AMS 700 CX MS Pump 72404283Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00878953003863), received between Oct 14, 2019 and Jan 13, 2026 — classified as 16 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Inflation Problem” (8 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• InjuryJan 13, 2026Deflation Problem

  IT WAS REPORTED THAT THE PATIENT'S INFLATABLE PENILE PROSTHESIS (IPP) EXPERIENCED PROLONGED DEFLATION ISSUES, CAUSING PAIN AND DISCOMFORT. THE PHYSICIAN CONDUCTED A PHYSICAL EXAMINATION AND ATTEMPTED STANDARD DEFLATION STEPS, CONFIRMING THAT THE PROSTHESIS DID NOT FULLY DEFLATE; ONLY ABOUT 30% DEFLATION WAS ACHIEVED. THIS PARTIAL DEFLATION PROVIDED TEMPORARY PAIN RELIEF. A REVISION SURGERY WILL BE REQUIRED BUT HAS NOT YET BEEN SCHEDULED OR PERFORMED. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Discomfort; Pain

  MAUDE report 24056098 ↗
• InjuryDec 19, 2025Collapse; Fluid/Blood Leak; Inflation Problem; Mechanical Problem; Nonstandard Device; Material Puncture/Hole; Connection Problem; Air/Gas in Device; Collapse; Fluid/Blood Leak; Inflation Problem; Mechanical Problem; Nonstandard Device; Material Puncture/Hole; Connection Problem; Air/Gas in Device

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) WAS NOT WORKING AS THE PUMP REMAINED COLLAPSED WHEN AN ATTEMPT WAS MADE TO INFLATE IT. A PHYSICAL AND ULTRASOUND-ASSISTED EVALUATION WAS PERFORMED. DURING THE ULTRASOUND, IT WAS DETERMINED THAT THE CYLINDERS WERE NOT FULLY EXPANDING. THE PHYSICIAN ACOUSTICALLY DETECTED THE PRESENCE OF AIR IN THE DEVICE AND DETERMINED THAT THE RESERVOIR WAS COMPLETELY EMPTY AND COLLAPSED, LEADING TO THE ASSUMPTION THAT ONE OF THE CYLINDER'S TUBING OR THE TUBE CONNECTING THE PUMP TO THE RESERVOIR HAD RUPTURED. ADDITIONALLY, THE SUSPECTED CAUSE OF THE PUMP ISSUE IS A DISCONNECTION. AS A RESULT, REPLACEMENT SURGERY HAS BEEN PERFORMED TO REMOVE AND REPLACE THE IPP. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23848576 ↗
• InjuryAug 4, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT A PATIENT WITH AN INFLATABLE PENILE PROSTHESIS IPP PRESENTED WITH A NONFUNCTIONING PUMP. A REVISION SURGERY WAS PERFORMED, DURING WHICH THE PHYSICIAN CONFIRMED THAT MANUAL MANIPULATION WAS ATTEMPTED BUT UNSUCCESSFUL. THE DEVICE WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22698087 ↗
• InjuryJul 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) WAS EXPLANTED DUE TO EROSION AND EXTRUSION OF THE DEVICE AT THE DISTAL URETHRAL. IT WAS ALSO NOTED THAT THE PATIENT EXPERIENCED IMPAIRED URINATION AS A RESULT. AT A LATER DATE, THE PATIENT WILL HAVE A NEW IPP IMPLANTED. THERE WERE NO ADDITIONAL PATIENT COMPLICATIONS REPORTED.

