AMS 700 LGX 72404241Recalls & reported problems
Boston Scientific Corporation · Inflatable Penile Prosthesis, 2 Cylinders, InhibiZone treated · Class 3 · Implant
All models of AMS 700 LGX (6)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00878953003535), received between Apr 10, 2019 and Apr 22, 2024 — classified as 3 injuries.
The most frequently reported specific device problem is “Inflation Problem” (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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Inflation Problem1
- Insufficient Device Problem Information1
- Mechanical Problem1
- Use of Device Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryApr 22, 2024Inflation Problem; Mechanical Problem; Inflation Problem; Mechanical Problem
IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) EXHIBITED AUTO INFLATION ISSUES. THE SUSPECTED CAUSE WAS THE RESERVOIR; HOWEVER, A REVISION SURGERY WAS PERFORMED, UPON EXAMINATION IT WAS FOUND THAT THE PUMP WAS RESPONSIBLE FOR THE DEVICE NOT PERFORMING AS EXPECTED. ONLY THE PUMP COMPONENT WAS EXPLANTED, AND A NEW PROCEDURE WAS SCHEDULED TO PLACE A NEW PUMP AT A LATER DATE. NO PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19152969 ↗InjurySep 20, 2019Use of Device Problem; Use of Device Problem
IT WAS REPORTED THAT THE PATIENT UNDERWENT A SURGICAL PROCEDURE TO REPLACE THIS INFLATABLE PENILE PROSTHESIS (IPP) FOR UNSPECIFIED REASONS. THE EXISTING DEVICE WAS REMOVED AND A NEW IPP WAS IMPLANTED. THERE WERE NO PATIENT COMPLICATIONS REPORTED. THE EXPLANTED COMPONENTS ARE NOT EXPECTED FOR RETURN. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THE PROCEDURE WAS PERFORMED AS THE PUMP CEASED TO FUNCTION AFTER SEVERAL MONTHS OF IMPLANT. DURING THE PROCEDURE THE PHYSICIAN NOTED THE PUMP COULD NOT BE ACTIVATED; THE CAUSE OF THE ISSUE COULD NOT BE DETERMINED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9099372 ↗InjuryApr 10, 2019Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT DUE TO AN UNSPECIFIED REASON THE PATIENT HAD HIS INFLATABLE PENILE PROSTHESIS (IPP) CYLINDERS AND PUMP REMOVED AND REPLACED. THE COMPONENTS WERE EXPLANTED AND A NEW DEVICE CONSISTING OF A 18CMX12MM CYLINDERS, PUMP AND RESERVOIR WERE IMPLANTED. SHOULD ADDITIONAL INFORMATION BE RECEIVED A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8501930 ↗
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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