Superion IDS Kit Superion Indirect Decompression System 8MM — Class II medical device recall Z-2485-2025

Ongoing recall by Boston Scientific Neuromodulation Corporation, reported 2025-09-10, distributed nationwide. As a result of a comprehensive product performance review it was determine that the device and instruments are

Recall number	`Z-2485-2025`
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	2025-06-06
Classified	2025-09-02
Reported by FDA	2025-09-10
Distributed	Nationwide (US)
Quantity	70,516
Reason classes	device malfunction
UPC / GTIN / UDI-DI	`00884662000529`, `00884662000536`, `00884662000543`, `00884662000550`, `00884662000567`, `00884662000574`, `00884662000611`
Lot numbers	`204019`, `204020`, `204025`, `204026`, `204032`, `204033`, `204044`, `204045`, `204052`, `204053`, `204066`, `204067`, `204083`, `204084`, `204085`, `204086`, `204094`, `204095`, `204103`, `204104`, `204105`, `204106`, `26169429`, `26170979`, `26176372`, `26176977`, `26177038`, `26177045`, `26177046`, `26177047`, `26177049`, `26177050`, `26177744`, `26178139`, `26178704`, `26267257`, `26284114`, `26284115`, `26284118`, `26284119` and 460 more

Product

Superion IDS Kit Superion Indirect Decompression System 8MM, VF Implant 101-9808 00884662000529 Superion Indirect Decompression System 10MM, VF Implant 101-9810 00884662000536 Superion Indirect Decompression System 12MM, VF Implant 101-9812 00884662000543 Superion Indirect Decompression System 14MM, VF Implant 101-9814 00884662000550 Superion Indirect Decompression System 16MM, VF Implant 101-9816 00884662000567 Superion Indirect Decompression System Kit, VF Instrument 102-9800 00884662000574 The Vertiflex Procedure Instrument Platform, VF Instrument 140-9800 00884662000611 The Superion IDS Kit includes a set of proprietary instruments to deliver the Superion Implant in a minimally invasive manner. Instruments specifically designed for implanting the Superion Implant are sterile, single-use disposable instruments, consisting of a Dilator Assembly, Cannula Assembly, Interspinous Gauge, Inserter, Reamer, and Driver.

Reason for recall

As a result of a comprehensive product performance review it was determine that the device and instruments are not consistently meeting expected performance levels. Issues include breakage of the instruments and implant/device.

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-2485-2025. 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.