Boston Scientific Nalu TD2 therapy disc recalled over firmware failure
Boston Scientific is recalling certain Nalu TD2 Therapy Discs and TD2 Patient Kits used with the Nalu Neurostimulation System. A firmware problem can cause the disc to try to restart and then fail, so it stops working. If no backup disc is available, the implanted pulse generator may also stop working, which could leave pain signals unblocked. No injuries have been reported.
From the FDA notice · Read the official notice ↗ · All Boston Scientific recalls
What to do
- Check whether your Therapy Disc or TD2 Patient Kit matches the REF and serial numbers listed in the recall.
- Contact your doctor or Boston Scientific for guidance before changing how you use your device.
- If your stimulation stops and your pain returns, contact your care team right away.
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- Nalu TD2 Therapy Disc with firmware, REF: 34014-001, and TD2 Patient Kit, REF: 74011, part of the Nalu Neurostimulation System
- Sold in
- Nationwide
- Made for
- Adults (18 years to 100 years)
Details
- Units affected
- 134
- Illnesses reported
- None reported
- Manufactured in
- 25155 Rye Canyon Loop, Valencia, California, United States
- Classification
- Class II
- Recall number
- Z-0311-2027
In the FDA's words
- Description
- Nalu TD2 Therapy Disc with firmware, REF: 34014-001, and TD2 Patient Kit, REF: 74011, part of the Nalu Neurostimulation System Therapy Disc (TD) that powers and sends stimulation signals to an Implantable Pulse Generator (IPG), part of a neurostimulation system, has a firmware issue that causes the TD to attempt to restart, then fail, leading it to become non-functional, and if a secondary TD is unavailable, this may lead IPG to become non-functional, thus unable to inhibit transmission of pain signals. Firmware versions v2.0.71 and v2.0.77 REF/UDI-DI/Serial Numbers: 34014-001/00812537037134/ 100855, 100877, 100883, 100884, 100886, 100888, 100898, 100903, 100908, 100911, 100916, 100932, 101103, 100902; 74011/00812537037127, 00812537036977/101439, 100913, 100949, 101159, 101162, 101163, 101164, 101173, 101175, 101177, 101186, 101187, 101188, 101189, 101192, 101200, 101205, 101208, 101213, 101214, 101218, 101219, 101221, 101222, 101240, 101245, 101247, 101249, 101256, 101257, 101259, 101260, 101261, 101264, 101267, 101268, 101270, 101272, 101273, 101277, 101278, 101280, 101283, 101284, 101290, 101297, 101298, 101301, 101305, 101307, 101310, 101311, 101312, 101314, 101315, 101326, 101330, 101331, 101334, 101338, 101344, 101345, 101346, 101356, 101357, 101358, 101359, 101363, 101364, 101367, 101375, 101376, 101377, 101378, 101381, 101383, 101387, 101388, 101392, 101400, 101405, 101408, 101410, 101414, 101415, 101417, 101418, 101419, 101429, 101431, 101432, 101436, 101440, 101441, 101443, 101447, 101448, 101450, 101451, 101466, 101490, 101493, 101504, 101510, 101511, 101514, 101520, 101527, 101528, 101534, 101535, 101553, 101557, 101567, 101571, 101576, 101599, 101617, 101623, 101656 Distribution: US Nationwide distribution in the states of PA, FL, OR, AZ, OH, SC, TX, OR, OK, MI, CA, NJ. Affected quantity: 134
- Hazard
- Therapy Disc (TD) that powers and sends stimulation signals to an Implantable Pulse Generator (IPG), part of a neurostimulation system, has a firmware issue that causes the TD to attempt to restart, then fail, leading it to become non-functional, and if a secondary TD is unavailable, this may lead IPG to become non-functional, thus unable to inhibit transmission of pain signals.