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Niti-S SPAXUS Stent
TAEWOONGMEDICAL.CO.,LTD · Model SS1602FW · UDI-DI 08809909422300
1
510(k) clearances
2,148
Adverse events (65 deaths)
6
Recalls
7
Facilities
Description
The Niti-S SPAXUS Stent is a fully covered, self-expanding metallic stent.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2020-12-01 | Boston Scientific Corporation | The rotating luer fitting at the distal end of the delivery system handle may become detached from the nose of the delivery during device preparation, stent delivery or use, resul |
| 2020-12-01 | Boston Scientific Corporation | The rotating luer fitting at the distal end of the delivery system handle may become detached from the nose of the delivery during device preparation, stent delivery or use, resul |
| 2020-12-01 | Boston Scientific Corporation | The rotating luer fitting at the distal end of the delivery system handle may become detached from the nose of the delivery during device preparation, stent delivery or use, resul |
| 2020-12-01 | Boston Scientific Corporation | The rotating luer fitting at the distal end of the delivery system handle may become detached from the nose of the delivery during device preparation, stent delivery or use, resul |
| 2020-12-01 | Boston Scientific Corporation | The rotating luer fitting at the distal end of the delivery system handle may become detached from the nose of the delivery during device preparation, stent delivery or use, resul |
| 2020-12-01 | Boston Scientific Corporation | The rotating luer fitting at the distal end of the delivery system handle may become detached from the nose of the delivery during device preparation, stent delivery or use, resul |
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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.