Data Foundry

Medical device recalls 2017

SONNET Mini Battery Pack CableProduct Usage: The SONNET Mini Battery… — Class II medical device recall Z-1395-2017

Terminated recall by MED-EL Elektromedizinische Gereate, Gmbh, reported 2017-03-08, distributed nationwide. Unit Defect: Firm inspection revealed units did not have the compartment lock firmly welded to the housing.

Recall numberZ-1395-2017
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmMED-EL Elektromedizinische Gereate, Gmbh, Innsbruck, N/A, Austria
Recall initiated2016-10-25
Classified2017-03-02
Reported by FDA2017-03-08
Terminated2017-04-04
DistributedNationwide (US)
Countries outside the USBE, CA, DE, FR, GB, HK, IL, NL, PH, PL, PT, TR, UY
Quantity538 units
UPC / GTIN / UDI-DI09008737333720, 09008737333744, 09008737333751, 09008737333768, 09008737333775, 09008737333782
Model numbers32291, 32292, 32293, 32294, 32295, 32296, 33372, 33374, 33375, 33376, 33377, 33378

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.

Reason for recall

Unit Defect: Firm inspection revealed units did not have the compartment lock firmly welded to the housing.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1395-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.