AMS 700 CXR MS Pump 72404262Recalls & reported problems

Summary

The FDA's MAUDE database contains 51 adverse event reports that list this exact device (DI 00878953003702), received between Dec 17, 2018 and Sep 28, 2026 — classified as 47 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Inflation Problem” (18 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 51 reports, in the reporter's own words as published by the FDA.

• InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Erythema; Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 50915304 ↗
• InjuryJul 20, 2026Fluid/Blood Leak; Mechanical 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 IT WAS IDENTIFIED THAT THE TUBING HAD FRACTURED ABOVE THE PUMP CAUSING FLUID LOSS. THE CYLINDERS AND PUMP WERE REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25876904 ↗
• InjuryJun 29, 2026Inflation Problem; Mechanical Problem

  IT WAS REPORTED THAT THE PATIENT'S INFLATABLE PENILE PROSTHESIS (IPP) EXPERIENCED INFLATION DIFFICULTIES DURING PUMPING. A SURGICAL INTERVENTION WAS PERFORMED, DURING WHICH A SURROGATE RESERVOIR TEST WAS CONDUCTED. BACK PRESSURE WAS OBSERVED IN THE SURROGATE SYRINGE DURING PUMPING, WITH NO FLUID TRANSFER THROUGH THE PUMP, INDICATING A SUSPECTED PUMP ISSUE. THE PUMP WAS RESET; HOWEVER, NO IMPROVEMENT WAS NOTED. THE RESERVOIR WAS INSPECTED AND CONFIRMED TO STILL CONTAIN FLUID. THE CYLINDERS AND REAR TIP EXTENDERS (RTES) WERE EXPLANTED. NEW CX CYLINDERS AND RTES WERE IMPLANTED AND CONNECTED TO THE EXISTING RESERVOIR. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25661237 ↗
• InjuryApr 7, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE POSTOPERATIVE PERIOD FOLLOWING THE IMPLANTATION OF AN INFLATABLE PENILE PROSTHESIS (IPP), THE PATIENT DEVELOPED A HEMATOMA AROUND THE SCROTAL WOUND. HE WAS TREATED WITH ANTIBIOTICS, WHICH RESULTED IN CLINICAL IMPROVEMENT. HOWEVER, DURING SUBSEQUENT FOLLOW UP, THE DEVICE COULD NOT BE ACTIVATED, AS THE PATIENT EXPERIENCED PAIN WHEN ATTEMPTING TO OPERATE THE PUMP. UPON EVALUATION, EXTRUSION OF THE CONNECTION TUBING WAS OBSERVED. IT WAS MENTIONED THAT THE PROBABLE CAUSE, WAS THE HEMATOMA DEVELOPED DURING THE LATE POSTOPERATIVE PERIOD. CONSEQUENTLY, THE PATIENT WAS HOSPITALIZED TO SCHEDULE AN EXPLANT SURGICAL PROCEDURE.

  Patient problems: Erosion; Hematoma; Pain

  MAUDE report 24802245 ↗
• InjuryJan 16, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WITH THIS INFLATABLE PENILE PROSTHESIS (IPP) PRESENTED WITH INFECTION, PAIN, AND SWELLING. THE AREA APPEARED RED AND FELT HOT TO THE TOUCH. THE IPP WAS EXPLANTED. THERE IS NO ADDITIONAL INFORMATION REPORTED.

  Patient problems: Erythema; Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 24094534 ↗
• InjuryJan 14, 2026Fluid/Blood Leak; Inflation Problem; Mechanical Problem; Material Puncture/Hole

  IT WAS REPORTED THAT THE PATIENT'S INFLATABLE PENILE PROSTHESIS (IPP) WAS NO LONGER FUNCTIONING AND EXHIBITED INFLATION ISSUES. A SURGICAL PROCEDURE WAS PERFORMED, DURING WHICH A FLUID LEAK WAS IDENTIFIED, CAUSED BY A BROKEN CYLINDER TUBE AT ITS CONNECTION TO THE PUMP. THE IPP WAS SUCCESSFULLY REPLACED, AND NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24072750 ↗
• MalfunctionNov 27, 2025Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT, DURING PRE-IMPLANT TESTING OF THIS INFLATABLE PENILE PROSTHESIS (IPP), THE DEVICE WAS INFLATED BUT IT WOULD NOT DEFLATE; THEREFORE, A DIFFERENT SET OF CYLINDERS AND PUMP WERE USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23667610 ↗
• InjuryMar 14, 2025Collapse; Fluid/Blood Leak; Inflation Problem; Air/Gas in Device; Collapse; Fluid/Blood Leak; Inflation Problem; Air/Gas in Device

