AMS 700 CXR MS Pump 72404263Recalls & reported problems

Summary

The FDA's MAUDE database contains 98 adverse event reports that list this exact device (DI 00878953003719), received between Oct 12, 2018 and Sep 25, 2026 — classified as 93 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (27 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 98 reports, in the reporter's own words as published by the FDA.

• InjurySep 25, 2026Deflation Problem

  It was reported that this Inflatable Penile Prosthesis (IPP) was not deflating. Upon inspection, scarring and corporal damage were noticed. As a result, the device was explanted. No patient complications were reported.

  Patient problems: Scar Tissue; Unspecified Tissue Injury

  MAUDE report 50893081 ↗
• InjurySep 7, 2026Collapse; Fluid/Blood Leak; Inflation Problem; Air/Gas in Device

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50651235 ↗
• InjurySep 1, 2026Collapse; Fluid/Blood Leak; Inflation Problem; Air/Gas in Device

  Patient problems: Unspecified Tissue Injury

  MAUDE report 50553505 ↗
• InjuryMay 20, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WITH THIS INFLATABLE PENILE PROSTHESIS (IPP) EXPERIENCED CYLINDER EROSION THROUGH THE URETHRA. A SURGICAL INTERVENTION WAS PERFORMED, DURING WHICH NO DEVICE RELATED ISSUES WERE IDENTIFIED. THE IPP WAS EXPLANTED AND FULLY REPLACED. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Erosion

  MAUDE report 25232705 ↗
• InjuryMar 26, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WITH THIS INFLATABLE PENILE PROSTHESIS (IPP) EXPERIENCED DISTAL URETHRAL EROSION ASSOCIATED WITH THE RIGHT CYLINDER. A SURGICAL PROCEDURE WAS PERFORMED IN WHICH THE CYLINDERS AND PUMP WERE EXPLANTED AND REPLACED, WHILE THE RESERVOIR WAS RETAINED. THE EROSION SITE WAS REPAIRED. THERE WERE NO FURTHER PATIENT COMPLICATIONS REPORTED.

  Patient problems: Erosion

  MAUDE report 24698465 ↗
• InjuryMar 4, 2026Fluid/Blood Leak; Mechanical Problem

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) WAS NOT WORKING AND EXHIBITED FLUID LOSS. A SURGICAL PROCEDURE WAS PERFORMED TO REMOVE AND REPLACE THE CYLINDERS AND PUMP. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24512545 ↗
• InjuryJan 21, 2026Inflation Problem

  IT WAS REPORTED THAT A PATIENT WITH AN INFLATABLE PENILE PROSTHESIS (IPP) PRESENTED WITH DIFFICULTY USING THE PUMP. A REVISION SURGERY WAS PERFORMED, DURING WHICH THE PHYSICIAN EXPLANTED THE DEVICE AND IMPLANTED A MALLEABLE PENILE PROSTHESIS. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24141578 ↗
• InjuryJan 15, 2026Inflation Problem; Connection Problem; Air/Gas in Device

  IT WAS REPORTED THAT THE PATIENT'S INFLATABLE PENILE PROSTHESIS (IPP) CYLINDER EXHIBITED INFLATION ISSUES. DURING SURGERY, TESTING OF THE RESERVOIR AND PUMP SHOWED THAT THE RESERVOIR CONTAINED NO FLUID AND AIR WAS PRESENT IN THE PUMP. AS NO LEAKS WERE IDENTIFIED, THE PHYSICIAN DETERMINED THAT THE MOST LIKELY CAUSE WAS A CONNECTION ISSUE. THE RESERVOIR WAS REFILLED AND SUCCESSFULLY TESTED, AND NO COMPONENTS WERE REPLACED DURING THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24078490 ↗
• InjuryJan 13, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WITH AN INFLATABLE PENILE PROSTHESIS (IPP) EXPERIENCED EROSION IN THE SCROTUM AND THE TUBING WAS EXPOSED. A SURGICAL PROCEDURE WAS PERFORMED TO REMOVE THE IPP AND REPLACE IT WITH A TACTRA. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Erosion

  MAUDE report 24061438 ↗
• InjuryDec 11, 2025Mechanical Problem; Mechanical Problem

  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 EXPLANTED AND REPLACED THE DEVICE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23777677 ↗
• InjuryNov 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Pain; Unspecified Infection

  MAUDE report 23667623 ↗
• InjuryNov 26, 2025Inflation Problem; Migration; Inflation Problem; Migration

  IT WAS REPORTED THAT THE PATIENT WITH AN INFLATABLE PENILE PROSTHESIS (IPP) STATED THAT THE PUMP WAS DIFFICULT TO REACH AND INFLATE, AND WAS RIDING UPWARD WITHIN THE SCROTUM. AS A RESULT, THE PUMP WAS EXPLANTED AND REPLACED WITH LONGER TUBING TO ALLOW FOR SECURE PLACEMENT IN A LOWER LOCATION WITHIN THE SCROTUM. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23661035 ↗
• InjuryOct 15, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A PATIENT WITH AN INFLATABLE PENILE PROSTHESIS (IPP) UNDERWENT A REVISION SURGERY, DURING WHICH THE PHYSICIAN CONFIRMED THAT IMPLANT WAS COMPLETELY VOID OF FLUID WHEN EXPLANTED. THE DEVICE WAS REPLACED, AND THE OLD RESERVOIR WAS DRAINED AND RETAINED. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23286604 ↗
• InjuryOct 1, 2025Fluid/Blood Leak; Mechanical Problem; Fluid/Blood Leak; Mechanical Problem

