FDA Device recall Z-2485-2025
Superion IDS Kit Superion Indirect Decompression System 8MM, VF Implant 101-9808 00884662000529 Superion Indirect Decompression System 10MM…
- FDA Device
- Class II
- ongoing
- Published 2025-09-10
On 2025-09-10 the FDA classified a Class II recall of Superion IDS Kit Superion Indirect Decompression System 8MM, VF Implant 101-9808 00884662000529 Superion Indirect Decompression System 10MM… by Boston Scientific Neuromodulation, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2485-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-06-06 |
| Published | 2025-09-10 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Boston Scientific Neuromodulation |
| Distribution | US |
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.
Identifiers
| code_info | Superion Indirect Decompression System 8MM, VF Implant 101-9808 00884662000529 ALL Lot/Batch Number: 40280174 40145632…Superion Indirect Decompression System 8MM, VF Implant 101-9808 00884662000529 ALL Lot/Batch Number: 40280174 40145632 40117221 40113198 40113255 40113385 40113391 40113482 40106856 40027385 26176977 800276 800301 Superion Indirect Decompression System 10MM, VF Implant 101-9810 00884662000536 ALL Lot/Batch Numbers: 40222297 40213592 40199967 40198809 40195249 40186649 40181505 40166300 40157622 40141657 40141770 40136859 40131798 40132036 40112806 40106870 40093564 40080016 40080111 40076497 40070306 40070307 40052009 40045101 40034339 40027338 40027364 40022398 40018296 40018338 40010128 40004038 40004068 40000647 30244690 30178729 29985230 29849515 29849969 29668712 29668713 29578948 29578949 29360265 29360263 29360264 29160559 29160625 28756501 28627193 28627192 28627194 28501592 28501591 28501593 28344375 28344376 28344377 28133122 800279 800345 800269 800278 800268 800280 800261 800270 700089 800259 800260 800258 800250 800317 800318 700085 Superion Indirect Decompression System |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2485-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.