AMS 700 LGX 72404243Recalls & 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
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00878953003559), received between Dec 19, 2023 and Dec 19, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Deflation 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
- Deflation Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 19, 2023Deflation Problem; Deflation Problem
IT WAS REPORTED THAT, DURING A PREPARATION FOR A PROCEDURE TO IMPLANT AN IPP, THE PHYSICIAN DETERMINED THAT THE DEVICE WAS NOT WORKING PROPERLY. WHEN THE PHYSICIAN WAS ATTEMPTING TO DEFLATE THE CYLINDERS, THE BUTTON WAS HELD FOR FIVE SECONDS AND THE CYLINDERS WERE SQUEEZED, BUT THE FLUID DID NOT CYCLE BACK PROPERLY. AN ADDITIONAL ATTEMPT WAS MADE TO DEFLATE WITH THE BUTTON, WHILE SQUEEZING THE SIDES OF THE PUMP BLOCK, BUT THIS DID NOT RESOLVE THE PROBLEM. THE PHYSICIAN DECIDED TO USE A NEW IPP FOR THE IMPLANT AFTER FIVE ATTEMPTS TO RESOLVE THE PUMP PROBLEM. THERE WERE NO PATIENT COMPLICATIONS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18358581 ↗
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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