AMS 700 CX MS Pump 72404231Recalls & reported problems

Summary

The FDA's MAUDE database contains 423 adverse event reports that list this exact device (DI 00878953003443), received between Apr 5, 2018 and Sep 4, 2026 — classified as 390 injuries, 33 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (130 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 423 reports, in the reporter's own words as published by the FDA.

• InjurySep 4, 2026Fluid/Blood Leak; Material Puncture/Hole

  It was reported that the pump of this Inflatable Penile Prosthesis (IPP) presented fluid loss due to a hole. A surgical procedure was performed during which the cylinders and pump devices were explanted and replaced with a new ones. There were no patient complications reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50616002 ↗
• InjuryAug 18, 2026Collapse; Fluid/Blood Leak; Inflation Problem; Material Puncture/Hole

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50304647 ↗
• InjuryJul 22, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT A PATIENT WITH AN INFLATABLE PENILE PROSTHESIS (IPP) PRESENTED WITH A FLUID LOSS IN THE SYSTEM. A SURGICAL PROCEDURE WAS PERFORMED DURING WHICH THE DEVICE WAS EXPLANTED AND REPLACED. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25908509 ↗
• InjuryJul 20, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient with this inflatable penile prosthesis (IPP) presented with curvature, resulting in patient dissatisfaction. A surgical procedure was performed during which the IPP was removed and replaced with a Tactra device. It was noted that no device related issues were present, the device cycled properly. No additional information was provided.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 25883611 ↗
• InjuryJul 20, 2026Fluid/Blood Leak; Mechanical Problem

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) WAS NOT WORKING PROPERLY AND HAD FLUID LOSS. AS A RESULT, THE DEVICE WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25876932 ↗
• InjuryJun 11, 2026Fluid/Blood Leak; Inflation Problem; Material Puncture/Hole; Air/Gas in Device

  IT WAS REPORTED THAT THE PATIENT WITH THIS INFLATABLE PENILE PROSTHESIS (IPP) WAS UNABLE TO FULLY INFLATE THE CYLINDERS. UPON INSPECTION, AIR PRESENCE, RUPTURED CYLINDERS AND RELATED FLUID LOSS WERE NOTICED. AS A RESULT, THE DEVICE WAS EXPLANTED AND REPLACED. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25479956 ↗
• InjuryJun 3, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT A PATIENT WITH AN INFLATABLE PENILE PROSTHESIS (IPP) EXPERIENCED PAIN AND DISCOMFORT IN THE SCROTUM, WHERE THE PUMP WAS SITTING. A SURGICAL PROCEDURE WAS PERFORMED TO REMOVE THE IPP. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Discomfort; Pain

  MAUDE report 25385166 ↗
• InjuryMay 27, 2026Inflation Problem

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) WAS NOT GETTING AS FULL AS IT PREVIOUSLY DID. A SURGICAL PROCEDURE WAS PERFORMED DURING WHICH THE DEVICE WAS EXPLANTED AND REPLACED. UPON EXPLANT THE PHYSICIAN DID NOT FIND A LEAK, AND IT WAS SUSPECTED THAT THE CAUSE OF THE INFLATION ISSUE WAS A STRETCH OF THE CORPORA. THE PATIENT FULLY RECOVERED, AND THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25305951 ↗
• InjuryMay 18, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS PATIENT WITH AN INFLATABLE PENILE PROSTHESIS (IPP) EXPERIENCED AN INFECTION. A SURGICAL PROCEDURE WAS PERFORMED DURING WHICH THE DEVICE WAS EXPLANTED AND REPLACED WITH A MALLEABLE PENILE PROSTHESIS DEVICE. THERE WERE NO DEVICE ISSUES REPORTED, AND THERE WERE NO FURTHER PATIENT COMPLICATIONS REPORTED.

  Patient problems: Unspecified Infection

  MAUDE report 25210907 ↗
• InjuryApr 30, 2026Mechanical Problem; Nonstandard Device

  IT WAS REPORTED THAT THE PATIENT WITH THIS INFLATABLE PENILE PROSTHESIS (IPP) EXPERIENCED SCROTAL PAIN AT THE PUMP SITE AND EXPRESSED DISSATISFACTION WITH THE DEVICE. DURING SURGICAL EVALUATION, FRAYING WAS OBSERVED IN THE TUBING CONNECTING THE PUMP TO THE CYLINDER. THE PUMP WAS EXPLANTED AND REPLACED, THE RESERVOIR WAS DRAINED AND REFILLED, AND THE SYSTEM WAS RECONNECTED. THERE WERE NO FURTHER PATIENT COMPLICATIONS REPORTED.

