Wavewriter Alpha recall
WAVEWRITER ALPHA: Model: SC-1216, 16 IPG KIT, REF: M365SC12160; Model: SC-1232, 32 IPG KIT, REF: M365SC12320
Why was Wavewriter Alpha 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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
REF/UDI-DI(GTIN)/Serial Number Range/Expiration Date Range: M365SC12160/8714729985082/100188 - 758920, M365SC12320/8714729985099/100635 - 759404
- Product
- WAVEWRITER ALPHA: Model: SC-1216, 16 IPG KIT, REF: M365SC12160; Model: SC-1232, 32 IPG KIT, REF: M365SC12320
- Recalling firm
- Boston Scientific Neuromodulation Corporation
- Quantity
- 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
- Recall date
- August 21, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)