# P000025: Combi 40+ Cochlear Implant System

- Pathway: PMA
- Applicant: Med-El Corp.
- Decided: Aug 20, 2001 after 417 days
- Product code: MCM (Implant, Cochlear)
- Device class: 3
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. PMA decisions do not claim a predicate device.

## Recalls of this device
- Apr 18, 2024 · Class II · Z-2356-2024: 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.
- Oct 16, 2018 · Class II · Z-2138-2019: Devices were distributed despite the Helium-fine leak test results not being within the cochlear implant standards specification.
- Oct 16, 2018 · Class II · Z-2136-2019: Devices were distributed despite the Helium-fine leak test results not being within the cochlear implant standards specification.
- Oct 16, 2018 · Class II · Z-2137-2019: Devices were distributed despite the Helium-fine leak test results not being within the cochlear implant standards specification.

Source page: https://510kreport.com/device/P000025
Methodology: https://510kreport.com/methodology