Recall Z-0311-2027 ยท GZB Stimulator, Spinal-Cord, Implanted (Pain Relief)
Boston Scientific Neuromodulation Corporation
Nalu TD2 Therapy Disc with firmware, REF: 34014-001, and TD2 Patient Kit, REF: 74011, part of the Nalu Neurostimulation System
| Date | Oct 29, 2026 (initiated Sep 30, 2026) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Software change control |
| 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 |
| Quantity | 134 |
| Distribution | US Nationwide distribution in the states of PA, FL, OR, AZ, OH, SC, TX, OR, OK, MI, CA, NJ. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K233801 | Nalu Neurostimulation System for Spinal Cord Stimulation; Nalu Neurostimulation System for Peripheral Nerve Stimulation Boston Scientific Neuromodulation, Aug 23, 2024 |