Agency classClass IIOur severity:High FDA (Devices)·Z-2432-2018·Announced 2018-07-25

Medtronic Vectris MRI Lead Kit Recalled for Needle Defect

Medtronic is voluntarily recalling Vectris Sure Scan MRI Lead Kits because a manufacturing defect in the curved tip introducer needle may cause difficulty advancing or withdrawing the lead.

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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device with a manufacturing defect that could cause procedural difficulty, fitting the rubric for 'risk-of-harm products where injury has not yet been reported.'

Plain-English summary

Medtronic Neuromodulation is conducting a voluntary recall of the Vectris Sure Scan MRI Lead Kit for Spinal Cord Stimulation. The recall involves specific models (977A160, 977A175, 977A190, 977A260, 977A275, and 977A290) and affects 8,182 units distributed worldwide.

The recall is due to a potential manufacturing defect in the curved tip introducer needle included in the kit. This defect could result in difficulty advancing or withdrawing the Vectris lead through the needle during the implant procedure.

The source text does not specify reported injuries, illnesses, or specific consumer actions beyond the recall notice itself. Patients with implanted devices should contact their healthcare provider for guidance.

The recalled product

Product: Vectris(TM) Sure Scan(R) MRI Lead Kit for Spinal Cord Stimulation, Models: (a) 977A160 (b) 977A175 (c) 977A190 (d) 977A260 (e) 977A275 (f) 977A290 Product Usage: The Medtronic Vectris lead kits contain the implantable spinal cord stimulation lead, as well as additional…
Manufacturer: Medtronic Neuromodulation
Category: Medical Device — Implantable Neurostimulation
Hazard: manufacturing-defect
procedural-difficulty
Affected units: 8,182

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 2 recalled by Medtronic Neuromodulation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Same manufacturer · Medtronic Neuromodulation

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