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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 84983

7 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
April 24, 2019
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Boston Scientific Neuromodulation Corporation

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

7 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 7

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.

Z-2119-2020
Recall number
Z-2119-2020
Initiated
April 24, 2019
Classification
Class II
Status
Terminated
Quantity
2 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling Change Control

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Part number M365SC8216700; serial numbers 632107 and 645608

Distribution pattern

Distributed OUS only. to 14 countries.

device · product 2 of 7

Thirty-five (35) cm 8 Contact Extension Kit, part number M365SC3138350. Package Contents: Lead Extension Kit (1) Lead Extension (1) Hex Wrench (1) Tunneling Tool Assembly (1) Device Registration Form/Temporary Patient Identification Card (1) Manual Product Usage: Contact extension kits are part of a spinal cord stimulation system for prescription use only as an aid in the management of chronic intractable pain of the trunk and/or limbs. They are designed to connect the percutaneous leads to the Implantable Pulse Generator (IPG) for spinal cord stimulation.

Z-2120-2020
Recall number
Z-2120-2020
Initiated
April 24, 2019
Classification
Class II
Status
Terminated
Quantity
19 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling Change Control

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Part number M365SC3138350; serial numbers 1041034, 1055172, 3000549, 1041380, 1056806, 3000564, 1053375, 1058008, 3001907, 1053695, 1058015, 3007457, 1053700, 1058017, 3008119, 1054299, 1062660, 1054304, and 1064590.

Distribution pattern

Distributed OUS only. to 14 countries.

device · product 3 of 7

LinearTM 3-4 50 cm 8 Contact Lead Kit, part number M365SC2352500. Leads function as a component of Boston Scientific's Spinal Cord Stimulation (SCS) systems by delivering electrical stimulation to the nerve structures in the dorsal aspect of the spinal cord, resulting in an inhibition of pain sensation. Package Contents Percutaneous Permanent Lead Kits (1) Percutaneous Lead with pre-loaded Curved Stylet (1) Stylet Ring with a Curved and a Straight Stylet (4) Suture Sleeves (1) Insertion Needle with Stylet (1) Lead Blank (1) Steering Cap (1) OR Cable Assembly (2) Lead Position Labels left and right (non-sterile) (1) Device Registration Form/Temporary Patient Identification Card (1) Manual

Z-2121-2020
Recall number
Z-2121-2020
Initiated
April 24, 2019
Classification
Class II
Status
Terminated
Quantity
3 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling Change Control

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Part number M365SC2352500; serial numbers 1039736, 1039779, and 1042340.

Distribution pattern

Distributed OUS only. to 14 countries.

device · product 4 of 7

The LinearTM 3-4 70 cm 8 Contact Lead Kit, part number M365SC2352700 is part of a spinal cord stimulation system for prescription use only as an aid in the management of chronic intractable pain of the trunk and/or limbs. Package Contents Percutaneous Permanent Lead Kits (1) Percutaneous Lead with pre-loaded Curved Stylet (1) Stylet Ring with a Curved and a Straight Stylet (4) Suture Sleeves (1) Insertion Needle with Stylet (1) Lead Blank (1) Steering Cap (1) OR Cable Assembly (2) Lead Position Labelsleft and right (non-sterile) (1) Device Registration Form/Temporary Patient Identification Card (1) Manual

Z-2122-2020
Recall number
Z-2122-2020
Initiated
April 24, 2019
Classification
Class II
Status
Terminated
Quantity
1 unit

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling Change Control

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Part number M365SC2352700; serial number 1042757.

Distribution pattern

Distributed OUS only. to 14 countries.

device · product 5 of 7

Precision TM M8 Adapter, 15 cm, part number M365SC9218150 - Product Usage: The adapter is part of a spinal cord stimulation system for prescription use only indicated 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: failed back surgery syndrome, Complex Regional Pain Syndrome (CRPS) Types I and II, intractable low back pain and leg pain.

Z-2123-2020
Recall number
Z-2123-2020
Initiated
April 24, 2019
Classification
Class II
Status
Terminated
Quantity
2 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The firm is initiating a voluntary removal of certain spinal cord stimulation leads, lead extensions, adapters, and deep brain stimulation lead extensions due to "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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling Change Control

Compare all device evidence states

Inspect official wording and provenance

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 "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.

Code information

Part number M365SC9218150; serial numbers 1043743 and 1051329.

Distribution pattern

Distributed OUS only. to 14 countries.

device · product 6 of 7

Fifty-five (55) cm 8 Contact Extension Kit, part number M365SC3138550 - Product Usage: Lead Extensions are designed to connect the percutaneous leads to the Implantable Pulse Generator (IPG) for spinal cord stimulation. The extension may be added to a lead to externalize the lead for a trial procedure or to extend the lead when a permanent IPG is implanted. Package Contents: Lead Extension Kit (1) Lead Extension (1) Hex Wrench (1) Tunneling Tool Assembly (1) Device Registration Form/Temporary Patient Identification Card (1) Manual

Z-2124-2020
Recall number
Z-2124-2020
Initiated
April 24, 2019
Classification
Class II
Status
Terminated
Quantity
41 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling Change Control

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Part number M365SC3138550; serial numbers 1044463, 1066242, 3003060, 1044464, 1068589, 3006620, 1044466, 1068602, 3009041, 1061554, 1068606, 3009045, 1062766, 1068608, 3009050, 1062770, 1068611, 3010114, 1062787, 3001046, 3012781, 1063430, 3002547, 3013204, 1063632, 3002561, 3013267, 1063650, 3002817, 3018105, 1063749, 3003040, 3018106, 1063798, 3003042, 3018866, 1063801, 3003047, 3036973, 1066182, and 3003048.

Distribution pattern

Distributed OUS only. to 14 countries.

device · product 7 of 7

Fifty-five (55) cm 8 Contact Extension Kit, part number M365NM3138550 - Product Usage: The Deep Brain Stimulation (DBS) System is indicated for use in bilateral stimulation of the subthalamic nucleus (STN) as an adjunctive therapy in reducing some of the symptoms of moderate to advanced levodopa-responsive Parkinson s disease (PD) that are not adequately controlled with medication.

Z-2125-2020
Recall number
Z-2125-2020
Initiated
April 24, 2019
Classification
Class II
Status
Terminated
Quantity
8 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling Change Control

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Part number M365NM3138550; serial numbers 1049357, 1057232, 3014616, 1053194, 3010769, 3014631, 1057225 and 3012324.

Distribution pattern

Distributed OUS only. to 14 countries.