Recall Z-2356-2024 ยท MCM Implant, Cochlear
MED-EL Elektromedizinische Gereate, Gmbh
Mi1250 SYNCHRONY 2, Item Numbers: a) 39541, FLEXSOFT S-Vector; b) 39545, FLEX28 S-Vector; c) 39547, FLEX26 S-Vector; Cochlear Implant
| Date | Jul 12, 2024 (initiated Apr 18, 2024) |
| Status | Open, Classified |
| Reason | A small number of devices may have a higher probability of a crack within the internal electronics substrate which could result in a non-functional device. |
| Root cause | Nonconforming Material/Component |
| Action | MED-EL issued an Urgent-Medical Device Field Safety Notice (FSN) Medical Device Return notice to its sole US consignee (distributor) on 04/18/2024 via email. The notice explained the problem with the device and requested the return of all affected devices. |
| Quantity | 7 devices |
| Distribution | US, Durham, NC |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.