  Patient problems: Pain

  MAUDE report 25053349 ↗
• InjuryApr 28, 2026Inflation Problem; Mechanical Problem

  It was reported that the patient's Inflatable Penile Prosthesis (IPP) was not functioning properly and exhibited inflation issues. It was noted that during the previous replacement surgery, only the connections were replaced, which ultimately resulted in the current device issue. A surgical procedure was performed during which the IPP was replaced with a Tactra device. No patient complications were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25017891 ↗
• InjuryApr 23, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS PATIENT WITH AN INFLATABLE PENILE PROSTHESIS (IPP) IMPLANT DEVICE AND NON-BOSTON SCIENTIFIC RESERVOIR EXPERIENCED PAIN AND AN INFECTION IN THE ABDOMINAL REGION. THE BSC IPP DEVICE WAS WORKING WELL; HOWEVER, IT WAS SUSPECTED THAT THE NON-BSC IPP RESERVOIR MAY HAVE CONTRIBUTED TO THE INFECTION AND PAIN AS THESE CLINICAL SIGNS ORIGINATING AT THE ABDOMINAL AREA. A SURGICAL PROCEDURE WAS PERFORMED A FEW DAYS LATER DURING WHICH THE ENTIRE BSC IPP DEVICE AND NON-BSC IPP RESERVOIR WERE EXPLANTED AND REPLACED WITH A TACTRA DEVICE. THE PHYSICIAN TREATED THE INFECTION BY PRESCRIBING ANTIBIOTICS. THERE WERE NO FURTHER PATIENT COMPLICATIONS REPORTED.

  Patient problems: Abdominal Pain; Unspecified Infection

  MAUDE report 24973465 ↗
• InjuryApr 21, 2026Inflation Problem

  IT WAS REPORTED THAT THE PATIENT WITH AN INFLATABLE PENILE PROSTHESIS (IPP) WAS UNABLE TO INFLATE THE DEVICE. A SURGICAL PROCEDURE WAS PERFORMED TO REMOVE AND REPLACE THE IPP. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24941998 ↗
• InjuryApr 20, 2026Migration

  IT WAS REPORTED THAT THIS PATIENT WITH AN INFLATABLE PENILE PROSTHESIS (IPP) IMPLANT DEVICE EXPERIENCED DISCOMFORT. A SURGICAL PROCEDURE WAS PERFORMED DURING WHICH THE ENTIRE DEVICE WAS EXPLANTED AND REPLACED. UPON EXPLANT, THE PHYSICIAN IDENTIFIED ONE OF THE CYLINDERS HERNIATED OUT OF THE CORPORAL BODY. THERE WERE NO FURTHER PATIENT COMPLICATIONS REPORTED.

  Patient problems: Discomfort; Unspecified Tissue Injury

  MAUDE report 24933371 ↗
• InjuryApr 14, 2026Fluid/Blood Leak; Mechanical Problem

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) PRESENTED A MECHANICAL PROBLEM DUE TO A FLUID LOSS. THE IPP WAS EXPLANTED AND REPLACED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24872667 ↗
• InjuryApr 8, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT WITH THIS INFLATABLE PENILE PROSTHESIS (IPP) EXPERIENCED A DEVICE INFECTION. A SURGICAL PROCEDURE WAS PERFORMED TO REMOVE THE IPP, AND IT WAS REPLACED WITH A TACTRA DEVICE. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Unspecified Infection

  MAUDE report 24821561 ↗
• InjuryMar 31, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WITH AN INFLATABLE PENILE PROSTHESIS (IPP) EXPERIENCED PAIN, SWELLING, AND DISCOMFORT IN THE SCROTAL AREA. MEDICATION WAS ATTEMPTED PRIOR TO SURGICAL INTERVENTION. DURING A REVISION SURGERY, THE PHYSICIAN CONFIRMED THE PRESENCE OF AN INFECTION IN THE SCROTAL AREA. THE DEVICE WAS EXPLANTED, AND THE AREA WAS IRRIGATED. A TACTRA DEVICE WAS IMPLANTED. THERE WERE NO FURTHER PATIENT COMPLICATIONS.

