Boston Scientific recalls WAVEWRITER ALPHA spinal cord stimulation devices with specific model numbers due to potential temporary loss of therapy causing discomfort and possible surgical intervention requests. Affected units have unique reference codes and serial numbers.
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.
Boston Scientific is recalling specific models of spinal cord stimulation devices that may temporarily stop therapy for 10-15 seconds during charging. This could cause discomfort and lead patients to request surgery if they experience the interruption frequently.
The device may reset during normal charging cycles, causing temporary loss of therapy for 10-15 seconds. This interruption can cause discomfort and may lead patients to request surgical intervention if the issue occurs repeatedly.
Patients with spinal cord stimulation devices using the recalled WAVEWRITER ALPHA models are most at risk. These devices are used for chronic pain management and may require regular adjustments.
Check for model numbers SC-1216 (16 IPG Kit) or SC-1232 (32 IPG Kit) with reference codes M365SC12160 or M365SC12320. The serial numbers range from 8714729985082 to 758920 for the first model and 8714729985099 to 759404 for the second.
Identify if your device is model SC-1216 or SC-1232 with the specified reference codes.
Reach out to Boston Scientific for guidance on device status and potential remedies.
The recall is due to potential temporary loss of therapy during charging cycles, which may cause discomfort and lead to surgical intervention requests.
The device may temporarily stop therapy for 10-15 seconds during charging cycles.
No, but patients should contact Boston Scientific to confirm if their device is affected and follow their guidance.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-2617-2024 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-2617-2024 from Boston Scientific. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
