AMS 700 CXR 72404013Recalls & reported problems

Summary

The FDA's MAUDE database contains 381 adverse event reports that list this exact device (DI 00878953002705), received between Oct 18, 2018 and Sep 24, 2026 — classified as 377 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Material Puncture/Hole” (230 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 381 reports, in the reporter's own words as published by the FDA.

• InjurySep 24, 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 tear was identified in the right cylinder. All components were explanted and replaced. There were no patient complications reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50885563 ↗
• InjurySep 4, 2026Insufficient Device Problem Information

  It was reported that a patient with an Inflatable Penile Prosthesis (IPP) developed a collection of pus in the tissue. A surgical procedure was performed to remove the IPP. No further patient complications were reported.

  Patient problems: Purulent Discharge

  MAUDE report 50612085 ↗
• InjurySep 1, 2026Inflation Problem

  It was reported that a patient's Inflatable Penile Prosthesis (IPP) exhibited inflation issues observed in the cylinders and pump due to a blockage in either the cylinders or the pump. A surgical procedure was performed to replace the preconnect. No patient complications were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Pain

  MAUDE report 50553503 ↗
• InjuryAug 14, 2026Mechanical Problem; Material Puncture/Hole

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50256052 ↗
• InjuryJul 17, 2026Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT WITH THIS INFLATABLE PENILE PROSTHESIS (IPP) EXPERIENCED INFECTION. AS A RESULT, THE DEVICE WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Bacterial Infection; Fluid Discharge; Pain; Unspecified Infection

  MAUDE report 25856078 ↗
• InjuryJul 15, 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 CYLINDER CONNECTING TUBE. ALL COMPONENTS WERE REMOVED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25833739 ↗
• InjuryJun 22, 2026Fluid/Blood Leak; Inflation Problem

  IT WAS REPORTED THAT WHILE REPEATEDLY PRESSING THE CONTROL SWITCH ON THE PUMP OF THE INFLATABLE PENILE PROSTHESIS (IPP) IT WOULD REBOUND NORMALLY BUT THE CYLINDER HAD NO RESPONSE AND WOULD NOT INFLATE NORMALLY. A SURGICAL PROCEDURE WAS PERFORMED DURING WHICH THE DEVICE WAS EXPLANTED AND REPLACED. UPON EXPLANT THE PHYSICIAN NOTICED WATER WAS REDUCED IN THE RESERVOIR. THE PATIENT WAS STABLE FOLLOWING THE PROCEDURE, AND THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25588548 ↗
• InjuryJun 9, 2026Inflation Problem

  IT WAS REPORTED THAT AN INFLATABLE PENILE PROSTHESIS (IPP) EXHIBITED INFLATION ISSUES DESPITE THE PUMP BEING SQUEEZED WITH NORMAL REBOUND OBSERVED. A SURGICAL PROCEDURE WAS PERFORMED, DURING WHICH THE RESERVOIR WAS REMOVED AND LATER ALL COMPONENTS WERE REMOVED AND REPLACED. NO COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25446904 ↗
• InjuryJun 9, 2026Fluid/Blood Leak; Mechanical Problem; Material Puncture/Hole

  IT WAS REPORTED THAT AN INFLATABLE PENILE PROSTHESIS (IPP) WAS NOT FUNCTIONING PROPERLY. A SURGICAL PROCEDURE WAS PERFORMED, DURING WHICH A DAMAGED CYLINDER WAS IDENTIFIED. AS A RESULT, THE DEVICE WAS REMOVED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25446892 ↗
• InjuryMay 29, 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 CYLINDER. AS A RESULT, THE PHYSICIAN REMOVED AND REPLACED ALL COMPONENTS. THE PATIENT WAS STABLE FOLLOWING THE PROCEDURE, AND NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25340697 ↗
• InjuryMay 13, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS PATIENT WITH AN INFLATABLE PENILE PROSTHESIS (IPP) UNDERWENT A SURGICAL PROCEDURE DUE TO AN INFLAMMATORY REACTION. THE PHYSICIAN REMOVED AND REPLACED THE DEVICE, AND THERE WERE NO FURTHER PATIENT COMPLICATIONS REPORTED.

