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.
What this means for you
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: The recall involves an implantable medical device with a defect in its leak test, which is a risk-of-harm product where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
MED-EL Elektromedizinische Geräte GmbH is recalling 10 units of the MED EL Cochlear Implant System, SONATAti100. The recall covers three specific implant types: SONATAti100 FLEXsoft, SONATAti100 H Standard, and SONATAti100 Standard. These devices are intended for severely to profoundly hearing impaired individuals who obtain little or no benefit from acoustic amplification.
The recall was initiated because the devices were distributed despite the Helium-fine leak test results not being within the cochlear implant standards specification. This indicates a potential failure in the integrity of the implant's seal.
The affected devices were distributed worldwide, including in the United States (California and Illinois) and in Argentina, Australia, Austria, Brazil, Bulgaria, China, France, Georgia, Korea, Poland, the Russian Federation, Spain, and Sweden. Specific serial numbers for the affected units are listed in the agency's recall record. Patients with these implants should contact their healthcare provider or MED-EL for instructions on next steps.
The recalled product
- 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
- Manufacturer
- MED-EL Elektromedizinische Gereate, Gmbh
- Hazard
- Affected units
- 10
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. 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.
Distribution
Part of a larger recall action
This product is one of 3 recalled by MED-EL Elektromedizinische Gereate, Gmbh under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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