AMS 700 CX MS Pump
Received Jul 27, 2026 · Event occurred Jun 29, 2026
Report 2124215-2026-40042 · MDR key 50037254
Device
Generic name
Prosthesis, Penis, Inflatable
Manufacturer
Boston Scientific CorporationModel number
72404232-10Catalog number
72404232-10
Lot number
1100875655
Product problems
- Fluid/Blood Leak
- Inflation Problem
- Material Puncture/Hole
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
It was reported that the patient with this Inflatable Penile Prosthesis (IPP) was unable to inflate his device. Upon inspection, a hole in the cylinder and related fluid loss. As a result, the device was explanted and replaced. No patient complications were reported.
Additional Manufacturer Narrative
Model Number/Catalog Number: 720185-01Serial Number: N/ABatch/Lot Number: 1100855404Model/Catalog Description: RESERVOIR FLAT IZ 100 MLUnique Identifier (UDI) #: (01)00878953005669(17)271218(10)1100855404