Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Specify 5-6-5 Lead Recalled by Medtronic Neuromodulation Due to Some Specify 5-6-5 and 2x8 surgical lead product...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Medtronic Neuromodulation directly.
Affected Products
Specify 5-6-5 Lead, Specify 2x8 Lead, Model Numbers: 39565, 39286. Spinal cord stimulation leads. Part of a neurostimulation system for treating chronic, intractable pain of the trunk and/or limbs-including unilateral or bilateral pain.
Quantity: 51,138 (44,006 US; 9,132 OUS)
Why Was This Recalled?
Some Specify 5-6-5 and 2x8 surgical lead product labeling does not adequately distinguish between permanent surgical implant and trialing/screening use.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Medtronic Neuromodulation
Medtronic Neuromodulation has 95 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report