AMS 700 CXR
Received Jul 27, 2026 · Event occurred Jun 24, 2026
Report 2124215-2026-40052 · MDR key 50037979
Device
Generic name
Prosthesis, Penis, Inflatable
Manufacturer
Boston Scientific CorporationModel number
72404011Catalog number
72404011
Lot number
1000441935
Product problems
- Fluid/Blood Leak
- Material Puncture/Hole
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
It was reported that the tubing connection between the cylinder and the pump of this Inflatable Penile Prosthesis (IPP) ruptured, resulting in fluid leakage near the pump connection. As a result, the device was explanted and replaced. No patient complications were reported.
Additional Manufacturer Narrative
Model Number/Catalog Number: 77404310Serial Number: N/ABatch/Lot Number: 1100088810Model/Catalog Description: PUMP MSUnique Identifier (UDI) #: (01)00878953003986(17)270217(10)1100088810Model Number/Catalog Number: 720182-01Serial Number: N/ABatch/Lot Number: 1000527876Model/Catalog Description: RESERVOIR FLAT 100 MLUnique Identifier (UDI) #: (01)00878953005676(17)260214(10)1000527876