  Patient problems: Inflammation

  MAUDE report 25166476 ↗
• InjuryApr 29, 2026Mechanical Problem; Material Puncture/Hole

  IT WAS REPORTED THAT THE PATIENT'S INFLATABLE PENILE PROSTHESIS (IPP) WAS NOT FUNCTIONING PROPERLY. DURING SURGICAL INTERVENTION, A CRACK WAS IDENTIFIED IN THE RIGHT CYLINDER CONNECTING TUBING. ALL IPP COMPONENTS WERE REMOVED, WITH THE EXCEPTION OF THE RESERVOIR, WHICH WAS LEFT IN PLACE. A NEW IPP WAS SUBSEQUENTLY IMPLANTED, AND NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25029611 ↗
• InjuryApr 28, 2026Collapse; Inflation Problem; Air/Gas in Device

  IT WAS REPORTED THAT THE CYLINDERS OF AN INFLATABLE PENILE PROSTHESIS (IPP) COULD NOT BE INFLATED. AIR WAS OBSERVED WITHIN THE DEVICE, AND THE PUMP REMAINED FLAT. SUBSEQUENTLY, A SURGICAL PROCEDURE WAS PERFORMED TO REMOVE AND REPLACE THE IPP. NO COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25015871 ↗
• InjuryApr 15, 2026Mechanical Problem; 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 TEAR FOUND IN THE LEFT CYLINDER. AS A RESULT, THE PHYSICIAN REMOVED AND REPLACED THE LEFT CYLINDER AND PUMP. THE PATIENT WAS STABLE FOLLOWING THE PROCEDURE, AND THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24891813 ↗
• InjuryApr 9, 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, AND NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24834517 ↗
• InjuryApr 2, 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 IDENTIFIED CRACKS IN THE CYLINDER CONNECTING TUBE. THE DEVICE WAS EXPLANTED AND REPLACED WITH A TACTRA DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24767736 ↗
• InjuryFeb 24, 2026Degraded; Mechanical Problem; Nonstandard Device

  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 THAT THAT THE RIGHT CYLINDER HAD A BALLOONING. THE DEVICE WAS EXPLANTED AND REPLACED. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24431755 ↗
• InjuryJan 28, 2026Mechanical 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 CRACKS IN THE CYLINDER AND PUMP CONNECTING TUBE WERE IDENTIFIED. THE CAUSE OF THE CRACKS WAS NOT DETAILED BY THE HOSPITAL. THE CYLINDERS AND PUMP WERE REMOVED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24201526 ↗
• InjuryJan 27, 2026Nonstandard Device; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WITH THIS INFLATABLE PENILE PROSTHESIS (IPP) PRESENTED WITH FEVER AND INFECTION RESULTING IN THE DISCHARGE OF PUS. THE PATIENT WAS TREATED WITH ANTIBIOTICS. THE IPP WAS EXPLANTED AND REPLACED. THERE IS NO ADDITIONAL INFORMATION REPORTED.

  Patient problems: Fever; Purulent Discharge; Unspecified Infection

  MAUDE report 24193720 ↗
• InjuryJan 19, 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 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 24111847 ↗
• InjuryJan 16, 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 LEFT CYLINDER WAS FOUND. THE LEFT CYLINDER, PUMP AND RESERVOIR WERE REMOVED AND REPLACED, WHILE THE EXISTING RESERVOIR WAS KEPT IN THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24096666 ↗
• InjuryJan 15, 2026Mechanical Problem; 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. ALL COMPONENTS WERE EXPLANTED AND REPLACED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24082283 ↗
• InjuryJan 7, 2026Mechanical Problem; Material Puncture/Hole

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23989022 ↗
• InjuryDec 29, 2025Nonstandard Device; Insufficient Device Problem Information; Nonstandard Device; Insufficient Device Problem Information

  THIS PRODUCT WAS RETURNED TO THE MANUFACTURER WITHOUT ANY REPORT OF PERFORMANCE ISSUES OR ADVERSE PATIENT EFFECTS. THE RETURNED DEVICE WAS ANALYZED AND A PRODUCT DEFICIENCY WAS IDENTIFIED. SEE ADDITIONAL MANUFACTURER NARRATIVE FOR FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23912600 ↗
• InjuryDec 29, 2025Migration; Migration

  IT WAS REPORTED THAT THE PATIENT WITH THIS INFLATABLE PENILE PROSTHESIS (IPP) PRESENTED WITH INFECTION AND ONE SIDE OF THE CYLINDER CAME OUT OF THE URETHRA, THE INFECTION WAS TREATED WITH ANTIBIOTICS. THE IPP WAS EXPLANTED AND REPLACED. THERE IS NO ADDITIONAL INFORMATION REPORTED.

  Patient problems: Perforation; Unspecified Infection

  MAUDE report 23906789 ↗