Superion¿ Indirect Decompression System — Class II medical device recall Z-0230-2023
Ongoing recall by Boston Scientific Neuromodulation Corporation, reported 2022-11-23, distributed nationwide. Due to Indirect Decompression System devices exhibiting a potential for weld breakage at the spindle cap-to-ma
| Recall number | Z-0230-2023 |
|---|---|
| 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 | 2022-10-12 |
| Classified | 2022-11-13 |
| Reported by FDA | 2022-11-23 |
| Distributed | Nationwide (US) |
| Quantity | 175 devices |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 00884662000529, 00884662000543, 00884662000550 |
| Lot numbers | 26176977, 26323984, 26366842, 26375758, 26406210, 26489700, 26573432, 26619510, 26654632, 26799951, 26807662, 26815560, 26848047, 26928168, 26929605 |
| Model numbers | 00884662000529, 00884662000543, 00884662000550, 101-9808, 101-9812, 101-9814, 26176977, 26323984, 26366842, 26375758, 26406210, 26489700, 26573432, 26619510, 26654632, 26799951, 26807662, 26815560, 26848047, 26928168, 26929605 |
Product
Superion¿ Indirect Decompression System (IDS) Model Numbers and Size: 101-9808 - 8mm 01-9812 - 12mm 101-9814 - 14mm
Reason for recall
Due to Indirect Decompression System devices exhibiting a potential for weld breakage at the spindle cap-to-main body interface. As a result of the separation of the spindle cap from the main body it may prevent proper deployment of the device during implantation.
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-0230-2023. 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.