AMS 700 CX MS Pump 72404235Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00878953003481), received between Nov 27, 2018 and Sep 1, 2026 — classified as 12 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (4 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjurySep 1, 2026Inadequacy of Device Shape and/or Size

  Patient problems: Deformity/ Disfigurement

  MAUDE report 50553495 ↗
• InjuryAug 24, 2026Fluid/Blood Leak

  It was reported that this patient with an Inflatable Penile Prosthesis (IPP) had a surgical procedure was performed during which the device was explanted and replaced. Upon explant the physician identified that the device lost all fluid but the physician did not investigate the device to see where the leak was. There were no patient complications reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50421665 ↗
• InjuryMar 21, 2025Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE PATIENT WAS NO LONGER ABLE TO INFLATE THEIR INFLATABLE PENILE PROSTHESIS DEVICE. DURING A SURGICAL REVISION PROCEDURE, THE PHYSICIAN NOTED THAT THE RESERVOIR WAS DEFLATED UPON REMOVAL WITH NO INDICATION OF THE SOURCE. THE PHYSICIAN DECIDED TO EXPLANT AND REPLACE THE ENTIRE DEVICE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21665518 ↗
• InjuryDec 3, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) PRESENTED FLUID LOSS; THEREFORE, A SURGICAL PROCEDURE WAS PERFORMED TO REMOVED AND REPLACE ALL THE COMPONENTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20832205 ↗
• InjurySep 20, 2024Fluid/Blood Leak; Mechanical Problem; Fluid/Blood Leak; Mechanical Problem

  IT WAS REPORTED THAT THIS PATIENT EXPERIENCED PROBLEMS WITH THIS INFLATABLE PENILE PROSTHESIS (IPP), SINCE THE DEVICE LOST RIGIDITY. UPON EXAMINATION, IT WAS FOUND THE DEVICE HAD A FLUID LEAK. A SURGICAL PROCEDURE WAS PERFORMED AND NO HOLES WERE FOUND IN THE DEVICE, BUT THE CYLINDERS AND PUMP HAD NO FLUID, MEANWHILE THE RESERVOIR WAS STILL FULL OF FLUID; IT WAS SUSPECTED A PROBLEM IN THE PUMP TUBING. ALL COMPONENTS WERE REMOVED AND REPLACED WITH A NEW IPP. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20266134 ↗
• InjuryFeb 1, 2024Collapse; Inflation Problem; Adverse Event Without Identified Device or Use Problem; Air/Gas in Device; Collapse; Inflation Problem; Adverse Event Without Identified Device or Use Problem; Air/Gas in Device

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) WAS NO LONGER WORKING AS EXPECTED DUE TO INFLATION ISSUES. A REVISION SURGERY WAS PERFORMED, UPON EXAMINATION AIR IN THE SYSTEM WAS FOUND. IN ADDITION, THE PUMP WAS REPORTED TO STAY FLAT WHEN PRESSED. THE DEVICE WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18627365 ↗
• MalfunctionJan 5, 2024Inflation Problem; Defective Device; Failure to Deflate; Inflation Problem; Defective Device; Failure to Deflate

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) EXHIBITED DIFFICULTY INFLATING AND DEFLATING. THE PATIENT STATED THAT THE CONNECTORS WERE VISIBLE AND COULD BE FELT MIDDLE THIRD OF THE PENIS. THE DEVICE REMAINS IMPLANTED, AND A REVISION SURGERY HAS NOT YET BEEN SCHEDULED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18451836 ↗
• InjuryMar 13, 2023Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS WAS NOT OPERATING AS INTENDED AND THE RIGHT CYLINDER WAS TORN. THE DEVICE WAS EXPLANTED AND REPLACED WITH A NEW IPP. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16533286 ↗
• InjuryNov 2, 2020Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE PATIENT HAD HIS PREVIOUS INFLATABLE PENILE PROSTHESIS (IPP) REMOVED DUE TO THE DEVICE WAS NOT WORKING, AIR WAS OBSERVED IN THE SYSTEM. A NEW IPP WAS IMPLANTED. NO PATIENT COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10771539 ↗
• InjuryMay 11, 2020Failure to Cycle; Mechanical Problem; Failure to Cycle; Mechanical Problem

  IT WAS REPORTED THAT A FEW MONTHS AGO, THE PATIENT NEEDED PLASTIC TREATMENT FOR LYSIS OF SKIN FLAPS TO TRY TO RELOCATE AN INFLATABLE PROSTHESIS THAT DID NOT WORK PROPERLY. DURING MANIPULATION IN THE INTRAOPERATIVE PERIOD, THE DEVICE DID NOT PRESENT ADEQUATE CYCLING, CORROBORATING A COMPUTED TOMOGRAPHY STUDY THAT DOCUMENTED THE BREAKDOWN OF THE 3-VOLUME INFLATABLE DEVICE. THE PENILE IMPLANT MUST BE REPLACED AND THE URETHRAL OPENING RESULTING FROM CHRONIC USE OF A BLADDER CATHETER MUST BE CORRECTED SIMULTANEOUSLY.

