FDA-Device2024-08-21Class II
WAVEWRITER ALPHA: Model: SC-1216, 16 IPG KIT, REF: M365SC12160; Model: SC-1232, 32 IPG KIT, REF: M365SC12320
Hazard
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.
Sold states
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
Affected count
77,674
Manufactured in
25155 Rye Canyon Loop, Valencia, CA, United States
Products
WAVEWRITER ALPHA: Model: SC-1216, 16 IPG KIT, REF: M365SC12160; Model: SC-1232, 32 IPG KIT, REF: M365SC12320
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2617-2024More Boston Scientific Neuromodulation Corporation recalls
- FDA-Device2026-06-17Boston Scientific CSK Electrodes recalled for substandard performance
- FDA-Device2026-06-17Boston Scientific Clik X Anchor recalled for sterility assurance concerns
- FDA-Device2026-06-17Boston Scientific TCN Electrodes recalled for substandard performance
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