FDA Device recall Z-2122-2020
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…
- FDA Device
- Class II
- terminated
- Published 2020-06-03
On 2020-06-03 the FDA classified a Class II recall of 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… by Boston Scientific Neuromodulation, citing 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"….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2122-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-04-24 |
| Published | 2020-06-03 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Boston Scientific Neuromodulation |
| Distribution | n/a |
Product
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
Reason
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.
Identifiers
| code_info | Part number M365SC2352700; serial number 1042757. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2122-2020%22
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