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) PRESENTED A MECHANICAL PROBLEM DUE TO A FLUID LOSS IN THE CYLINDERS. THE IPP WAS EXPLANTED AND REPLACED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23192814 ↗
• InjuryAug 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WITH THIS INFLATABLE PENILE PROSTHESIS (IPP) PRESENTED DISCOMFORT AND INFECTION. THE INFECTION TREATED WITH ANTIBIOTICS. THE IPP WAS EXPLANTED. THERE IS NO ADDITIONAL INFORMATION REPORTED.

  Patient problems: Discomfort; Unspecified Infection

  MAUDE report 22845674 ↗
• InjuryJul 16, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE CYLINDER OF THIS INFLATABLE PENILE PROSTHESIS (IPP) HAD FLUID LOSS. THE PUMP AND CYLINDERS WERE REMOVED AND REPLACED. NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22519014 ↗
• InjuryJun 25, 2025Material 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 UNDERWENT AN INFLATABLE PENILE PROSTHESIS (IPP) REVISION SURGERY DUE TO A RUPTURE IN THE LEFT CYLINDER. THE COMPONENTS WERE REMOVED AND REPLACED NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22328543 ↗
• InjuryMay 15, 2025Migration; Migration

  IT WAS REPORTED THAT THE PATIENT STATED THIS INFLATABLE PENILE PROSTHESIS (IPP) PUMP IS SITING HIGH IN HIS SCROTUM MAKING IT DIFFICULT ACCESS FOR PROPER INFLATION. PHYSICIAN SUGGESTED HIM THAT THE COMPONENT MAY LOWER IN TIME. NO ADDITIONAL INFORMATION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22029550 ↗
• InjuryMay 13, 2025Inflation Problem; Unintended Deflation; Inflation Problem; Unintended Deflation

  IT WAS REPORTED THAT THE PATIENT HAD HARD TIMES INFLATING HIS INFLATABLE PENILE PROSTHESIS (IPP) DUE TO THE PUMP BEING HARD TO SQUEEZE. IT WAS ALSO CONFIRMED THE IMPLANT AUTO-DEFLATES DURING INTERCOURSE SOMETIMES, BUT DOCTOR WAS ABLE TO INFLATE AND DEFLATE NORMALLY. A SURGICAL PROCEDURE WAS PERFORMED TO REPLACE THE PUMP FOR A TENACIO PUMP. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22007610 ↗
• InjuryMar 4, 2025Fluid/Blood Leak; Mechanical Problem; Fluid/Blood Leak; Mechanical Problem

  IT WAS REPORTED THAT THE PUMP OF THIS INFLATABLE PENILE PROSTHESIS WAS NOT WORKING. THE DEVICE HAD FLUID LOSS. THE CYLINDERS WERE EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21512132 ↗
• InjuryJan 24, 2025Inflation Problem; Mechanical Problem; Adverse Event Without Identified Device or Use Problem; Inflation Problem; Mechanical Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CYLINDERS OF THIS INFLATABLE PENILE PROSTHESIS (IPP) DID NOT INFLATE. A SURGICAL PROCEDURE WAS PERFORMED, DURING WHICH A DEFECT IN THE TUBING BETWEEN THE PUMP AND CYLINDERS WAS IDENTIFIED; THEREFORE, THE EXISTING IPP WAS REMOVED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21232534 ↗
• InjuryJan 10, 2025Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) HAD INFLATION ISSUES. THE PUMP WAS SQUEEZED, BUT THE CYLINDERS DO NOT INFLATE. THE DEVICE WAS EXPLANTED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21125887 ↗
• InjuryDec 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A SURGICAL PROCEDURE INVOLVING AN INFLATABLE PENILE PROSTHESIS (IPP) DUE TO SUSPECTED INFECTION THAT CAUSED THE PUMP TO BECOME ADHERED TO THE SCROTUM. ALL COMPONENTS WERE REMOVED AND REPLACED WITHOUT REPORTED COMPLICATIONS.

  Patient problems: Adhesion(s); Unspecified Infection

  MAUDE report 20857577 ↗
• InjuryDec 3, 2024Mechanical Problem; Material Puncture/Hole; Mechanical Problem; Material Puncture/Hole

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) WAS NOT WORKING BECAUSE THERE WAS A TEAR IN BOTH CYLINDERS, THE OUTER LAYER OF SILICONE WAS TORN ON BOTH CYLINDERS. THE IPP WAS EXPLANTED AND REPLACED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20831829 ↗
• InjuryOct 25, 2024Mechanical Problem; Adverse Event Without Identified Device or Use Problem; Mechanical Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PUMP OF THIS INFLATABLE PENILE PROSTHESIS (IPP) WOULD NOT REFILL ONCE COMPRESSED. THE IPP WAS EXPLANTED AND REPLACED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20532339 ↗