Recall Z-1617-2015— Medtronic Neuromodulation
Class II · Terminated
Class II FDA medical device recall by Medtronic Neuromodulation, initiated 2015-04-16, terminated 2016-07-22. FDA's recall record names no specific 510(k) clearance for this event. Product: Medtronic DBS Extension Kit for Deep Brain Stimulation, Models 37085 and 37086. Sterile. Reason: 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)..
- Recalling firm
- Medtronic Neuromodulation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-04-16
- Terminated
- 2016-07-22
- Firm location
- Minneapolis, MN, United States
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).
Data sourced from openFDA. This site is unofficial and independent of the FDA.