Cochlear implant devices recalled for potential internal electronics substrate defect
MED-EL Mi1250 SYNCHRONY 2 cochlear implants may have cracks in their internal electronics substrate that could cause device failure. Seven devices distributed to Durham, North Carolina are affected.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II medical device recall for a manufacturing defect affecting an implantable device. While no injuries or illnesses have been reported, a non-functional cochlear implant represents a significant risk of harm to patients who depend on the device for hearing.
Plain-English summary
MED-EL Elektromedizinische Gerate, Gmbh is recalling seven Mi1250 SYNCHRONY 2 cochlear implants because they may contain a crack in the internal electronics substrate that could result in device failure.
The recalled devices consist of three models with the following item numbers and affected serial numbers: FLEXSOFT S-Vector (Item 39541, Serial 859106), FLEX28 S-Vector (Item 39545, Serials 860731, 860782, 863380), and FLEX26 S-Vector (Item 39547, Serials 860757, 860772, 863386). These seven devices were distributed to Durham, North Carolina.
Patients or healthcare providers who believe they have received one of these devices should contact MED-EL or their healthcare provider for additional information and guidance.
The recalled product
- Product
- Mi1250 SYNCHRONY 2, Item Numbers: a) 39541, FLEXSOFT S-Vector; b) 39545, FLEX28 S-Vector; c) 39547, FLEX26 S-Vector; Cochlear Implant
- Manufacturer
- MED-EL Elektromedizinische Gereate, Gmbh
- Affected units
- 7
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (13)
- a) 39541
- UDI/DI 09008737395414
- Serial Numbers: 859106
- b) 39545
- UDI/DI 09008737395452
- Serial Numbers: 860731
- 860782
- 863380
- c) 39547
- UDI/DI 09008737395476
- Serial Numbers: 860757
- 860772
- 863386
Distribution
Distributed in 1 state:
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