MED-EL SONATAti100 Cochlear Implant Recall for Leak Test Failures
MED-EL is recalling 10 SONATAti100 cochlear implants because they failed helium-fine leak tests. The devices were distributed despite not meeting specifications.
- Product
- MED EL Cochlear Implant System, SONATATIi100, sold under the following implant types: a. SONATAti100 FLEXsoft; b. SONATAti100 H Standard; c. SONATAti100 Standard Product Usage: The SONATATIi100 Implant is an implantable part of the MED EL Cochlear Implant System
- Category
- Medical Device
- Distribution
- Distributed nationwide