AMS 700 CXR MS Pump 72404268Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 00878953003764), received between Jun 7, 2019 and Oct 16, 2024 — classified as 17 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Inflation Problem” (9 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• InjuryOct 16, 2024Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT THE PATIENT WANTED MORE GIRTH WITH A CX INFLATABLE PENILE PROSTHESIS (IPP) INSTEAD OF HIS CXR IPP. THE PATIENT UNDERWENT SURGERY TO REPLACE THE DEVICE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20462023 ↗
• MalfunctionSep 16, 2024Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE PATIENT STATED HIS INFLATABLE PENILE PROSTHESIS IS NOT PERFORMING AS EXPECTED. THE PATIENT WAS EVALUATED BY A PHYSICIAN, WHO CONFIRMED THAT THE DEVICE NEEDS TO BE REPLACED. THE PATIENT WAS SCHEDULED FOR A REVISION SURGERY ON 25SEP2024. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20226353 ↗
• InjuryAug 12, 2024Fluid/Blood Leak; Inflation Problem; Fluid/Blood Leak; Inflation Problem

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) WAS NO LONGER INFLATING DUE TO FLUID LOSS FROM THE RESERVOIR. A SURGICAL PROCEDURE WAS PERFORMED TO REMOVE AND REPLACE THE DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19966791 ↗
• InjuryJun 26, 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) WAS NOT WORKING PROPERLY; THEREFORE, A REVISION SURGERY WAS PERFORMED TO REMOVE AND REPLACE CYLINDERS AND PUMP. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19613733 ↗
• InjuryFeb 7, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH AN INFLATABLE PENILE PROSTHESIS (IPP) THAT HAD A FLUID LEAK. SURGICAL INTERVENTION WAS PERFORMED TO EXPLANT THE IPP AND REPLACE WITH A NEW IPP. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18664937 ↗
• InjuryJan 29, 2024Inflation Problem; Mechanical Problem; Inflation Problem; Mechanical Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH AN INFLATABLE PENILE PROSTHESIS (IPP) THAT WAS AUTO INFLATING. THE PHYSICIAN EVALUATED THE PATIENT AND DETERMINED THERE WAS TOO MUCH PRESSURE SURROUNDING THE RESERVOIR. SURGICAL INTERVENTION WAS PERFORMED TO EXPLANT THE IPP AND REPLACE WITH A NEW IPP. THERE WERE NO ADDITIONAL PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18603191 ↗
• InjuryNov 6, 2023Material 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 THIS INFLATABLE PENILE PROSTHESIS (IPP) HAD TO BE EXPLANTED DUE TO A HOLE IN THE LEFT CYLINDER. THE DEVICE WAS REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18075781 ↗
• InjuryOct 10, 2023Fluid/Blood Leak; Inflation Problem; Fluid/Blood Leak; Inflation Problem

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS WAS REMOVED AS IT WOULD NOT INFLATE DUE TO AN UNKNOWN FLUID LEAK. A NEW INFLATABLE PENILE PROSTHESIS WAS IMPLANTED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17908448 ↗
• MalfunctionSep 22, 2023Inflation Problem; Material Puncture/Hole; Adverse Event Without Identified Device or Use Problem; Inflation Problem; Material Puncture/Hole; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT VISITED THE HOSPITAL BECAUSE HIS INFLATABLE PENILE PROSTHESIS WAS NOT INFLATING, A CYLINDER WAS PERFORATED. THE PATIENT UNDERWENT SURGERY A MONTH LATER, ALL COMPONENTS WERE REMOVED AND REPLACED. THE SPECIFIC DEVICE PROBLEM COULD NOT BE IDENTIFIED. THERE WERE NO REPORTED PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17798321 ↗
• InjuryMay 19, 2023Fluid/Blood Leak; Adverse Event Without Identified Device or Use Problem; Fluid/Blood Leak; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INFLATABLE PENILE PROSTHESIS (IPP) REPLACEMENT SURGERY DUE TO A TOTAL FLUID LOSS FROM THE SYSTEM. IT WAS DETAILED THAT THE FLUID LOSS WAS IDENTIFIED BECAUSE THE DEVICE DID NOT INFLATE ANYMORE. THE LOCATION AND SOURCE OF THE FLUID LOSS IS SUSPECTED TO BE A CONNECTION. ALL COMPONENTS WERE REMOVED AND REPLACED WITH NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16964711 ↗
• InjuryApr 19, 2023Inadequacy of Device Shape and/or Size; Malposition of Device; Inadequacy of Device Shape and/or Size; Malposition of Device

  IT WAS REPORTED THAT, ALTHOUGH THE PUMP OF THIS INFLATABLE PENILE PROSTHESIS PUMP WAS STILL FUNCTIONAL, IT WAS SLIGHTLY STICKY, PLACED TOO HIGH IN THE SCROTUM, AND UNDERSIZED. THE PUMP AND CYLINDERS WERE EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16768868 ↗
• InjuryFeb 9, 2022Collapse; Mechanical Problem; Difficult or Delayed Activation; Adverse Event Without Identified Device or Use Problem; Collapse; Mechanical Problem; Difficult or Delayed Activation; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) EXHIBITED ACTIVATION ISSUES WHICH WERE NOTED APPROXIMATELY TWO MONTHS AFTER IMPLANT AT A FOLLOW-UP APPOINTMENT. OUR RECORDS INDICATE THAT NO REVISION SURGERY OR SURGICAL EVALUATION HAS BEEN PERFORMED TO DATE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13503028 ↗
• InjuryAug 24, 2021Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INFLATABLE PENILE PROSTHESIS (IPP) REVISION SURGERY. ALL COMPONENTS WERE REMOVED AND A HOLE WAS NOTED IN ONE OF THE CYLINDERS. A NEW IPP WAS IMPLANTED. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE PATIENT OUTCOME TO DATE, DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12362996 ↗
• InjuryJul 21, 2021Deflation Problem; Inflation Problem; Malposition of Device; Deflation Problem; Inflation Problem; Malposition of Device

