Official recall record
WAVEWRITER ALPHA: Model: SC-1216, 16 IPG KIT, REF: M365SC12160; Model: SC-1232, 32 IPG KIT, REF: M365SC12320
- Issuing authority
- US FDA — Medical Devices
- Alert date
- 2024-07-17
- Country of alert
- United States
- Alert level
- Class II
- Alert type
- recall
- Barcode (EAN/GTIN)
- 8714729985082
- Brand on record
- Boston Scientific Neuromodulation Corporation
- Product category
- Medical Device
What the authority reported
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.
What to do
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Verify at the source:
US FDA — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.
Record last checked against the registry on 2026-05-31.
Other recalls from this brand
- 2026-06-17 · US FDA — Medical Devices
INFINION CX LEAD KIT, 50CM, Model: SC-2317-50, Material: M365SC2317500; INFINION CX LEAD KIT, 70CM, Model: S - 2025-07-08 · US FDA — Medical Devices
Vercise Deep Brain Stimulation Systems Surgical Implant Manual, Document Number: 92328632-09 - 2025-07-08 · US FDA — Medical Devices
Burr Hole Cover Kit, REF: M365DB4600C0; Burr Hole Cover Spares Kit, REF: M365DB4605C0. Components of Vercise
ProductGuru Recalls republishes official safety information with attribution. We are not
the issuing authority and this page is not advice. If this product is a medical device or
medication, speak to a doctor or pharmacist. Found an error?
Report it — corrections are published.