  Patient problems: Dysuria; Erosion

  MAUDE report 19754979 ↗
• InjuryJul 12, 2024Fluid/Blood Leak; Mechanical Problem; Fluid/Blood Leak; Mechanical Problem

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) WAS NOT PERFORMING AS EXPECTED DUE TO IT WAS BROKEN. IT WAS ALSO OBSERVED AFTER AN ULTRASOUND EXAMINATION THAT THE PUMP, THE CYLINDERS AND THE RESERVOIR WERE EMPTY. THE IPP WAS EXPLANTED AND REPLACED WITH A TACTRA. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19729240 ↗
• InjuryApr 23, 2024Material 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 PRESENTED WITH THIS INFLATABLE PENILE PROSTHESIS (IPP) THAT WAS NOT WORKING AS INTENDED. TWO WEEKS LATER, SURGICAL INTERVENTION WAS PERFORMED TO REVISE THE IPP, AND A TEAR WAS IDENTIFIED IN THE LEFT CYLINDER. THE PUMP AND CYLINDERS WERE REPLACED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19169537 ↗
• MalfunctionFeb 5, 2024Inflation Problem; Mechanical Problem; Inflation Problem; Mechanical Problem

  IT WAS REPORTED THAT FOLLOWING THE IMPLANT OF THIS INFLATABLE PROSTHESIS, THE PATIENT WAS UNABLE TO INFLATE DUE TO THE HARDNESS OF THE PUMP. THE MRI SHOWED THE CYLINDERS WERE WELL POSITIONED AND THERE WAS A PROBLEM WITH THE PUMP. THE PATIENT WAS INSTRUCTED NOT TO USE THE PUMP. A REVISION SURGERY IS EXPECTED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18639468 ↗
• InjuryJan 29, 2024Inflation Problem; Migration; Inflation Problem; Migration

  IT WAS REPORTED THAT THE PUMP OF THIS INFLATABLE PENILE PROSTHESIS (IPP) HAD MIGRATED TO THE TOP OF THE SCROTUM. THIS RESULTED IN THE DEVICE BEING UNABLE TO INFLATE AND THE PATIENT BEING UNABLE TO OBTAIN AN ERECTION. THE PHYSICIAN ATTEMPTED TO REPOSITION THE PUMP IN OFFICE WITHOUT SUCCESS. SURGICAL INTERVENTION IS PLANNED. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18602922 ↗
• MalfunctionDec 12, 2023Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH AN INFLATABLE PENILE PROSTHESIS (IPP) THAT WAS NO LONGER INFLATING. ULTRASOUND EXAMINATION CONFIRMED THE ISSUE WITH THE PUMP. THERE HAS BEEN NO SURGICAL INTERVENTION AT THIS TIME, AND THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18315495 ↗
• InjuryFeb 5, 2023Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE PATIENT EXPECTED TO HAVE THE INFLATABLE PENILE PROSTHESIS (IPP) REPLACED AS THE PATIENT EXPERIENCED DISCOMFORT WHEN PRESSING THE PUMP. THE IPP DEACTIVATES AFTER INFLATING AND WILL NOT INFLATE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Discomfort

  MAUDE report 16302149 ↗
• InjuryFeb 1, 2023Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole

  IT WAS REPORTED THAT THE PATIENT UNDERWENT SURGICAL INTERVENTION TO EXPLANT THE INFLATABLE PENILE PROSTHESIS (IPP) DUE TO THE DEVICE NOT WORKING PROPERLY. THE PHYSICIAN OBSERVED THAT BOTH CYLINDERS HAD RUPTURED RESULTING IN FLUID LOSS. A NEW IPP WAS IMPLANTED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16278295 ↗
• InjuryJan 11, 2023Migration; Migration

