AMS 700 CXR MS Pump 72404261Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 00878953003696), received between Mar 21, 2019 and Dec 22, 2025 — classified as 20 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (12 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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• InjuryDec 22, 2025Fluid/Blood Leak; Mechanical Problem; Fluid/Blood Leak; 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 CONFIRMED THAT, UPON REMOVAL OF THE PREVIOUS PUMP, THERE WAS NO FLUID PRESENT IN THE SYSTEM AND PHYSICIAN STATED THAT THE SUSPECTED CAUSE OF THE FLUID LOSS WAS ATTRIBUTED TO THE AGE OF THE DEVICE. THE DEVICE WAS EXPLANTED AND REPLACED. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23873251 ↗
• InjuryOct 23, 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 AN INFECTION. A SURGICAL PROCEDURE WAS PERFORMED IN WHICH THE DEVICE WAS REMOVED. THERE WERE NO FURTHER PATIENT COMPLICATIONS REPORTED.

  Patient problems: Unspecified Infection

  MAUDE report 23368841 ↗
• InjurySep 3, 2025Mechanical Problem; Migration; Mechanical Problem; Migration

  IT WAS REPORTED THAT THE PATIENT WITH THIS INFLATABLE PENILE PROSTHESIS (IPP) EXPERIENCED SLIGHT DISCOMFORT, AND THE PRODUCT NO LONGER PUMPED ALL THE WAY UP. SURGICAL EVALUATION DETERMINED THAT THE DISTAL TIP WAS POSITIONED MID-CORPORA AND NOT SEATED IN THE GLANS. A SURGICAL PROCEDURE WAS PERFORMED IN WHICH THE DEVICE WAS REMOVED AND REPLACED. THERE WERE NO FURTHER PATIENT COMPLICATIONS REPORTED.

  Patient problems: Discomfort

  MAUDE report 22952327 ↗
• InjuryJul 2, 2025Fluid/Blood Leak; Mechanical Problem; Fluid/Blood Leak; Mechanical Problem

  IT WAS REPORTED THAT THE INFLATABLE PENILE PROSTHESIS (IPP) STOPPED WORKING, AND THE PUMP NO LONGER FUNCTIONED. UPON REVISION, A FLUID LOSS WAS IDENTIFIED; HOWEVER, THE MEDICAL STAFF WAS UNABLE TO LOCATE THE SOURCE. CONSEQUENTLY, THE IPP WAS REMOVED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22391514 ↗
• InjuryJan 10, 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 WITH PROXIMAL PERFORATION, THE SURGEON CLOSED IT PERINEALLY. IT WAS REPORTED THAT THE ORIGINAL SURGERY REQUIRED THREE HOURS TO DILATE, THE PERFORATION COULD HAVE CONTRIBUTED TO THE PERFORATION. THE IPP WAS EXPLANTED. THERE IS NO ADDITIONAL INFORMATION REPORTED.

  Patient problems: Perforation

  MAUDE report 21125855 ↗
• InjuryOct 21, 2024Fluid/Blood Leak; Mechanical Problem; Adverse Event Without Identified Device or Use Problem; Fluid/Blood Leak; Mechanical Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CYLINDER OF THIS INFLATABLE PENILE PROSTHESIS (IPP) EXHIBITED FLUID LOSS. IT WAS NOTED THAT THE DEVICE DID NOT WORK ANYMORE AND WAS EMPTY. THE EXISTING DEVICE WAS EXPLANTED AND REPLACED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20493856 ↗
• InjuryDec 7, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT WITH THIS INFLATABLE PENILE PROSTHESIS (IPP) EXPERIENCED SCARRING. THE PATIENT WAS REPORTED TO HAVE ONLY THE RIGHT CYLINDER IMPLANTED. A REVISION SURGERY WAS PERFORMED TO EXPLANT AND REPLACE ONLY THE RIGHT CYLINDER OF THE DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Scar Tissue

  MAUDE report 18288765 ↗
• InjuryFeb 27, 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 THE PATIENT WENT TO OFFICE CONSULTATION BECAUSE THE DEVICE WAS NOT WORKING PROPERLY. TWO WEEKS LATER, A SURGICAL PROCEDURE WAS PERFORMED AND A TEAR IN THE CYLINDER WAS NOTED. THE CYLINDER AND PUMP WERE REMOVED AND REPLACED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16449458 ↗
• InjuryDec 13, 2022Adverse 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 TO THE HOSPITAL WITH PAIN IN THEIR PENIS. SIGNS OF INFECTION, INCLUDING A SWOLLEN SCROTUM WITH PURULENT DISCHARGE, WERE PRESENT. SURGERY WAS PERFORMED, DURING WHICH URETHRAL EROSION WAS CONFIRMED. THE ENTIRE DEVICE WAS REMOVED TO ALLOW THE PATIENT TO HEAL. THE TYPE OF INFECTION WAS NOT DETERMINED. THE PATIENT WAS TREATED WITH ANTIBIOTICS. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Erosion; Purulent Discharge; Unspecified Infection

