Nalu TD2 Therapy Disc with firmware, REF: 34014-001, and TD2 Patient Kit, REF: 74011, part of the Nalu Neurostimulation System
Boston Scientific Neuromodulation Corporation · Therapy Disc (TD) that powers and sends stimulation signals to an Implantable Pulse Generator (IPG), part of a neurostimulation system, has a firmware issue th…
Open FDA's page for this record- Cfres ID
- 222482
- Product res number
- Z-0311-2027
- Event date initiated
- 2026-09-30
- Event date posted
- 2026-10-29
- Recall status
- Open, Classified
- Res event number
- 99785
- Product code
- GZB
- Product description
- Nalu TD2 Therapy Disc with firmware, REF: 34014-001, and TD2 Patient Kit, REF: 74011, part of the Nalu Neurostimulation System
- Firm FEI number
- 3006630150
- Recalling firm
- Boston Scientific Neuromodulation Corporation
- Address 1
- 25155 Rye Canyon Loop
- City
- Valencia
- State
- CA
- Postal code
- 91355-5004
- Additional info contact
- Renee Archie 508-683-4523
- Root cause description
- Software change control
- Product quantity
- 134
- Distribution pattern
- US Nationwide distribution in the states of PA, FL, OR, AZ, OH, SC, TX, OR, OK, MI, CA, NJ.
- Code info
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
- Reason for recall
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.
- Action
On 9/30/2026, correction notices will be sent to healthcare professionals informing them of the following: Patients are provided with two TDs at the time of therapy activation, so therapy can be restored with the use of an alternate TD. The firm is asking healthcare professionals to do the following: 1) Identify the affected patients and inform them of this recall to arrange an-field TD firmware update. All affected units should be updated with the new firmware. Patient letter is provided with this notification for your use. 2) Contact the local firm representative to arrange an in-field TD firmware update at your facility. Append the patient's medical record accordingly when the firmware update is completed. 3) Share this communication with any healthcare professionals in your facility that use the product and with any other organization to which these systems may have been transferred. 4) Complete and return the Acknowledgement Form via email to BSCFieldActionCenter@bsci.com The patient notice recommended that patients contact their physician's office so they can arrange an in-field TD firmware update with the local firm representative. If they have any questions after contacting their doctor, contact the firm's Patient Care at 800-618-3402 or BSNPatientCare@bsci.com. Report any adverse events or quality concerns associated with use of these devices to the firm via email at BSCComplaints@bsci.com
- K numbers
- K233801
- Harmonized identifiers (openFDA)
- Device name
- Stimulator, Spinal-Cord, Implanted (Pain Relief)
- Medical specialty description
- Neurology
- Regulation number
- 882.5880
- Device class
- 2
- K number
- K130545, K960728, K883780, K892884, K201618, K062041, K113611, K160600, K033016, K844115, K945103, K884948, K972906, K812155, K991784, K801384, K901499, K954886, K934065, K921319, K990469, K932202, K833809, K170141, K010008, K932948, K881491, K221376, K831746, K032561, K855107, K913993, K812154, K930242, K203547, K862915, K013120, K172644, K941342, K070847 +99 more
- Registration number
- 3018094310, 2649622, 2030624, 3015924373, 3009166798, 2032521, 3008255748, 3006705815, 2183744, 3004593495, 2182207, 3010676138, 1627487, 3019807891, 3015425075, 3016547665, 1928237, 3022631685, 3013023969, 2246552, 1035166, 3009183442, 2135338, 2124215, 2024311, 3006630150, 3005160949, 3010531069, 3002672225, 3008988055, 1422634, 3004209178, 2031093
- FEI number
- 3018094310, 2649622, 3015924373, 3005700659, 3004369318, 3009166798, 3008255748, 3006705815, 2183744, 3004593495, 1000514656, 2182207, 3010676138, 1627487, 3019807891, 3015425075, 3016547665, 1928237, 3022631685, 3013023969, 2246552, 1035166, 3003574398, 3009183442, 2124215, 2024311, 3006630150, 3005160949, 3010531069, 3000206435, 3002672225, 3008988055, 3001236549