SONNET Mini Battery Pack CableProduct Usage recallZ-1395-2017 · MED-EL Elektromedizinische Gereate, Gmbh · initiated Oct 25, 2016
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from MED-EL Elektromedizinische Gereate, Gmbh or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Unit Defect: Firm inspection revealed units did not have the compartment lock firmly welded to the housing.
FDA root cause category: Device Design
What the company is doing
MED-EL is notifying all consignees to whom affected products have been directly shipped by Headquarters (based on first delivery shipment records) on 10/25/2016.
Recall details
- Recall number
- Z-1395-2017
- Status
- Terminated
- Initiated by the company
- Oct 25, 2016
- Posted by the FDA
- Mar 2, 2017
- Recalling firm
- MED-EL Elektromedizinische Gereate, Gmbh
- Quantity
- 538 units
- Product code
- ISM
- FDA submissions
- P000025S087
- Distribution
- Worldwide Distribution - US Nationwide in the states of CA, NC and TX; and the countries of Belgium, Belarus, Canada, France, Germany, Hong Kong, Israel, Netherlands, Philippines, Poland, Portugal, Turkey, United Kingdom, and Uruguay.
Product description
SONNET Mini Battery Pack CableProduct Usage: The SONNET Mini Battery Pack Cable is part of the SONNET Mini Battery Pack, which is an external battery pack used to power one MED-EL SONNET control unit. It can be worn on the upper body or the hip using different SONNET Mini Battery Pack Cable lengths to connect the SONNET Mini Battery Pack to one processor unit.
Code information (models, lots, serial numbers)
Part No. 32291, Kit 33372, Kit UDI - Primary ID: 09008737333720 (anthracite 50); Part No. 32292, Kit 33374, Kit UDI - Primary ID: 09008737333744 (ebony 50); Part No. 32293, Kit 33375, Kit UDI - Primary ID: 09008737333751 (black 50); Part No. 32294, Kit 33376, Kit UDI - Primary ID: 09008737333768 (white 50); Part No. 32295, Kit 33377, Kit UDI - Primary ID: 09008737333775 (beige 50) and Part No. 32296, Kit 33378, Kit UDI - Primary ID: 09008737333782 (grey 50).
Devices named in this recall
6 devices in the FDA device registry whose identifier appears in the recall's code information.
- SONNET Mini Battery Pack Kit anthracite 50 cm 33372Med-El Elektromedizinische Geräte Gesellschaft m.b.H. · Implant, Cochlear1 recall0 reports
- SONNET Mini Battery Pack Kit ebony 50 cm 33374Med-El Elektromedizinische Geräte Gesellschaft m.b.H. · Implant, Cochlear1 recall0 reports
- SONNET Mini Battery Pack Kit black 50 cm 33375Med-El Elektromedizinische Geräte Gesellschaft m.b.H. · Implant, Cochlear1 recall0 reports
- SONNET Mini Battery Pack Kit white 50 cm 33376Med-El Elektromedizinische Geräte Gesellschaft m.b.H. · Implant, Cochlear1 recall0 reports
- SONNET Mini Battery Pack Kit beige 50 cm 33377Med-El Elektromedizinische Geräte Gesellschaft m.b.H. · Implant, Cochlear1 recall0 reports
- SONNET Mini Battery Pack Kit grey 50 cm 33378Med-El Elektromedizinische Geräte Gesellschaft m.b.H. · Implant, Cochlear1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
How recalls are matched to devices · Editorial policy · Report an error on this page