Agency classClass IIOur severity:Moderate FDA (Devices)·Z-0859-2016·Announced 2016-03-02

Medtronic Spinal Cord Stimulation Leads Recalled for Labeling Deficiencies

Medtronic is recalling Specify 5-6-5 and 2x8 spinal cord stimulation leads because the labeling does not adequately distinguish between permanent implant and trialing use.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, which typically indicates a situation where use of the product may cause temporary or medically reversible adverse health consequences. The hazard is a labeling error rather than a structural defect or contamination, and no injuries or illnesses are reported in the source text.

Plain-English summary

Medtronic Neuromodulation is recalling the Specify 5-6-5 Lead and Specify 2x8 Lead (Model Numbers 39565 and 39286). These products are spinal cord stimulation leads that are part of a neurostimulation system used to treat chronic, intractable pain of the trunk and/or limbs, including unilateral or bilateral pain.

The recall was initiated because the product labeling does not adequately distinguish between permanent surgical implant and trialing or screening use. This labeling deficiency could potentially lead to confusion regarding the intended use of the device during surgical procedures.

The recall affects 51,138 units, including 44,006 in the United States and 9,132 outside the United States. The products were distributed worldwide, including nationwide in the US. All lot and serial numbers for Model Numbers 39565 and 39286 are affected. Healthcare providers and patients should contact Medtronic Neuromodulation for further instructions regarding the return or replacement of these devices.

The recalled product

Product: 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.
Manufacturer: Medtronic Neuromodulation
Category: Medical Device — Neurostimulation
Hazard: mis-labeling

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

All lot/serial numbers are affected for both Model numbers: 39565 and 39286

Distribution

Distributed nationwide across the United States.

Same manufacturer · Medtronic Neuromodulation

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