WAVEWRITER ALPHA: Model: SC-1216 — Class II medical device recall Z-2617-2024

Ongoing recall by Boston Scientific Neuromodulation Corporation, reported 2024-08-21, distributed nationwide. Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG) may experience routine system check during IPG

Recall number	`Z-2617-2024`
Product type	Medical device
Classification	Class II
Status	Ongoing
Voluntary or mandated	Voluntary
Recalling firm	Boston Scientific Neuromodulation Corporation, Valencia, CA, United States
Recall initiated	2024-07-17
Classified	2024-08-14
Reported by FDA	2024-08-21
Distributed	Nationwide (US)
Countries outside the US	AE, AR, AT, AU, BE, BG, BR, CA, CH, CO, CZ, DE, DK, DZ, ES, FI, FR, GB, GR, HR, HU, IE, IL, IT, JP, LB, LU, NL, NO, NZ, PL, PT, QA, SA, SE, SG, SK, TR, UA
Quantity	77,674
UPC / GTIN / UDI-DI	`08714729985082`, `08714729985099`
Model numbers	`M365SC12160`, `M365SC12320`, `SC-1216`, `SC-1232`

Product

WAVEWRITER ALPHA: Model: SC-1216, 16 IPG KIT, REF: M365SC12160; Model: SC-1232, 32 IPG KIT, REF: M365SC12320

Reason for recall

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.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2617-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.