Z-1395-2017Class II

SONNET Mini Battery Pack CableProduct Usage: The SONNET Mini Battery Pack Cable is part of the SONNET Mini...

Name: Z-1395-2017 SONNET Mini Battery Pack CableProduct Usage: The SONNET Mini Battery Pack Cable is part of the SONNET Mini...
Creator: MED-EL Elektromedizinische Gereate, Gmbh
Published: 2016-10-25
License: https://open.fda.gov/license/

Med-el Elektromedizinische Geraete, GmbH / initiated 2016-10-25 / Terminated / root cause: design

FDA source

MED-EL Elektromedizinische Gereate, Gmbh began a recall of 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... on 2016-10-25. FDA classified it as Class II and gives the reason as "Unit Defect: Firm inspection revealed units did not have the compartment lock firmly welded to the housing". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1395-2017
Classification: Class II
Status: Terminated
Initiated: 2016-10-25
Posted: 2017-03-02
Terminated: 2017-04-04
Recalling firm: Med-el Elektromedizinische Geraete, 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.
Product code: ISM Pylon, Post Surgical
Reason for recall: Unit Defect: Firm inspection revealed units did not have the compartment lock firmly welded to the housing.
Root cause tag: design
FDA 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 in commerce: 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.
Product codes and lots: 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).

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1395-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1395-2017	Class II	Terminated	Voluntary: Firm initiated	2017-03-08	2017-03-02

Product code ISM

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)