Medtronic DBS Extension Kit for Deep Brain Stimulation recall
Medtronic DBS Extension Kit for Deep Brain Stimulation, Models 37085 and 37086. Sterile
Why was Medtronic DBS Extension Kit for Deep Brain Stimulation 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).
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
all Serial numbers
- Product
- Medtronic DBS Extension Kit for Deep Brain Stimulation, Models 37085 and 37086. Sterile
- Recalling firm
- Medtronic Neuromodulation
- Quantity
- 86,851 (US 37,933 / OUS 48,918)
- Distribution
- worldwide
- Recall date
- May 27, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)