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Axios™
BOSTON SCIENTIFIC CORPORATION · Model M00553740 · UDI-DI 08714729904625
PCU
Prescription
10
510(k) clearances
2,138
Adverse events (65 deaths)
6
Recalls
7
Facilities
Description
Stent and Delivery System
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.