FDA Medical Device Recalls (openFDA)
MED-EL Elektromedizinische Gereate, Gmbh: 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.
- Recall number
- Z-1395-2017
- Recalling firm
- MED-EL Elektromedizinische Gereate, Gmbh
- Product
- 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.
- Status
- Terminated
- Initiated
- 2016-10-25
- Posted
- 2017-03-02
- Terminated
- 2017-04-04
- Reason
- Unit Defect: Firm inspection revealed units did not have the compartment lock firmly welded to the housing.
- Root cause
- Device Design
- Action
- 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.
- Quantity
- 538 units
- 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.
- Lot, serial or model codes
- 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).
- 510(k) numbers
- not on file
- PMA numbers
- ["P000025S087"]
- Product code
- ISM
- Firm FEI
- 3000249315
- Firm city
- Innsbruck
- Firm state
- not on file
- Firm country
- Austria
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28