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Novo Surgical
NOVO SURGICAL, INC. · Model 5093-72 · UDI-DI 00842331118975
FHN
Prescription
10
510(k) clearances
2,058
Adverse events (8 deaths)
5
Recalls
89
Facilities
Description
loading cone only, used with mcgivney hemorrhoidal ligator
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2011-07-19 | Boston Scientific Corporation | Boston Scientific has received reports where, following clip deployment, the alignment of the clip and delivery system does not allow for the withdrawal of the delivery system away |
| 2010-09-03 | Cook Endoscopy | A section of the ligator barrel may separate from the barrels friction fit adapter that attaches to the patent end of the endoscope. This could result in a section of the ligator b |
| 2009-06-17 | Boston Scientific Corporation | The clip may not deploy or, if deployed, the clip may not release from the tissue. |
| 2009-06-17 | Boston Scientific Corporation | The clip may not deploy or, if deployed, the clip may not release from the tissue. |
| 2004-01-15 | Wilson-Cook Medical Inc | Product label lacks the symbols specifying the meaning of the manufacturing and expiration date. |
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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.