AMS 700 LGX MS PUMP
Received Jul 14, 2026 · Event occurred Dec 8, 2025
Report 2124215-2026-37914 · MDR key 25821013
Device
Generic name
Prosthesis, Penis, Inflatable
Manufacturer
Boston Scientific CorporationModel number
72404252-10Catalog number
72404252-10
Lot number
1100819703
Product problems
- Inflation Problem
- Failure to Deflate
Patient
57 YR · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
MODEL NUMBER/CATALOG NUMBER: 720185-01. SERIAL NUMBER: N/A. BATCH/LOT NUMBER: 1100814015. MODEL/CATALOG DESCRIPTION: RESERVOIR FLAT IZ 100 ML. UNIQUE IDENTIFIER (UDI) #: (B)(4). B3: DATE IS UNKNOWN, SO ESTIMATED DATE WAS ENTERED.
Description of Event or Problem
IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) WAS DIFFICULT TO INFLATE AND DEFLATE. A SURGICAL PROCEDURE WAS PERFORMED DURING WHICH THE DEVICE WAS EXPLANTED AND REPLACED WITH A MALLEABLE DEVICE. THE PATIENT FULLY RECOVERED, AND NO ADDITIONAL INFORMATION WAS PROVIDED.