  Patient problems: Complaint, Ill-Defined

  MAUDE report 10045807 ↗
• InjuryJan 9, 2020Inadequacy of Device Shape and/or Size; Adverse Event Without Identified Device or Use Problem; Inadequacy of Device Shape and/or Size; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DUE TO THE CYLINDERS ABOUT TO "REAM TUNICA ALBUGINEA FROM PROXIMAL AND VENTRAL" CAUSING PAIN FOR THE PATIENT. THE PATIENT HAD HIS INFLATABLE PENILE PROSTHESIS (IPP) CYLINDERS REMOVED AND REPLACED WITH 15 CM + 3 CM REAR TIP EXTENDERS AND CYLINDERS. WHEN THE PHYSICIAN REMOVED THE OLD CYLINDERS THE PHYSICIAN ALSO REPAIRED THE TUNICA ALBUGINEA AND RE-DILATED AND RE-MEASURED BEFORE IMPLANTED THE NEW COMPONENTS. IT WAS FURTHER REPORTED THAT THIS SURGERY WAS DUE TO WRONG SIZE OF CYLINDERS. IT WAS STATED THAT THERE WAS ABOUT TO BE DAMAGE TO THE TUNICA ALBUGINA, BUT THE PHYSICIAN CAUGHT IT AND REPAIRED THE ISSUE. THE PATIENT WAS STABLE FOLLOWING THIS SURGERY. ADDITIONAL INFORMATION WAS RECEIVED THAT THE CYLINDERS WERE STARTING TO DAMAGE THE TUNICA ALBUGINA, SO THE PHYSICIAN STATED THAT HE HAD "STOPPED IT."

  Patient problems: Pain; Tissue Damage

  MAUDE report 9570404 ↗
• MalfunctionJan 8, 2020Inadequacy of Device Shape and/or Size; Adverse Event Without Identified Device or Use Problem; Inadequacy of Device Shape and/or Size; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INFLATABLE PENILE PROSTHESIS (IPP) REVISION SURGERY IN WHICH A REAR TIP EXTENDER (RTE) AND A PRECONNECTED PUMP AND CYLINDERS WERE TRIED BUT NOT USED DUE TO UNKNOWN REASON. THE PREVIOUS IMPLANT WAS EXPLANTED AND A NEW IPP WAS IMPLANTED. THE PATIENT IS RECOVERING. EXPLANTED DEVICE WILL BE RETURNED. NO MORE INFORMATION IS AVAILABLE AT THE MOMENT, ADDITIONAL INFORMATION WAS REQUESTED AND WILL BE PROVIDED AS RELEVANT INFORMATION BECOMES AVAILABLE. ADDITIONAL INFORMATION RECEIVED. THE DEVICE WAS TRIED BUT NOT IMPLANTED DUE TO SIZE AND APPROACH CHANGED DURING SURGERY. THE CYLINDER WOULD NOT FIT PROPERLY. IT WAS FURTHER REPORTED THAT NOTHING WAS EXPLANTED, JUST TRIED BUT NOT IMPLANTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9563696 ↗
• InjuryDec 5, 2019Degraded; Defective Device; Degraded; Defective Device

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A REVISION OF AN INFLATABLE PENILE PROSTHESIS(IPP) DEVICE DUE TO A DAMAGED CYLINDER. A PATIENT OUTCOME WAS NOT REPORTED. ADDITIONAL INFORMATION RECEIVED THAT THE REVISION WAS ACTUALLY FOR AN AMBICOR PENILE PROSTHESIS(APP). AN INFLATABLE PENILE PROSTHESIS(IPP) DEVICE WAS IMPLANTED.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 9417481 ↗
• InjuryJan 17, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INFLATABLE PENILE PROSTHESIS (IPP) REPLACEMENT SURGERY DUE TO EROSION. THE PREVIOUS IPP COMPONENTS WERE EXPLANTED PRIOR TO THE REPLACEMENT SURGERY. THE PATIENT WAS IMPLANTED WITH A REPLACEMENT PUMP, AS WELL AS LEFT AND RIGHT CYLINDERS. A REPLACEMENT RESERVOIR WAS NOT IMPLANTED. THE EXPLANTED IPP COMPONENTS ARE NOT EXPECTED TO BE RETURNED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, OR PRODUCT BE RETURNED, A SUPPLEMENTAL REPORT WILL BE FILED UPON COMPLETION OF THE PRODUCT ANALYSIS.

  Patient problems: Erosion

  MAUDE report 8259478 ↗
• MalfunctionNov 27, 2018Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE INFLATABLE PENILE PROSTHESIS (IPP) HAS BROKEN. THE IPP WILL BE REVISED AS THE PATIENT IS IN A WHEELCHAIR AND THE PHYSICIAN BELIEVES HE MAY HAVE "SERIOUS COMPLICATIONS IF HE DOES NOT HAVE AN IMPLANT EXCHANGE." FURTHER INFORMATION WAS REQUESTED AND NOT YET RECEIVED. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8108974 ↗