  MAUDE report 15966790 ↗
• InjuryOct 12, 2022Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THE PATIENT HEARD A SOUND LIKE SOMETHING HAD BROKEN IN HIS INFLATABLE PENILE PROSTHESIS (IPP). AFTER THAT, THE IPP DID NOT PERFORM AS EXPECTED AND THE PATIENT EXPERIENCED PAIN. A SURGERY WAS PERFORMED AND A HOLE WAS OBSERVED IN THE RIGHT CYLINDER; THEREFORE, THIS CYLINDER WAS REPLACED. THERE WERE NO FURTHER PATIENT COMPLICATIONS.

  Patient problems: Pain

  MAUDE report 15592183 ↗
• InjuryAug 4, 2022Inflation Problem; Material Puncture/Hole; Inflation Problem; Material Puncture/Hole

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A SURGICAL PROCEDURE TO REMOVE THIS INFLATABLE PENILE PROSTHESIS (IPP) DUE TO INABILITY TO INFLATE THE IMPLANT. DURING THE PROCEDURE, IT WAS DETERMINED THAT THERE WAS A HOLE IN ONE OF THE CYLINDERS. THE EXISTING DEVICE WAS EXPLANTED AND REPLACED WITH A NEW IPP. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15169988 ↗
• InjuryApr 29, 2022Collapse; Inflation Problem; Defective Device; Collapse; Inflation Problem; Defective Device

  IT WAS REPORTED THAT THE PATIENT WITH THIS INFLATABLE PENILE PROSTHESIS COMPLAINED OF INFLATION ISSUES AS THE IMPLANT DID NOT GET TO THE TIP OF THEIR GLANS AND HAD DIFFICULTIES ACTIVATING THE PUMP, WHICH LED TO AN IN-CLINIC EVALUATION. PUMP TROUBLESHOOTING WAS PERFORMED; HOWEVER, PERFORMANCE ISSUES WERE NOT RESOLVED. IT WAS DECIDED TO REMOVE AND REPLACE THE PUMP AND CYLINDERS, THE NEW COMPONENTS WERE CONNECTED TO THE EXISTING RESERVOIR. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14256017 ↗
• MalfunctionOct 15, 2021Inflation Problem; Adverse Event Without Identified Device or Use Problem; Inflation Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WITH THIS INFLATABLE PENILE PROSTHESIS (IPP) REQUESTED A REVISION DUE TO INABILITY TO COMPLETELY INFLATE THE IPP. THE DEVICE WAS EXPLANTED AND RETURNED FOR ANALYSIS; NO INFORMATION WAS PROVIDED REGARDING DEVICE REPLACEMENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12642946 ↗
• InjuryOct 15, 2021Fluid/Blood Leak; Mechanical Problem; Material Puncture/Hole; Fluid/Blood Leak; Mechanical Problem; Material Puncture/Hole

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING ISSUES WITH AN INFLATABLE PENILE PROSTHESIS (IPP). DURING FOLLOW-UP IN OFFICE, THE PHYSICIAN TRIED TO PUMP THE IMPLANT AND THE DEVICE DID NOT WORK; FLUID LOSS WAS SUSPECTED AND A SURGERY WAS SCHEDULED. DURING SURGERY, THE PUMP HAD JUST A SMALL AMOUNT OF FLUID. THE SOURCE OF THE FLUID LOSS WAS A TEAR IN THE RIGHT CYLINDER AND IT WAS SAID THAT THERE WAS A HOLE SOMEWHERE. THE DEVICE WAS REMOVED AND REPLACED WITH A TACTRA DEVICE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12639093 ↗
• InjurySep 13, 2021Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A SURGICAL PROCEDURE TO EXPLANT THIS INFLATABLE PENILE PROSTHESIS (IPP) BECAUSE THE DEVICE NO LONGER WAS SUFFICIENT AT PROVIDING AT AN ARTIFICIAL ERECTION. ALL COMPONENTS OF THE EXISTING IPP WERE EXPLANTED AND REPLACED WITH A NEW IPP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12460796 ↗
• InjuryAug 24, 2021Fluid/Blood Leak; Mechanical Problem; Fluid/Blood Leak; Mechanical Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A SURGICAL PROCEDURE TO REVISE THIS INFLATABLE PENILE PROSTHESIS (IPP) DUE TO THE DEVICE NOT CYCLING AND DEVICE MALFUNCTIONING AS A RESULT OF FLUID LOSS. THE IPP WAS EXPLANTED AND REPLACED WITH A NEW IPP WITH NO CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12359900 ↗
• MalfunctionJul 23, 2021Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE PHYSICIAN FELT AS IF THE INFLATABLE PENILE PROSTHESIS WAS CYCLING UNUSUALLY AND WAS NOT WORKING PROPERLY. THE PHYSICIAN PLANS ON REPLACING THE DEVICE AT A LATER UNKNOWN DATE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12216618 ↗
• InjuryJun 16, 2021Fluid/Blood Leak; Mechanical Problem; Material Puncture/Hole; Fluid/Blood Leak; Mechanical Problem; Material Puncture/Hole

