FDA Device recall Z-1972-2023
Driver Instrument, part of the Superion Indirect Decompression System, REF: 102-9800, used with the Superion Indirect Decompression System…
- FDA Device
- Class II
- ongoing
- Published 2023-06-21
On 2023-06-21 the FDA classified a Class II recall of Driver Instrument, part of the Superion Indirect Decompression System, REF: 102-9800, used with the Superion Indirect Decompression System… by Boston Scientific Neuromodulation, citing pending update to indirect decompression system instructions for use informing users that excessive force during the implant procedure may cause driver instrument tip breaks, whic….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1972-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-05-12 |
| Published | 2023-06-21 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Boston Scientific Neuromodulation |
| Distribution | US |
Product
Driver Instrument, part of the Superion Indirect Decompression System, REF: 102-9800, used with the Superion Indirect Decompression System IFU, Superion IDS Kit IFU, Surgical Technique Manual
Reason
Pending update to indirect decompression system instructions for use informing users that excessive force during the implant procedure may cause driver instrument tip breaks, which may result in metal fragments (Driver teeth/tips) within the implant location; and if metal fragments are not removed and remain in situ, MRI scans are NOT advised due to potential risk of patient injury.
Identifiers
| code_info | Driver UDI-DI: 00884662000574, UPN: 102-9800, All Lots. Superion Indirect Decompression System IFU (92479815-02), Supe…Driver UDI-DI: 00884662000574, UPN: 102-9800, All Lots. Superion Indirect Decompression System IFU (92479815-02), Superion IDS Kit IFU (92479820-02), Surgical Technique Manual (92479821-02) |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1972-2023%22
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