  IT WAS REPORTED THAT THE PUMP OF THIS INFLATABLE PENILE PROSTHESIS (IPP) WAS SUCKING FLAT AND HAD FLUID LOSS. AIR WAS NOTICED ON THE PUMP. THE IPP WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21608214 ↗
• InjuryFeb 24, 2025Fluid/Blood Leak; Mechanical Problem; Defective Device; Fluid/Blood Leak; Mechanical Problem; Defective Device

  IT WAS REPORTED THAT THE INFLATABLE PENILE PROSTHESIS (IPP) VALVE COLLAPSED, IT WAS NOT WORKING, AND THE RIGHT CYLINDER IS APPARENTLY BROKEN. THE RESERVOIR IS EMPTY. DUE TO THIS, A SURGICAL PROCEDURE WAS SCHEDULED. THE PATIENT OUTCOME IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21449725 ↗
• InjuryFeb 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) EXPERIENCED MILD SCROTAL BRUISING AND SCROTAL EDEMA. NO ADDITIONAL INFORMATION WAS REPORTED.

  Patient problems: Hematoma; Swelling/ Edema

  MAUDE report 21410484 ↗
• InjuryJan 16, 2025Inadequacy of Device Shape and/or Size; Malposition of Device; Inadequacy of Device Shape and/or Size; Malposition of Device

  IT WAS REPORTED THAT THE PATIENT WITH THIS INFLATABLE PENILE PROSTHESIS (IPP) PRESENTED WITH A CYLINDER THAT SEEMED TOO LONG OR NOT SEATED WELL WHICH POTENTIALLY WAS IMPENDING EROSION. UPON REVISION, AN INFECTION WAS IDENTIFIED; THEREFORE, THE EXISTING IPP WAS REMOVED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Erosion; Unspecified Infection

  MAUDE report 21170046 ↗
• InjuryJan 8, 2025Inflation Problem; Mechanical Problem; Migration; Inflation Problem; Mechanical Problem; Migration

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) HAD A LACK OF RIGIDITY ON THE RIGHT SIDE UPON FULL INFLATION. UPON REVISION, THE RIGHT CYLINDER WAS CROSSED OVER TO THE LEFT CORPORA BODY. THIS ISSUE PREVENTED FULL INFLATION AND RIGIDITY. THE CYLINDERS AND PUMP WERE REMOVED AND REPLACED. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21101338 ↗
• InjuryOct 30, 2024Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE PATIENT WITH THIS INFLATABLE PENILE PROSTHESIS (IPP) EXPERIENCED AUTO-INFLATION. A SURGICAL PROCEDURE WAS PERFORMED IN WHICH ALL COMPONENTS WERE REMOVED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20570274 ↗
• InjurySep 21, 2024Fluid/Blood Leak; Inflation Problem; Fluid/Blood Leak; Inflation Problem

  IT WAS REPORTED THAT A PATIENT WITH THIS INFLATABLE PENILE PROTHESIS (IPP) EXPERIENCED INFLATION ISSUES. UPON REMOVAL OF THE IPP IT WAS DETERMINED THAT THERE WAS NO FLUID IN THE RESERVOIR. A REPLACEMENT SURGERY WAS PERFORMED IN WHICH A NEW IPP WAS IMPLANTED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20275428 ↗
• InjuryJul 2, 2024Collapse; Fluid/Blood Leak; Inflation Problem; Collapse; Fluid/Blood Leak; Inflation Problem

  IT WAS REPORTED THAT THE CYLINDERS OF THIS INFLATABLE PENILE PROSTHESIS (IPP) WERE NOT INFLATING AS EXPECTED DUE TO FLUID LOSS IN THE RESERVOIR. IT WAS ALSO NOTED THAT THE PUMP REMAINED STUCK IN THE DEPRESSED POSITION. THE RESERVOIR WAS EXPLANTED AND REPLACED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19652907 ↗
• InjuryMay 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INFLATABLE PENILE PROSTHESIS (IPP) REVISION BECAUSE THE PATIENT FELL, AND THE IMPLANT INCISION RE-OPENED. THERE WERE NO DEVICE ISSUES. THERE WERE NO ADDITIONAL PATIENT COMPLICATIONS.

  Patient problems: Wound Dehiscence

  MAUDE report 19322706 ↗
• InjuryMay 30, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INFLATABLE PENILE PROSTHESIS (IPP) REPLACEMENT SURGERY DUE TO CYLINDER EROSION. NO ADDITIONAL INFORMATION WAS REPORTED.

