AMS 700 LGX MS Pump 72404306Recalls & reported problems
Boston Scientific Corporation · Inflatable Penile Prosthesis, Preconnected 1 Pump to 2 Cylinders, Infrapubic · Class 3 · Implant
All models of AMS 700 LGX MS Pump (18)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00878953005768), received between Mar 18, 2025 and Apr 29, 2026 — classified as 2 injuries.
The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (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
- Inadequacy of Device Shape and/or Size1
- Patient-Device Incompatibility1
Patient problems
- Erosion1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryApr 29, 2026Inadequacy of Device Shape and/or Size
IT WAS REPORTED THAT THE PATIENT'S INFLATABLE PENILE PROSTHESIS (IPP) LENGTH WAS REPORTED TO BE TOO SHORT. A SURGICAL PROCEDURE WAS PERFORMED, DURING WHICH THE IPP WAS REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25029685 ↗InjuryMar 18, 2025Patient-Device Incompatibility; Patient-Device Incompatibility
IT WAS REPORTED THAT A PATIENT WITH THIS INFLATABLE PENILE PROSTHESIS EXPERIENCED EROSION IN THE LEFT DISTAL CYLINDER FOR THE PAST TWO MONTHS. ADDITIONALLY, THE PATIENT HAS ARTHRITIS IN THEIR HAND AND REQUESTED THE IMPLANT TO BE REPLACED WITH A MALLEABLE IMPLANT. THE PATIENT UNDERWENT REPLACEMENT SURGERY TO IMPLANT A MALLEABLE IMPLANT. THERE WERE NO FURTHER PATIENT COMPLICATIONS.
Patient problems: Erosion
MAUDE report 21633768 ↗
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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