Boston Scientific Neuromodulation Corporation recalls Superion IDS Kit Superion Indirect Decompression System 8MM, VF Implant 101-9808 00884662000529 Superion Indirect Decom…

Recall date

June 6, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2485-2025

FDA classification

Class II

Brand / firm

Boston Scientific Neuromodulation Corporation

Sold / distributed

U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.