Z-1617-2015 Class II Terminated
FDA device recall Z-1617-2015 was initiated by Medtronic Neuromodulation on Apr 16, 2015 and is designated Class II. Reason for recall: Medtronic is providing Important information regarding extension handling during implant procedure after receiving reports of high impedances. This applies to extension Models 37085 and 37086 which… The recall status is terminated (terminated Jul 22, 2016). Affected quantity: 86,851 (US 37,933 / OUS 48,918).
Recall Details
- Product Type
- Devices
- Report Date
- May 27, 2015
- Initiation Date
- Apr 16, 2015
- Termination Date
- Jul 22, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 86,851 (US 37,933 / OUS 48,918)
Product Description
Medtronic DBS Extension Kit for Deep Brain Stimulation, Models 37085 and 37086. Sterile
Reason for Recall
Medtronic is providing Important information regarding extension handling during implant procedure after receiving reports of high impedances. This applies to extension Models 37085 and 37086 which can be used with the following implantable Neurostimulators: Activa¿ PC (Model 37601), Activa¿ RC (Model 37612), and the Activa¿ SC (Model 37603).
Distribution Pattern
worldwide
Code Information
all Serial numbers
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1617-2015
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026