  Patient problems: Erosion

  MAUDE report 17020227 ↗
• InjuryMay 9, 2023Inflation Problem; Inflation Problem

  THE PATIENT UNDERWENT AN AMS INFLATABLE PENILE PROSTHESIS (IPP) REVISION SURGERY DUE TO THE DEVICE NOT INFLATING AS WELL AS IT HAD BEEN. THE PATIENT EXPERIENCED DIFFICULTY WITH THE PUMP. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16895424 ↗
• InjuryMay 8, 2023Migration; Migration

  IT WAS REPORTED THAT THE PATIENT UNDERWENT INFLATABLE PENILE PROSTHESIS (IPP) REPLACEMENT SURGERY TO REPLACE IPP WITH TACTRA AS THERE WAS A SMALL BUMP COMING OUT THE RIGHT SIDE OF THE GLANDS. THE PATIENT EXPERIENCED EXTRUSION DUE TO MIGRATION OF RIGHT CYLINDER. A TACTRA DEVICE WAS IMPLANTED IN A BETTER POSITION TO NOT CAUSE THE BUMP ANYMORE. THE PATIENT OUTCOME WAS REPORTED TO BE FULLY RECOVERED.

  Patient problems: Erosion

  MAUDE report 16890430 ↗
• InjuryApr 20, 2023Collapse; Mechanical Problem; Collapse; Mechanical Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INFLATABLE PENILE PROSTHESIS (IPP) REVISION SURGERY BECAUSE THE DEVICE STOPPED WORKING AND THE PUMP WAS STAYING FLAT. TROUBLESHOOTING WAS ATTEMPTED TO NO AVAIL; THEREFORE, THE CYLINDERS AND PUMP WERE REMOVED AND REPLACED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16777433 ↗
• InjuryMar 7, 2023Malposition of Device; Malposition of Device

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A MALPOSITION OF THE CYLINDERS WITH THIS INFLATABLE PENILE PROSTHESIS (IPP), AS THE RIGHT CYLINDER EXTRUDED FROM THE CORPUS CAVERNOSUM. THE DEVICE WAS REMOVED AND REPLACED WITH A TACTRA DEVICE. THERE WERE NO ADDITIONAL PATIENT COMPLICATIONS REPORTED.

  Patient problems: Erosion

  MAUDE report 16500439 ↗
• InjuryFeb 22, 2023Collapse; Material Puncture/Hole; Collapse; Material Puncture/Hole

  IT WAS REPORTED THAT THE PATIENT STATED THAT THE INFLATABLE PENILE PROSTHESIS (IPP) PUMP BULB WENT FLAT WHEN PUMPING. THE PATIENT DISCUSSED VALVE RESET AND TROUBLESHOOTING TECHNIQUES WITH BOSTON SCIENTIFIC PATIENT SERVICES SPECIALIST. THE PATIENT UNDERWENT SURGERY AND ALL COMPONENTS WERE REMOVED AND REPLACED. BOTH CYLINDERS HAD A HOLE IN IT. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16423106 ↗
• InjuryDec 20, 2022Mechanical Problem; Adverse Event Without Identified Device or Use Problem; Mechanical Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A SURGICAL PROCEDURE TO EXPLANT THIS INFLATABLE PENILE PROSTHESIS (IPP) DUE TO THE LEFT CYLINDER PUSHING LATERALLY ON THE SKIN IN ADDITION TO PAIN IN THE GLANS AT THE CYLINDER TIP. THE EXISTING DEVICE WAS REMOVED AND REPLACED WITH A NEW IPP. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Pain

  MAUDE report 16016928 ↗
• InjurySep 14, 2022Fluid/Blood Leak; Inflation Problem; Material Puncture/Hole; Fluid/Blood Leak; Inflation Problem; Material Puncture/Hole

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED INFLATION ISSUES WITH AN INFLATABLE PENILE PROSTHESIS (IPP) LEADING TO A REVISION SURGERY. DURING THE PROCEDURE, FLUID LOSS WAS NOTED DUE TO A TEAR IN THE LEFT CYLINDER. THE EXISTING CYLINDER AND PUMP WERE REMOVED AND REPLACED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15421864 ↗
• InjuryAug 29, 2022Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INFLATABLE PENILE PROSTHESIS (IPP) REPLACEMENT SURGERY BECAUSE THE CYLINDERS WERE TOO SHORT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15316786 ↗