AMS 700 CX MS PUMP
Received Jul 21, 2026 · Event occurred Jun 24, 2026
Report 2124215-2026-39291 · MDR key 25894839
Device
Generic name
Prosthesis, Penis, Inflatable
Manufacturer
Boston Scientific CorporationModel number
72404231Catalog number
72404231
Lot number
1100272436
Product problems
- Fluid/Blood Leak
- Mechanical Problem
- Material Puncture/Hole
Patient
78 YR · Male
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT A PATIENT WITH AN INFLATABLE PENILE PROSTHESIS (IPP) PRESENTED WITH A NONFUNCTIONING PUMP. A REVISION SURGERY WAS PERFORMED, DURING WHICH THE PHYSICIAN CONFIRMED FLUID LOSS IN THE SYSTEM DUE TO FRACTURED PUMP TUBING. THE DEVICE WAS EXPLANTED AND REPLACED. THERE WERE NO PATIENT COMPLICATIONS.
Additional Manufacturer Narrative
MODEL NUMBER/CATALOG NUMBER: 720185-01. SERIAL NUMBER: N/A. BATCH/LOT NUMBER: 1100298203. MODEL/CATALOG DESCRIPTION: RESERVOIR, FLAT, IZ, 100 ML. UNIQUE IDENTIFIER (UDI) #: (B)(4).