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Superion Dilator 2
VERTIFLEX, INC. · Model N/A · UDI-DI 00884662000338
NQO
Prescription
0
510(k) clearances
2,908
Adverse events (5 deaths)
6
Recalls
21
Facilities
Description
Superion Dilator 2
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-06-06 | Boston Scientific Neuromodulation Corporation | 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 |
| 2023-05-12 | Boston Scientific Neuromodulation Corporation | Pending update to indirect decompression system instructions for use informing users that excessive force during the implant procedure may cause driver instrument tip breaks, which |
| 2022-10-12 | Boston Scientific Neuromodulation Corporation | Due to Indirect Decompression System devices exhibiting a potential for weld breakage at the spindle cap-to-main body interface. As a result of the separation of the spindle cap f |
| 2008-12-08 | Theragenics Corporation | Some pouches were found to have weak seals potentially compromising sterility. |
| 2008-01-30 | Kyphon Inc | Physician instructions revised due to product breakage: During the implantation of the X-STOP IPD Device, the product has the potential to cause damage to and/or breakage of the X |
| 2006-06-06 | St. Francis Medical Technologies Inc | Some units may be mislabeled as 10 mm X STOP implant that actually contain 14 mm X STOP implant. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.