problems: Unspecified Infection

  MAUDE report 50673191 ↗
• InjurySep 3, 2026Mechanical Problem; Material Puncture/Hole

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50599732 ↗
• InjurySep 1, 2026Mechanical Problem; Material Puncture/Hole

  It was reported that the patient's Inflatable Penile Prosthesis (IPP) was not functioning properly. During a surgical procedure, a hole was identified in the left cylinder. As a result, both cylinders and the pump were replaced. No patient complications were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50553494 ↗
• InjuryAug 31, 2026Fluid/Blood Leak

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

  Patient problems: Unspecified Infection

  MAUDE report 50533590 ↗
• InjuryAug 19, 2026Mechanical Problem; Material Puncture/Hole

  It was reported that the patient's Inflatable Penile Prosthesis (IPP) was not functioning properly. During a surgical procedure, a hole was identified in one of the cylinders. As a result, the IPP was fully replaced. No patient complications were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50326182 ↗
• InjuryAug 18, 2026Fluid/Blood Leak; Inflation Problem; Mechanical Problem

  It was reported that an Inflatable Penile Prosthesis (IPP) stopped functioning. The device could not be inflated despite multiple attempts to press the pump. A brightness-mode ultrasound was performed, during which it was identified that the reservoir was empty. A surgical procedure was performed to remove and replace the device. The cause of the fluid loss was not determined. No patient complications were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50306523 ↗
• InjuryJul 20, 2026Collapse; Mechanical Problem; Material Puncture/Hole

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) WAS NOT WORKING PROPERLY AND WAS NOT MAINTAINING NORMAL PRESSURIZATION. AS A RESULT, THE DEVICE WAS EXPLANTED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25880690 ↗
• InjuryJul 2, 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 RIGHT CYLINDER CONNECTING TUBE. THE RIGHT CYLINDER AND THE PUMP WERE REMOVED AND REPLACED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25699787 ↗
• InjuryJun 18, 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 HOLE FOUND IN THE LEFT CYLINDER. AS A RESULT, THE PHYSICIAN REMOVED AND REPLACED THE ENTIRE IPP. THE PATIENT WAS STABLE FOLLOWING THE PROCEDURE, AND THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25555722 ↗
• InjuryMar 24, 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 HOLE FOUND IN THE RIGHT CYLINDER. AS A RESULT, THE PHYSICIAN REMOVED AND REPLACED THE RIGHT CYLINDER. THE PATIENT WAS STABLE FOLLOWING THE PROCEDURE, AND THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24678143 ↗
• InjuryMar 6, 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 IPP WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24533652 ↗
• InjuryDec 30, 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 NOT WORKING PROPERLY. DURING A SURGICAL PROCEDURE, A HOLE WAS IDENTIFIED IN THE LEFT CYLINDER. BOTH CYLINDERS AND THE PUMP WERE REPLACED. THE PATIENT'S CONDITION FOLLOWING THE PROCEDURE IS STABLE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23928211 ↗
• InjuryDec 18, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A PATIENT WITH AN INFLATABLE PENILE PROSTHESIS (IPP) EXPERIENCED A URINARY TRACT INFECTION (UTI), WHICH LED TO URINARY RETENTION. THE PATIENT WAS HOSPITALIZED, AND A FOLEY CATHETER WAS INSERTED. THE URINARY RETENTION HAS NOT YET RESOLVED. ADDITIONALLY, THE UTI AND URINARY RETENTION WERE DETERMINED NOT TO BE RELATED TO THE DEVICE OR THE PROCEDURE, AS THE PHYSICIAN STATED THAT THE PATIENT DID NOT MAINTAIN GOOD HYGIENE AND THERE WERE NO SIGNS OF INFECTION BEFORE OR AFTER THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Urinary Retention; Urinary Tract Infection

  MAUDE report 23839093 ↗
• InjuryDec 17, 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 BOTH CYLINDERS AND THE PUMP WERE EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23825087 ↗
• InjuryDec 16, 2025Nonstandard Device; Material Puncture/Hole; Nonstandard Device; Material Puncture/Hole

  IT WAS REPORTED THAT A PATIENT WITH AN INFLATABLE PENILE PROSTHESIS (IPP) IMPLANT DEVICE PRESENTED TO THE HOSPITAL TWO WEEKS PRIOR TO SURGERY AND DURING EXAMINATION IT WAS OBSERVED THAT THERE WAS A CRACK IN THE RIGHT CYLINDER CONNECTION TUBE. THE PHYSICIAN REMOVED AND REPLACED THE RIGHT CYLINDER THROUGH REPLACEMENT SURGERY, AND THE PATIENT'S CONDITION WAS STABLE AND IMPROVED FOLLOWING THE SURGERY. THERE WERE NO FURTHER SIGNS OR SYMPTOMS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23822353 ↗
• InjuryDec 11, 2025Inflation Problem; Inflation 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 CYLINDER. NO COMPONENTS WERE REMOVED DURING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23783878 ↗
• InjuryDec 9, 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 TEAR IN THE CYLINDER WAS IDENTIFIED. THE CAUSE OF THE CYLINDER TEAR 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 23760667 ↗
• InjuryDec 2, 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 HOLE WAS IDENTIFIED IN THE 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 23691961 ↗
• InjuryNov 18, 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 HOLE 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 23580694 ↗
• InjuryNov 17, 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 CRACK IN THE CYLINDER CONNECTING TUBE WAS FOUND. THE PUMP AND BOTH CYLINDERS WERE EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23576349 ↗
• InjuryNov 13, 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 BECAUSE THE PRODUCT DID NOT WORK PROPERLY. TWO WEEKS LATER UPON INSPECTION, IT WAS CONFIRMED THAT THE RIGHT CYLINDER HAD A TEAR, SO THE RIGHT CYLINDER AND THE PUMP WERE EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23548879 ↗
• InjuryOct 24, 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 NOT FUNCTIONING PROPERLY. A SURGICAL PROCEDURE WAS PERFORMED DURING WHICH WAS IDENTIFIED A HOLE IN THE RIGHT CYLINDER. THE RIGHT CYLINDER AND THE PUMP WERE REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23381336 ↗
• InjuryOct 21, 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 HOLE WAS IDENTIFIED IN THE LEFT 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 23347388 ↗
• InjuryOct 15, 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 BECAUSE THE PRODUCT WAS NOT WORKING PROPERLY. TWO WEEKS LATER UPON INSPECTION, A CRACK WAS FOUND IN THE CYLINDER CONNECTING TUBE, SO BOTH CYLINDERS WERE REPLACED. NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23293449 ↗