AMS 700 CX 72404172Recalls & reported problems
Boston Scientific Corporation · Inflatable Penile Prosthesis, 2 Cylinders, InhibiZone treated · Class 3 · Implant
All models of AMS 700 CX (6)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00878953003269), received between Dec 7, 2018 and Oct 24, 2024 — classified as 5 injuries.
The most frequently reported specific device problem is “Defective Device” (1 report).
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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem4
- Defective Device1
- Fluid/Blood Leak1
- Inflation Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- No Known Impact Or Consequence To Patient1
- Perforation1
- Unspecified Infection1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
InjuryOct 24, 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 SURGERY DUE TO UNSPECIFIED REASONS; HOWEVER, UPON ANALYSIS OF THE RETURNED COMPONENTS, A WEAR AT FOLD IN THE PROXIMAL END AND MIDDLE OF THE FIRST CYLINDER WAS IDENTIFIED, AND IN ADDITION, IT WAS NOTED THAT THE KINK RESISTANT TUBING (KRT) OF THE PUMP WERE WORN TO THE FILAMENT, AND ALSO THE PUMP DID NOT PASS THE VALVE ACTIVATE STATE TEST. THERE WERE NO PATIENT COMPLICATIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20526120 ↗InjuryJun 28, 2023Fluid/Blood Leak; Inflation Problem; Adverse Event Without Identified Device or Use Problem; Fluid/Blood Leak; Inflation Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT EXPERIENCED INFLATION ISSUES WITH AN INFLATABLE PENILE PROSTHESIS (IPP) LEADING TO A REPLACEMENT SURGERY. DURING THE PROCEDURE, FLUID LOSS WAS NOTED; HOWEVER, ITS SOURCE WAS NOT DETECTED. THERE WERE NO PATIENT COMPLICATIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17221380 ↗InjuryMay 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) BREACHED THE CAVERNOUS WALL OF THE PATIENT. IT WAS DETAILED THAT THE IMPLANT IS STILL WORKING PROPERLY, AND A REVISION SURGERY HAS NOT BEEN SCHEDULED YET. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Perforation
MAUDE report 16908388 ↗InjuryJan 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT PRESENTED WITH AN INFECTION OF HIS INFLATABLE PENILE PROSTHESIS (IPP). THEREFORE, THE IPP WAS EXPLANTED. THERE WERE NO FURTHER PATIENT COMPLICATIONS REPORTED.
Patient problems: Unspecified Infection
MAUDE report 16218746 ↗InjuryDec 7, 2018Defective Device; Defective Device
IT WAS REPORTED THAT AN INFLATABLE PENILE PROSTHESIS (IPP) WAS REVISED DUE TO PATIENT DISSATISFACTION OF NOT STIFF ENOUGH. THE CYLINDER WAS REMOVED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT. FURTHER INFORMATION WAS REQUESTED AND IS NOT YET AVAILABLE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS COMPLAINT WILL BE REASSESSED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8144649 ↗
Other Prosthesis, Penis, Inflatable devices
- AMS 700 MS Pump 72404310Boston Scientific Corporation · Prosthesis, Penis, Inflatable992 reports
- AMS 700 LGX MS Pump 72404252Boston Scientific Corporation · Prosthesis, Penis, Inflatable1 death757 reports
- AMS 700 CX MS Pump 72404233-12Boston Scientific Corporation · Prosthesis, Penis, Inflatable656 reports
- AMS 700 CX MS Pump 72404232Boston Scientific Corporation · Prosthesis, Penis, Inflatable639 reports
- AMS 700 LGX MS Pump 72404251Boston Scientific Corporation · Prosthesis, Penis, Inflatable611 reports
- Conceal 720185-01Boston Scientific Corporation · Prosthesis, Penis, Inflatable586 reports
- AMS 700 LGX MS Pump 72404252-10Boston Scientific Corporation · Prosthesis, Penis, Inflatable561 reports
- AMS 700 CX MS Pump 72404232-10Boston Scientific Corporation · Prosthesis, Penis, Inflatable533 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page