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 and can only be used together with compatible MED EL external components. The MED EL Cochlear Implant System is intended to evoke auditory sensations via electrical stimulation of the auditory pathways for severely to profoundly hearing impaired individuals who obtain little or no benefit from acoustic amplification in the best aided condition.
Class I - DangerousWhat Should You Do?
- Check if you have this product: a. SONATAti100 FLEXsoft, Serial Number 150489; b. SONATAti100 H Standard, Serial Numbers 146714, 164324; c. SONATAti100 Standard, Serial Numbers 145179, 217623, 144443, 145228, 158919, 147748, 223013.
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- MED-EL Elektromedizinische Gereate, Gmbh
- Reason for Recall:
- Devices were distributed despite the Helium-fine leak test results not being within the cochlear implant standards specification.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
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 and can only be used together with compatible MED EL external components. The MED EL Cochlear Implant System is intended to evoke auditory sensations via electrical stimulation of the auditory pathways for severely to profoundly hearing impaired individuals who obtain little or no benefit from acoustic amplification in the best aided condition.
Product Codes/Lot Numbers:
a. SONATAti100 FLEXsoft, Serial Number 150489; b. SONATAti100 H Standard, Serial Numbers 146714, 164324; c. SONATAti100 Standard, Serial Numbers 145179, 217623, 144443, 145228, 158919, 147748, 223013.
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2137-2019
Related Recalls
Mi1250 SYNCHRONY 2, Item Numbers: a) 39541, FLEXSOFT S-Vector; b) 39545, FLEX28 S-Vector; c) 39547, FLEX26 S-Vector; Cochlear Implant
MED-EL Elektromedizinische Gereate, Gmbh
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.
Devices were distributed despite the Helium-fine leak test results not being within the cochlear implant standards specification.
Devices were distributed despite the Helium-fine leak test results not being within the cochlear implant standards specification.