CLASS II Device recall · Reported 3 Jun 2020 · FDA Enforcement Report

ArtisanTM Surgical Lead Kit recalled by Boston Scientific

Boston Scientific Neuromodulation is recalling ArtisanTM Surgical Lead Kit. The recall was initiated on 24 Apr 2019 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesPart number M365SC8216700; serial numbers 632107 and 645608

Quantity recalled2 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2119-2020
FDA event ID: 84983
Recalling firm: Boston Scientific Neuromodulation, Valencia, CA
Classification: Class II
Status: Terminated
Recall initiated: 24 Apr 2019
FDA classified: 26 May 2020
Reported: 3 Jun 2020
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Spinal Implants

Timeline

24 Apr 2019	Recall initiated by company
26 May 2020	Classified by FDA	+398 days
3 Jun 2020	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

The firm is initiating a voluntary removal of certain spinal cord stimulation leads, lead extensions, adapters, and deep brain stimulation lead extensions due to the "use by date" displayed on the label which is later than the correct "use by date". No adverse health consequence is expected to occur from this issue.

Product as listed by the FDA

ArtisanTM 70 cm 2 x 8 Surgical Lead Kit, part number M365SC8216700. 2 x 8 Surgical Paddle Lead Kit: (1) One Paddle Lead (4); Four Suture Sleeves; (2) Lead Position Labels, left and right (Non-Sterile); (1) Device Registration Form/Temporary Patient Identification Card; (1) Manual - Product Usage: The surgical paddle leads function as a component of Boston Scientific s spinal cord stimulator (SCS) systems by delivering electrical stimulation to the nerve structures in the dorsal aspect of the spinal cord, resulting in a inhibition of pain sensation.

Where it was distributed

Distributed OUS only. to 14 countries.

Questions about this recall

Why was it recalled?

Which lots are affected?

Part number M365SC8216700; serial numbers 632107 and 645608

Where was it sold?

Distributed OUS only. to 14 countries.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

6 other products · FDA event 84983

This product is part of a recall event; the main page for the event is Thirty-five cm 8 Contact Extension Kit recalled by Boston Scientific.

Reported	Class	Recall	Company	Reason	Where
3 Jun 2020	CLASS II	Thirty-five cm 8 Contact Extension Kit recalled by Boston Scientific	Boston Scientific Neuromodulation	Packaging Defects	CA
3 Jun 2020	CLASS II	LinearTM 3-4 8 Contact Lead Kit recalled by Boston Scientific	Boston Scientific Neuromodulation	Packaging Defects	CA
3 Jun 2020	CLASS II	Fifty-five cm 8 Contact Extension Kit recalled by Boston Scientific	Boston Scientific Neuromodulation	Other	CA
3 Jun 2020	CLASS II	Fifty-five cm 8 Contact Extension Kit recalled by Boston Scientific	Boston Scientific Neuromodulation	Packaging Defects	CA
3 Jun 2020	CLASS II	Precision TM M8 Adapter recalled by Boston Scientific	Boston Scientific Neuromodulation	Other	CA
3 Jun 2020	CLASS II	The LinearTM 3-4 8 Contact Lead Kit recalled by Boston Scientific	Boston Scientific Neuromodulation	Packaging Defects	CA

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