Reported Sep 10, 2025 · Ongoing
Superion IDS Kit Superion Indirect Decompression System 8MM, VF Implant
Boston Scientific Neuromodulation Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Boston Scientific Neuromodulation Corporation · 25155 Rye Canyon Loop · Valencia, CA · 91355-5004
Is this the product you have?
Superion IDS Kit Superion Indirect Decompression System 8MM, VF Implant
7 of 7 products
| Model / number | Barcodes | Product as published |
|---|---|---|
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. |
- Amount recalled
- 70,516
Where it was sold
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.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Boston Scientific Neuromodulation Corporation recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.