MED-EL PULSARci100 Cochlear Implant Recalled for Leak Test Failures
MED-EL is recalling PULSARci100 Cochlear Implants because they failed helium-fine leak tests. Affected devices were distributed in the US and several international countries.
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 a high-risk medical device (implantable cochlear implant) with a manufacturing defect (leak test failure) that poses a risk of harm, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
MED-EL Elektromedizinische Geräte GmbH is recalling the MED EL Cochlear Implant System, PULSARci100 Standard. The recall is due to devices being distributed despite the Helium-fine leak test results not being within the cochlear implant standards specification.
The affected devices are identified by Serial Number 202001. The recall covers a quantity of 1 device. Distribution was worldwide, including the United States (specifically California and Illinois) and the following countries: Argentina, Australia, Austria, Brazil, Bulgaria, China, France, Georgia, Korea, Republic of, Poland, Russian Federation, Spain, and Sweden.
The PULSARci100 Implant is an implantable part of the MED EL Cochlear Implant System intended to evoke auditory sensations via electrical stimulation of the auditory pathways for severely to profoundly hearing impaired individuals. Users should contact MED-EL for further instructions regarding the recall.
The recalled product
- Product
- MED EL Cochlear Implant System, PULSARci100 Standard - Product Usage: The PULSARci100 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 e
- Manufacturer
- MED-EL Elektromedizinische Gereate, Gmbh
- Affected units
- 1
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 (1)
- Serial Number 202001
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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