Reported Aug 21, 2024 · Ongoing
WAVEWRITER ALPHA: Model: SC-1216, 16 IPG KIT, REF: M365SC12160; Model: SC-1232, 32 IPG KIT, REF: M365SC12320
Boston Scientific Neuromodulation Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Boston Scientific Neuromodulation Corporation · 25155 Rye Canyon Loop · Valencia, CA · 91355-5004
Is this the product you have?
- WAVEWRITER ALPHA
Model: SC-121616 IPG KIT
- REFM365SC12160
- Model
SC-123232 IPG KIT
- REFM365SC12320
- Lot codes and dates
- REF/UDI-DI(GTIN)/Serial
- Number Range/Expiration Date Range
M365SC12160/8714729985082/100188 - 758920M365SC12320/8714729985099/100635 - 759404
- Amount recalled
- 77,674
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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