SONNET Mini Battery Pack CableProduct Usage: The SONNET Mini Battery Pack Cable is part of the S...
FDA Device Recall #Z-1395-2017 — Class II — October 25, 2016
Recall Summary
| Recall Number | Z-1395-2017 |
| Classification | Class II — Moderate risk |
| Date Initiated | October 25, 2016 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | MED-EL Elektromedizinische Gereate, Gmbh |
| Location | Innsbruck, N/A |
| Product Type | Devices |
| Quantity | 538 units |
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.
Reason for Recall
Unit Defect: Firm inspection revealed units did not have the compartment lock firmly welded to the housing.
Distribution Pattern
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.
Lot / Code Information
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).
Other Recalls from MED-EL Elektromedizinische Gereate, Gmbh
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2356-2024 | Class II | Mi1250 SYNCHRONY 2, Item Numbers: a) 39541, ... | Apr 18, 2024 |
| Z-2136-2019 | Class II | MED EL Cochlear Implant System, Mi1000 MED EL ... | Oct 16, 2018 |
| Z-2137-2019 | Class II | MED EL Cochlear Implant System, SONATATIi100, s... | Oct 16, 2018 |
| Z-2138-2019 | Class II | MED EL Cochlear Implant System, PULSARci100 Sta... | Oct 16, 2018 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.