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

  MAUDE report 24744558 ↗
• InjuryMar 30, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WITH AN INFLATABLE PENILE PROSTHESIS (IPP) DEVELOPED AN INFECTION ACCOMPANIED BY AN OPEN WOUND, BOTH LOCATED IN THE SCROTUM. A SURGICAL PROCEDURE WAS PERFORMED, DURING WHICH NO DEVICE ISSUES WERE IDENTIFIED. A WASHOUT WITH ANTIBIOTICS AND A SKIN GRAFT WAS COMPLETED. THE IPP WAS EXPLANTED AND REPLACED WITH A TACTRA DEVICE. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 24737251 ↗
• InjuryMar 16, 2026Inflation Problem; Migration

  IT WAS REPORTED THAT THIS PATIENT WITH AN INFLATABLE PENILE PROSTHESIS (IPP) IMPLANT DEVICE HAD DIFFICULTY PUMPING THEIR DEVICE AND THEY WERE UNABLE TO INFLATE THE IPP. THE PUMP HAD FLIPPED AT ONE POINT. A SURGICAL PROCEDURE WAS PERFORMED DURING WHICH THE DEVICE WAS EXPLANTED AND REPLACED WITH A MALLEABLE PRODUCT. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24612884 ↗
• InjuryMar 10, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT WITH AN INFLATABLE PENILE PROSTHESIS (IPP) DEVELOPED AN INFECTION ACCOMPANIED BY SWELLING. DURING A SUBSEQUENT SURGICAL PROCEDURE, THE IPP WAS REMOVED AND REPLACED WITH A TACTRA DEVICE. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Swelling/ Edema; Unspecified Infection

  MAUDE report 24563759 ↗
• InjuryMar 3, 2026Fluid/Blood Leak; Inflation Problem; Mechanical Problem; Material Puncture/Hole; Migration; Air/Gas in Device

  IT WAS REPORTED THAT THE PATIENT WITH THIS INFLATABLE PENILE PROSTHESIS (IPP) EXPERIENCED TESTICULAR PAIN AND WAS UNABLE TO INFLATE THE DEVICE. A CT SCAN WAS PERFORMED, WHICH SHOWED THAT THE RESERVOIR APPEARED COLLAPSED, WITH AIR PRESENT IN THE PUMP AND CYLINDERS, INDICATING A POSSIBLE SYSTEM LEAK. ADDITIONALLY, ASYMMETRY IN THE DISTAL POSITION OF THE CYLINDERS WAS OBSERVED WITH SUB CENTIMETRIC CALCIFICATIONS IN THE SOFT TISSUES. A FOLLOW UP CT SCAN PERFORMED A FEW MONTHS LATER DEMONSTRATED THAT THE CYLINDERS APPEARED BROKEN, WITH PERSISTENT AIR PRESENCE AND CONTINUED ASYMMETRY IN CYLINDER POSITIONING. THE DEVICE REMAINS IMPLANTED, AND AN EXPLANT SURGERY IS PLANNED. NO ADDITIONAL INFORMATION WAS REPORTED.

  Patient problems: Pain; Unspecified Tissue Injury

  MAUDE report 24502254 ↗
• InjuryFeb 24, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WITH AN INFLATABLE PENILE PROSTHESIS (IPP) PRESENTED WITH AN INFECTED DEVICE. A REVISION SURGERY WAS PERFORMED, DURING WHICH THE PHYSICIAN CONFIRMED THE INFECTION AND STATED THAT THERE WERE NO DEVICE ISSUES. THE DEVICE WAS EXPLANTED AND REPLACED WITH A MALLEABLE PENILE PROSTHESIS. THERE WERE NO FURTHER PATIENT COMPLICATIONS.

  Patient problems: Unspecified Infection

  MAUDE report 24434587 ↗
• InjuryFeb 12, 2026Fluid/Blood Leak; Nonstandard Device; Material Puncture/Hole

  IT WAS REPORTED THAT A PATIENT WITH AN INFLATABLE PENILE PROSTHESIS (IPP) UNDERWENT A REVISION SURGERY DURING WHICH THE PHYSICIAN CONFIRMED A RUPTURE IN THE CYLINDER/PUMP TUBING, AND THE SYSTEM WAS FOUND TO BE EMPTY. THE DEVICE WAS EXPLANTED AND REPLACED. THERE WERE NO REPORTED PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24323234 ↗
• InjuryFeb 10, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WITH AN INFLATABLE PENILE PROSTHESIS (IPP) IMPLANT DEVICE WAS EXPERIENCING AN INFECTION, AND DISCOMFORT AS PUMP WAS STARTING TO COME THROUGH THE SKIN OF THE SCROTUM. THE PHYSICIAN REMOVED THE IPP DEVICE AND REPLACED WITH A TACTRA DEVICE THROUGH REPLACEMENT SURGERY, AND THERE WAS NO FURTHER PATIENT COMPLICATIONS REPORTED.

  Patient problems: Discomfort; Erosion; Unspecified Infection

  MAUDE report 24310344 ↗
• InjuryJan 30, 2026Mechanical Problem

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) WAS NOT WORKING. UPON EXAMINATION, A DISTAL PERFORATION WAS DISCOVERED WHICH WAS NOT CAUSED BY THE SURGEON AT THE TIME OF OPERATION; THEREFORE, THE CASE WAS ABORTED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Perforation

  MAUDE report 24223401 ↗