  IT WAS REPORTED THAT THE PATIENT HAD A SURGICAL PROCEDURE TO REPLACE AN INFLATABLE PENILE PROSTHESIS (IPP) DUE TO PAIN, MALPOSITION, INFLATION AND DEFLATION ISSUES. AT THE TIME OF THE REVISION, IT WAS DISCOVERED THAT THE CYLINDERS WERE CROSSED OVER. NO PATIENT CLINICAL COMPLICATIONS WERE REPORTED.

  Patient problems: Pain

  MAUDE report 12205620 ↗
• InjuryMay 18, 2021Malposition of Device; Malposition of Device

  IT WAS REPORTED THAT THE PATIENT HAD A SURGICAL PROCEDURE TO REVISE AN INFLATABLE PENILE PROSTHESIS (IPP) DUE TO MALPOSITION OF THE PUMP. THE PATIENT WANTED BETTER ACCESS TO THE PUMP. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11842584 ↗
• InjuryMay 5, 2021Inflation Problem; Mechanical Problem; Inflation Problem; Mechanical Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED INFLATION ISSUES WITH AN INFLATABLE PENILE PROSTHESIS (IPP). IT WAS INDICATED THAT THE PHYSICIAN ALSO ATTEMPTED TO CYCLE THE DEVICE TO NO AVAIL. A SURGICAL PROCEDURE WAS PERFORMED IN WHICH THE PUMP WAS REMOVED AND REPLACED. THERE WERE NO PATIENT COMPLICATIONS RELATED TO THE EVENT AND THE PATIENT WAS EXPECTED TO FULLY RECOVER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11778644 ↗
• InjuryApr 29, 2021Degraded; Inflation Problem; Mechanical Problem; Defective Device; Degraded; Inflation Problem; Mechanical Problem; Defective Device

  IT WAS REPORTED THAT THE INFLATABLE PENILE PROSTHESIS (IPP) DEVICE HAD PERFORMANCE ISSUES FOUR YEARS AFTER IMPLANT. IT HAD INFLATION ISSUES AND THE PUMP WAS NOT OPERATING AS EXPECTED. ALL COMPONENTS WERE EXPLANTED WITHOUT PATIENT COMPLICATIONS. UPON EXPLANT, IT WAS IDENTIFIED THAT THE REASON FOR THE DEVICE NOT FUNCTIONING, AS AN ANEURYSM AT THE RIGHT CYLINDER. THE PUMP AND CYLINDERS WERE EXPLANTED AND REPLACED. THE RESERVOIR REMAINS IN SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11746469 ↗
• MalfunctionApr 27, 2021Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE PATIENT WAS UNABLE TO SQUEEZE THE PUMP IN ORDER TO FILL THE CYLINDERS. THE PHYSICIAN BROUGHT THE PATIENT IN FOR CONSULTATION AND TO ACTIVATE THE IMPLANT, BUT HAD DIFFICULTY INFLATING THE CYLINDERS. THE PUMP BULB WAS HARD TO SQUEEZE AND NOT OPERATING AS EXPECTED. THE ISSUE WAS UNABLE TO BE RESOLVED SO THE PATIENT WILL HAVE A REVISION SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11734422 ↗
• InjuryApr 27, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT HAD AN INFLATABLE PENILE PROSTHESIS (IPP) IMPLANTED ON (B)(6) 2019. AN INFECTION AT THE SCROTUM AND PENIS WAS IDENTIFIED. THE DEVICE WAS EXPLANTED AND REPLACED. THE PATIENT IS EXPECTED TO FULLY RECOVER.

  Patient problems: Unspecified Infection

  MAUDE report 11733895 ↗
• MalfunctionDec 29, 2020Inflation Problem; Mechanical Problem; Inflation Problem; Mechanical Problem

  IT WAS REPORTED THAT INFLATABLE PENILE PROSTHESIS (IPP) PUMP MALFUNCTIONED SIX MONTHS AFTER IMPLANT. THE DEVICE WAS IMPOSSIBLE TO INFLATE. PATIENT UNDERWENT A SURGICAL PROCEDURE TO EXPLANT HIS IPP DEVICE. ALL COMPONENTS WERE EXPLANTED AND REPLACED.

  Patient problems: Insufficient Information; No Known Impact Or Consequence To Patient

  MAUDE report 11089998 ↗
• InjuryJun 7, 2019Adverse Event Without Identified Device or Use Problem; Migration; Adverse Event Without Identified Device or Use Problem; Migration

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN EXTRUSION OF INFLATABLE PENILE PROSTHESIS(IPP) CYLINDER DUE TO THE EXTRUSION OF THE CYLINDER BY THE URETHRAL MEATUS. THE PATIENT COULD STILL URINATE WITHOUT DIFFICULTY AND WILL BE SCHEDULED FOR AN EXPLANATION OF THE PROSTHESIS. A STABLE PATIENT CONDITION WAS REPORTED.

  Patient problems: Erosion; Incontinence; No Consequences Or Impact To Patient

  MAUDE report 8679190 ↗