  IT WAS REPORTED THAT A PATIENT WITH AN INFLATABLE PENILE PROSTHESIS (IPP) EXPERIENCED CYLINDER MIGRATION FROM THE CORPORA TO THE SCROTUM LEADING TO A REVISION SURGERY. DURING THE PROCEDURE, THE EXISTING IPP WAS REMOVED AND REPLACED. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16135709 ↗
• MalfunctionMar 8, 2022Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE PATIENT WAS EXPECTED TO UNDERGO A REVISION SURGERY FOR THE INFLATABLE PENILE PROSTHESIS AS THE PUMP STOPPED FUNCTIONING AS INTENDED AFTER ONE MONTH OF THE INITIAL IMPLANT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13690547 ↗
• InjuryFeb 3, 2022Fluid/Blood Leak; Inflation Problem; Mechanical Problem; Fluid/Blood Leak; Inflation Problem; Mechanical Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED INFLATION ISSUES WITH THIS INFLATABLE PENILE PROSTHESIS (IPP). A MAGNETIC RESONANCE IMAGING (MRI) SCAN WAS PERFORMED WHICH INDICATED THAT THE RESERVOIR WAS EMPTY. A REPLACEMENT SURGERY WAS PERFORMED FIVE MONTHS LATER. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13446507 ↗
• InjuryMay 19, 2021Degraded; Adverse Event Without Identified Device or Use Problem; Degraded; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A REVISION OF THIS INFLATABLE PENILE PROSTHESIS (IPP) DUE TO AN ANEURYSM IN THE LEFT CYLINDER ASSOCIATED WITH AN INCREASE IN THE AMOUNT OF PRESSURE THE PUMP REQUIRES TO INFLATE THE PROSTHESIS. IMAGING CONFIRMED THE ANEURYSM. A PATIENT OUTCOME OF STABLE WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11852096 ↗
• InjuryJul 21, 2020Migration; Migration

  IT WAS REPORTED THAT THE PATIENT IS EXPERIENCING DISSATISFACTORY RESULTS WITH HIS INFLATABLE PENILE PROSTHESIS(IPP) DEVICE. THE PATIENT WAS SEEN IN (B)(6) 2019 AND TESTS OF ERECTION AND INFLATION OF THE PROSTHESIS WERE PERFORMED AND AT THE TIME IT WAS IDENTIFIED THAT THE DEVICE ONLY PARTIALLY FILLS AND SHOWS A DEFECT. THE PATIENT IS STILL DISSATISFIED AND REPORTS THAT HIS PENIS IS SWOLLEN AND IN PAIN AND SUSPECTS THE MIGRATION OF THE IPP. THE PATIENT IS REQUESTING A REPLACEMENT OF AN IPP FOR AN AMBICOR PENILE PROSTHESIS(APP) AND THE REVISION IS APPROVED BY THE PHYSICIAN.

  Patient problems: Pain; Swelling

  MAUDE report 10304870 ↗
• InjuryNov 15, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE INFLATABLE PENILE PROSTHESIS (IPP) DEVICE WAS EXPLANTED DUE TO "INFECTION AND EXTRUSION OF THE CONNECTIONS." FURTHER INFORMATION WAS REQUESTED AND NOT YET RECEIVED. PRODUCT WAS EXPLANTED BUT NOT EXPECTED TO BE RETURNED. SHOULD ADDITIONAL INFORMATION BE RECEIVED OR PRODUCT BE RETURNED, A SUPPLEMENTAL REPORT WILL BE FILED UPON COMPLETION OF PRODUCT ANALYSIS.

  Patient problems: Erosion; Unspecified Infection

  MAUDE report 9330822 ↗
• InjuryOct 15, 2019Fluid/Blood Leak; Inflation Problem; Fluid/Blood Leak; Inflation Problem