  IT WAS REPORTED THAT PATIENT CAME TO THE HOSPITAL, THE PHYSICIAN TRIED TO CYCLE THE INFLATABLE PENILE PROSTHESIS (IPP) AND FELT A FLUID LEAK IN THE DEVICE. A REPLACEMENT SURGERY WAS PERFORMED AND TWO BREAKS WERE OBSERVED IN THE TUBE CONNECTING THE LEFT CYLINDER AND PUMP. ALL COMPONENTS WERE REMOVED AND REPLACED. THERE WERE NO PATIENT COMPLICATIONS IN RELATION TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12009956 ↗
• InjuryDec 30, 2020Deflation Problem; Inflation Problem; Mechanical Problem; Deflation Problem; Inflation Problem; Mechanical Problem

  IT WAS REPORTED THAT THE PATIENT SAID HE COULD NOT INFLATE OR DEFLATE HIS INFLATABLE PENILE PROSTHESIS (IPP) DEVICE. ONCE IN SURGERY THE PUMP WAS ACCESSED AND THE DEVICE FUNCTIONED NORMALLY. IT WAS ABLE TO INFLATE AND DEFLATE WITH NO ISSUES. THE PUMP AND CYLINDERS WERE REMOVED AND REPLACED WITH 11MM TACTRA.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 11096054 ↗
• InjuryMar 24, 2020Fluid/Blood Leak; Mechanical Problem; Material Puncture/Hole; Fluid/Blood Leak; Mechanical Problem; Material Puncture/Hole

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION PROCEDURE DUE TO THE DEVICE MALFUNCTIONING RESULTING FROM A SMALL HOLE IN THE RESERVOIR TUBING CAUSING FLUID LOSS WITH AN INFLATABLE PENILE PROSTHESIS (IPP). THE IPP CYLINDER, PUMP, AND RESERVOIR WAS EXPLANTED AND A NEW IPP CYLINDER, PUMP, AND RESERVOIR WAS IMPLANTED. DURING THE TIME OF REVISION THE HOLE WAS IDENTIFIED. THE PATIENT RECOVERED FOLLOWING THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9873942 ↗
• InjuryMay 23, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT WANTED ANOTHER AMS 800 ARTIFICIAL URINARY SPHINCTER (AUS) FOR BETTER CONTINENCE. THE PHYSICIAN TOLD HIM THAT WOULD ONLY BE POSSIBLE USING A TRANSCROTAL CUFF PLACEMENT, WHICH COULD NOT BE DONE WITH THE EXISTING AMS 700 INFLATABLE PENILE PROSTHESIS (IPP). THE PATIENT OPTED TO HAVE THE ENTIRE FULLY FUNCTIONING IPP SYSTEM REMOVED AND REPLACED WITH A NEW AUS. NO FURTHER COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8637451 ↗
• InjuryMar 21, 2019Migration; Migration

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INFLATABLE PENILE PROSTHESIS (IPP) REPLACEMENT SURGERY BECAUSE HE WAS DISSATISFIED THAT THE CYLINDERS WERE NO LONGER IN THE MID GLANS. THE PENIS WAS FLOPPY, AND APPEARED UNDERSIZED AS A RESULT. THE PATIENT ALSO COMPLAINED OF POOR RIGIDITY FROM THE IPP. NO PATIENT COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT. THE PATIENT WAS REPORTED TO BE RECOVERING AFTER THE PROCEDURE. THE EXPLANTED IPP WAS NOT RETURNED FOR INVESTIGATION.

  Patient problems: Therapeutic Effects, Unexpected

  MAUDE report 8441632 ↗