# FDA recall Z-2432-2018

> **Medtronic Neuromodulation** · Class II · device recall initiated 2018-05-25.

## 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 components used for lead implant as part of a Neurostimulation system for pain therapy. A Medtronic implantable Neurostimulation system is indicated for spinal cord stimulation (SCS) systems as an aid in the management of chronic, intractable pain of the trunk and/or limbs-including unilateral or bilateral pain associated with the following conditions: Failed Back Syndrome (FBS) or low back syndrome or failed back; Radicular pain syndrome or radiculopathies resulting in pain secondary to FBS or herniated disk; Post laminectomy pain; Multiple back operations; Unsuccessful disk surgery; Degenerative Disk Disease (DDD)/herniated disk pain refractory to conservative and surgical interventions; Peripheral causalgia; E

## Reason for recall

This voluntary recall is being conducted due to the curved tip introducer needle which is included in the kit, to have a potential manufacturing defect.  This could result in difficulty advancing or withdrawing the Vectris lead through the curved tip introducer needle.

## Distribution

Worldwide

## Key facts

- **Recall number:** Z-2432-2018
- **Recalling firm:** Medtronic Neuromodulation
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-05-25
- **Report date:** 2018-07-25
- **Termination date:** 2020-12-11

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Minneapolis, MN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2432-2018

## Citation

> AI Analytics. FDA recall Z-2432-2018. Retrieved 2026-06-08 from https://api.ai-analytics.org/recall/Z-2432-2018. Source: US FDA. Licensed CC0.

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