  IT WAS REPORTED THE PATIENT WILL HAVE HIS INFLATABLE PENILE PROSTHESIS REVISED ON A FUTURE DATE DUE TO FLUID LOSS AND AN INABILITY TO INFLATE THE DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT. ADDITIONAL INFORMATION RECEIVED STATES THE INFLATABLE PENILE PROSTHESIS (IPP) DEVICE WAS EXPLANTED. A NEW 21CM X 12MM IPP DEVICE WITH 100ML RESERVOIR WAS IMPLANTED. FURTHER INFORMATION WAS REQUESTED AND NOT YET RECEIVED. PRODUCT WAS EXPLANTED BUT NOT EXPECTED TO BE RETURNED. SHOULD ADDITIONAL INFORMATION BE RECEIVED OR PRODUCT BE RETURNED, A SUPPLEMENTAL REPORT WILL BE FILED UPON COMPLETION OF PRODUCT ANALYSIS. THIS REPORT WAS ORIGINALLY SUBMITTED VIA ASR. REPORT ID NUMBER FOR THE EVENT: (B)(4). QUARTER/YEAR OF INITIAL ASR REPORT SUBMITTED TO FDA: Q1/2017. ASR EXEMPTION NUMBER: E1197037.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9193712 ↗
• InjuryOct 14, 2019Mechanical Problem; Insufficient Device Problem Information; Mechanical Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT HE INFLATABLE PENILE PROSTHESIS (IPP) DEVICE IS GOING TO BE REMOVED ON A FUTURE DATE DUE TO PAIN AND INFECTION. THE PATIENT "HAS BEEN HAVING CONTINUOUS PAIN IN THE PENIS, ESPECIALLY ON INFLATION. THIS HAS NOT SETTLED DESPITE ANTIBIOTICS AND ANALGESICS, SUGGESTING A CHRONIC INFECTION." AFTER THE DEVICE IS REMOVED IF THERE ARE NO SIGNS OF AN ACTIVE INFECTION THE PHYSICIAN PLANS TO PROCEED WITH AN IMMEDIATE SALVAGE AND REPLACEMENT WITH A NEW DEVICE. IF THERE ARE SIGNS OF AN ACTIVE INFECTION THE PHYSICIAN PLANS TO REMOVE THE DEVICE AND THEN IMPLANT A NEW DEVICE A FEW WEEKS LATER. ADDITIONAL INFORMATION RECEIVED STATES THE PATIENT DID NOT HAVE ANY OTHER SYMPTOMS. HE ONLY REPORTED "CONTINUOUS PAIN, ESPECIALLY ON INFLATION." THE PAIN BEGAN IMMEDIATELY AFTER IMPLANTATION. THE INFECTION WAS LOCATED IN THE SCROTUM. THE "PATIENT HAD SYMPTOM OF CHRONIC INFECTION WHICH MIGHT HAVE AFFECTED THIS IMPLANTATION SURGERY." THE PHYSICIAN DOES NOT BELIEVE THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE INFECTION. THE DEVICE STILL REMAINS IMPLANTED AND IS PLANNED TO BE REMOVED. ADDITIONAL INFORMATION RECEIVED STATES THE EXPLANTED DEVICE WAS "DEFECTIVE."

  Patient problems: Pain; Unspecified Infection

  MAUDE report 9188704 ↗
• MalfunctionOct 14, 2019Degraded; Inflation Problem; Mechanical Problem; Adverse Event Without Identified Device or Use Problem; Degraded; Inflation Problem; Mechanical Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE INFLATABLE PENILE PROSTHESIS (IPP) DEVICE IS GOING TO BE REVISED DUE TO A MALFUNCTION, BULGING ON THE LEFT SIDE OF THE PENIS, AND AN INABILITY TO INFLATE THE CYLINDERS. "PATIENT COMPLAINED OF MALFUNCTION OF THE PENILE PROSTHESIS AND BULGING ON THE LEFT SIDE OF THE PENIS. WHEN BEING EXAMINED, I [DOCTOR] REALLY CONFIRMED THE IMPOSSIBILITY OF FILLING THE CYLINDERS AND OBSERVED THE BULGING OF THE LEFT CAVERNOUS BODY. THE PATIENT IMPLANTED THE FIRST INFLATABLE PENILE PROSTHESIS AMS 700 APPROXIMATELY 15 YEARS AGO AND THIS PERIOD IS THE THIRD TIME THAT THE SAME DEFECT OCCURS. THEREFORE, I [DOCTOR] REQUEST THE USE OF THE WARRANTY TO PERFORM REPLACEMENT AND REPLANTATION OF THE PENILE PROSTHESIS AS SOON AS POSSIBLE." FURTHER INFORMATION WAS REQUESTED AND NOT YET RECEIVED. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

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

  MAUDE report 9186437 ↗