Z-2617-2024Class II

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

Name: Z-2617-2024 WAVEWRITER ALPHA: Model: SC-1216, 16 IPG KIT, REF: M365SC12160; Model: SC-1232, 32 IPG KIT, REF: M365SC12320
Creator: Boston Scientific Neuromodulation Corporation
Published: 2024-07-17
License: https://open.fda.gov/license/

Boston Scientific Neuromodulation Corporation / initiated 2024-07-17 / Open, Classified / root cause: software

FDA source

Boston Scientific Neuromodulation Corporation began a recall of WAVEWRITER ALPHA: Model: SC-1216, 16 IPG KIT, REF: M365SC12160; Model: SC-1232, 32 IPG KIT, REF: M365SC12320 on 2024-07-17. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-2617-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-07-17
Posted: 2024-08-14
Recalling firm: Boston Scientific Neuromodulation Corporation
Product: WAVEWRITER ALPHA: Model: SC-1216, 16 IPG KIT, REF: M365SC12160; Model: SC-1232, 32 IPG KIT, REF: M365SC12320
Product code: LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
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.
Root cause tag: software
FDA root cause: Software design
Action: 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 [email protected] Any adverse events or quality concerns associated with use of this product should be reported to the firm via email at [email protected] 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: [email protected].
Quantity in commerce: 77,674
Distribution: Worldwide Distribution: US (nationwide) including states of: TN, PA, WA, SC, MN, OH, NC, AK, NY, IL, CA, NJ, KY, IA, MO, UT, FL, IN, LA, AL, MS, MD, WI, GA, VA, TX, AZ, KS, OR, CO, CT, ID, AR, OK, MA, MI, ND, NE, SD, WV, NV, HI, NH, DC, MT, ME, VT, WY, DE, NM. OUS (foreign) countries of: Canada, Algeria, Austria, Azerbaijan, Belgium, Bulgaria, Croatia, Czech Republic, Denmark, Finland, France, Germany, Great Britain, Greece, Hungary, Ireland, Israel, Italy, Lebanon, Luxembourg, Netherlands, Norway, Poland, Qatar, Saudi Arabia, Slovakia, Spain, Sweden, Switzerland, Turkey, Ukraine, United Arab Emirates, Portugal, Japan, Australia, New Zealand, Singapore, Argentina, Brazil, Colombia, Puerto Rico
Product codes and lots: REF/UDI-DI(GTIN)/Serial Number Range/Expiration Date Range: M365SC12160/8714729985082/100188 - 758920, M365SC12320/8714729985099/100635 - 759404

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2617-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2617-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-08-21	2024-08-14

Product code LGW

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)