Agency classClass IIOur severity:High FDA (Devices)·Z-3069-2017·Announced 2017-08-30

Medtronic Recalls Deep Brain Stimulation Lead Kits Due to Depth Stop Defect

Medtronic is recalling Deep Brain Stimulation lead kits because the depth stop may not secure properly, potentially causing the lead to be placed beyond the intended target.

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 is classified as FDA Class II. The hazard involves a medical device defect that can lead to incorrect lead placement, which is a risk of harm, but the source text does not report specific injuries or hospitalizations, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Medtronic Neuromodulation is recalling specific Deep Brain Stimulation (DBS) lead kits, including models 3387/3387S, 3389/3389S, and 3391/3391S. The recall involves the DBS Lead Depth Stop, an accessory used during implant procedures to mark distance and control lead depth.

The recall was initiated after Medtronic received reports that the DBS depth stop did not adequately secure to the lead. This defect can result in the DBS lead being placed beyond the intended target during the implant procedure.

The affected products were distributed worldwide, including in the United States and numerous foreign countries. The source text does not specify the number of affected units, specific lot numbers, or reported injuries. Consumers and healthcare providers should contact Medtronic for further instructions on how to proceed with the recall.

The recalled product

Product: DBS Lead Depth Stop contained in Medtronic Deep Brain Stimulation (DBS) lead kits, models 3387/3387S, 3389/3389S, and 3391/3391S, The lead kit contains one DBS lead in addition to multiple accessories used in DBS lead implant procedures. Among these accessories is the DBS lead…
Manufacturer: Medtronic Neuromodulation
Category: Medical Device — Neurostimulation
Hazard: device-malfunction
incorrect-placement
Affected units: 86,024

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 (20)

Model 3387
Lot Serial #: 0206880294
0206882647
0206882779
0206882780
0206882781
0206882782
0206882783
0206886184
0206886323
0206886328
0206886330
0206886331
0206886332
0206886333
0206886603
0206887813
0206890443
0206890444
0206903488

Distribution

Distributed in 47 states:

Same manufacturer · Medtronic Neuromodulation

See all →

Moderate
Medtronic 2x4 pocket adaptor kits carry incorrect use-by dates
FDA (Devices) · 2026-06-03
Moderate
Medtronic 1x4 pocket adaptor kits carry incorrect use-by dates
FDA (Devices) · 2026-06-03
High
Medtronic SynchroMed Flex Infusion Programmer Software Application
FDA (Devices) · 2026-05-20
Moderate
Neurostimulator clinician programmer app recalled over faults during device use
FDA (Devices) · 2026-01-21
High
Femoral nails, 360 mm left trochanteric, recalled over undersized shaft diameter
FDA (Devices) · 2025-12-31

Same hazard · device malfunction