WAVEWRITER ALPHA: Model: SC-1216, 16 IPG KIT, REF: M365SC... (Boston Scientific Neuromodulation Corporation) – spinal cord stimulation (scs) implant... (2024)
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
WAVEWRITER ALPHA: Model: SC-1216, 16 IPG KIT, REF: M365SC12160; Model: SC-1232, 32 IPG KIT, REF: M365SC12320
Brand
Boston Scientific Neuromodulation Corporation
Lot Codes / Batch Numbers
M365SC12320/8714729985099/100635 - 759404
Products Sold
REF/UDI-DI(GTIN)/Serial Number Range/Expiration Date Range: M365SC12160/8714729985082/100188 - 758920, M365SC12320/8714729985099/100635 - 759404
Boston Scientific Neuromodulation Corporation is recalling WAVEWRITER ALPHA: Model: SC-1216, 16 IPG KIT, REF: M365SC12160; Model: SC-1232, 32 IPG KIT, REF: M36 due to Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG) may experience routine system check during IPG charging, which may cause device reset,. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
On 7/17/24, "URGENT MEDICAL DEVICE ADVISORY" Notices were sent to Physicians/Surgeons, Hospitals, Healthcare Professionals informing them of the following: 1) Review any patient reports of undesired sensations indicative of potential device reset behavior during IPG charging and report these observations to Boston Scientific. 2) An in-field IPG firmware update is available for the patient s device. This will eliminate the possibility of a coincident routine device system check during IPG charging, thus preventing a potential system reset. Append the patients medical record accordingly if a firmware update is completed. 3) Patient letter is enclosed with this communication. This letter is provided for sharing with your patient and/or to be included within the patient s medical record. The patient letter can also be accessed on the Boston Scientific Product Advisories page via this link: www.bostonscientific.com/en-US/pprc/product-advisories.html 4) Post this information in a visible location near the product(s) to ensure information is easily accessible to all users. 5) Distributor customers should notify all customers that have been shipped/sold affected product about the correction. 6) Complete and return the acknowledgement form to BSCFieldActionCenter@bsci.com Any adverse events or quality concerns associated with use of this product should be reported to the firm via email at BSN.ComplaintCallCenter@bsci.com The patient letter advises the following: discuss this letter and the device software update with your doctor and continue to follow their instructions. If you have any additional questions after contacting your doctor, please contact the firm's Support at 1-833-327-8324 (Option 2) or email to: bsn.tech.support@bsci.com.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026