Driver Instrument — Class II medical device recall Z-1972-2023
Ongoing recall by Boston Scientific Neuromodulation Corporation, reported 2023-06-21, distributed nationwide. Pending update to indirect decompression system instructions for use informing users that excessive force duri
| Recall number | Z-1972-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Boston Scientific Neuromodulation Corporation, Valencia, CA, United States |
| Recall initiated | 2023-05-12 |
| Classified | 2023-06-15 |
| Reported by FDA | 2023-06-21 |
| Distributed | Nationwide (US) |
| Quantity | 21,533 |
| Reason classes | foreign material |
| UPC / GTIN / UDI-DI | 00884662000574 |
| Model numbers | 102-9800 |
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 for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1972-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.