Reported Apr 26, 2023 · Ongoing

Medtronic SenSight Extension Tunneler Kit, REF B31030; The Extension Tunneler Kit is used to assist in the tunneling…

Medtronic Neuromodulation

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Medtronic Neuromodulation · 7000 Central Ave Ne · Minneapolis, MN · 55432-3568

Is this the product you have?

  • Medtronic SenSight Extension Tunneler Kit, REF B31030; The Extension Tunneler Kit is used to assist in the tunneling and passage of extensions for deep brain stimulation
Lot codes and dates
  • UDI/DI00763000426361
  • Serial Numbers

    73 of 73 codes

    • HG56BR6
    • HG56C4R
    • HG56CJAH01
    • HG56CLE
    • HG586N7
    • HG586UM
    • HG58704
    • HG58VM0
    • HG58VQH
    • HG58VQHH01
    • HG58VY5
    • HG58W7H
    • HG58WWC
    • HG58WYB
    • HG58WYBH01
    • HG58X0E
    • HG597BH
    • HG597DH
    • HG597M8
    • HG59ABH
    • HG59AFC
    • HG59AV6
    • HG59RY0
    • HG5A9GT
    • HG5A9VY
    • HG5A9VZ
    • HG5AQH0
    • HG5AQQE
    • HG5BQ5Y
    • HG5BQLR
    • HG5BQPJ
    • HG5BTW7
    • HG5BTZX
    • HG5BU5W
    • HG5BU77
    • HG5EPSB
    • HG5EQ0C
    • HG5EQ2A
    • HG5EQ69
    • HG5F31N
    • HG5F338
    • HG5F3AZ
    • HG5F3EH
    • HG5F3G6
    • HG5F3K5
    • HG5F3NF
    • HG5FP0Y
    • HG5FP3B
    • HG5FP70
    • HG5FP70H01
    • HG5FPBE
    • HG5HQBM
    • HG5HQF8
    • HG5LJTL
    • HG5LJZQ
    • HG5LK2J
    • HG5LK4H
    • HG5LK5Y
    • HG5LK7C
    • HG5LK8P
  • Serial Numbers
    • HG59ABH
    • HG59RY0
    • HG59SJ4
    • HG59SNC
    • HG5A9H3
    • HG5A9NB
    • HG5A9VY
    • HG5BQ5Y
    • HG5BQAW
    • HG5BQLR
Amount recalled
1414 units

Where it was sold

  • Nationwide

Why it was recalled

Medtronic has received reports of SenSight Extension Tunneler kits that contain dual carriers with have been machined on only one side. As a result, the dual carrier cannot be used to pass two extensions simultaneously.

This product could cause temporary or reversible health problems — stop using it.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 6:56 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.