FDA Device recall Z-2617-2024
WAVEWRITER ALPHA: Model: SC-1216, 16 IPG KIT, REF: M365SC12160
- FDA Device
- Class II
- ongoing
- Published 2024-08-21
On 2024-08-21 the FDA classified a Class II recall of WAVEWRITER ALPHA: Model: SC-1216, 16 IPG KIT, REF: M365SC12160 by Boston Scientific Neuromodulation, citing spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG) may experience routine system check during IPG charging, which may cause device reset, which may lead to transient….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2617-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-07-17 |
| Published | 2024-08-21 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Boston Scientific Neuromodulation |
| Distribution | US |
Product
WAVEWRITER ALPHA: Model: SC-1216, 16 IPG KIT, REF: M365SC12160; Model: SC-1232, 32 IPG KIT, REF: M365SC12320
Reason
Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG) may experience routine system check during IPG charging, which may cause device reset, which may lead to transient loss of stimulation; patients may experience undesired sensations when therapy turns off for approx. 10-15 seconds and then back on, which may lead patient to request surgical intervention for replacement or revision.
Identifiers
| code_info | REF/UDI-DI(GTIN)/Serial Number Range/Expiration Date Range: M365SC12160/8714729985082/100188 - 758920, M365SC12320/8714729985099/100635 - 759404 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2617-2024%22
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