Spinal Cord Stimulation Devices May Reset During Charging, Causing Transient Therapy Loss
Boston Scientific spinal cord stimulation implants may reset during routine charging, causing brief loss of therapy. Patients may experience undesired sensations when stimulation restarts, potentially leading to surgical intervention requests.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II medical device recall affecting an implanted therapeutic device with potential for transient loss of critical function. Although no injuries or hospitalizations have been reported, the hazard poses a risk of patient discomfort and potential unnecessary surgical intervention. Per the rubric, this qualifies as a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Boston Scientific Neuromodulation Corporation is recalling WAVEWRITER ALPHA spinal cord stimulation implantable pulse generators (Models SC-1216 and SC-1232). The devices may experience an unintended reset during routine system checks while charging, causing a transient loss of stimulation for approximately 10-15 seconds.
When stimulation therapy resumes after the reset, patients may experience undesired sensations. These unexpected sensations may prompt some patients to request surgical intervention for device replacement or revision, despite the stimulation loss being temporary.
Approximately 77,674 affected units have been distributed worldwide, including throughout the United States. Patients with implanted WAVEWRITER ALPHA devices should contact their healthcare provider or Boston Scientific with any questions or concerns about their device.
The recalled product
- Product
- WAVEWRITER ALPHA: Model: SC-1216, 16 IPG KIT, REF: M365SC12160; Model: SC-1232, 32 IPG KIT, REF: M365SC12320
- Manufacturer
- Boston Scientific Neuromodulation Corporation
- Hazard
- device-reset
- therapy-loss
- undesired-sensations
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- M365SC12320/8714729985099/100635 - 759404
Distribution
Distributed nationwide across the United States.
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