OFFICIAL-SOURCE RECALL · AUSTRALIA
WaveWriter Alpha Spinal Cord Stimulation (SCS) System Recall: Classification Class III Reason for the Action
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- Brand
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- Product
- WaveWriter Alpha Spinal Cord Stimulation (SCS) System
- Manufacturer
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- Date code
- dates
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The barcode may identify the product type, while the recall may apply only to certain lots, dates or variants. Check all identifiers listed in the official recall.
Why this product was recalled
Classification Class III Reason for the Action Boston Scientific is notifying customers of an update to the Information for Prescribers and Information for Patients manuals used in Australia for applicable Boston Scientific WaveWriter Alpha Spinal Cord Stimulation (SCS) System implantable components. Following a review by the Therapeutic Goods Administration (TGA), Boston Scientific is updating SCS System labelling containing device lifetime statements to clarify that the clinical performance and safety of the implantable components have been demonstrated for 3 years. Instructions for Customers/Users Customers are to: - Refer to the updated Information for Prescribers and Information for Patients manuals when they become available. Devices that have already been implanted do not require prophylactic replacement, additional patient follow-up, or any change in clinical management solely as a result of this notification. Action Commencement Date 5/08/2026 Responsible Entity Boston Scientific Pty Ltd
Hazard
Classification Class III Reason for the Action Boston Scientific is notifying customers of an update to the Information for Prescribers and Information for Patients manuals used in Australia for applicable Boston Scientific WaveWriter Alpha Spinal Cord Stimulation (SCS) System implantable components. Following a review by the Therapeutic Goods Administration (TGA), Boston Scientific is updating SCS System labelling containing device lifetime statements to clarify that the clinical performance and safety of the implantable components have been demonstrated for 3 years. Instructions for Customers/Users Customers are to: - Refer to the updated Information for Prescribers and Information for Patients manuals when they become available. Devices that have already been implanted do not require prophylactic replacement, additional patient follow-up, or any change in clinical management solely as a result of this notification. Action Commencement Date 5/08/2026 Responsible Entity Boston Scientific Pty Ltd
Official recall notice
WaveWriter Alpha Spinal Cord Stimulation (SCS) System
Agency: Therapeutic Goods Administration
Official publication date: August 5, 2026
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