Recall Z-2485-2025— Boston Scientific Neuromodulation Corporation

Class II FDA medical device recall by Boston Scientific Neuromodulation Corporation, initiated 2025-06-06. FDA's recall record names no specific 510(k) clearance for this event. 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: 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..

Recalling firm

Boston Scientific Neuromodulation Corporation

Classification

Class II

Status

Ongoing

Initiated

2025-06-06

Firm location

Valencia, CA, United States

Data sourced from openFDA. This site is unofficial and independent of the FDA.