Medtronic DBS Extension Kit for Deep Brain Stimulation, Models 37085 and 37086. Sterile
Reported: May 27, 2015 Initiated: April 16, 2015 #Z-1617-2015
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).
Details
- Recalling Firm
- Medtronic Neuromodulation
- Units Affected
- 86,851 (US 37,933 / OUS 48,918)
- Distribution
- worldwide
- Location
- Minneapolis, MN
Frequently Asked Questions
What product was recalled? ▼
Medtronic DBS Extension Kit for Deep Brain Stimulation, Models 37085 and 37086. Sterile. Recalled by Medtronic Neuromodulation. Units affected: 86,851 (US 37,933 / OUS 48,918).
Why was this product recalled? ▼
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).
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 27, 2015. Severity: Moderate. Recall number: Z-1617-2015.
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