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Artisan®
HANSEN MEDICAL, INC. · Model 06196 · UDI-DI 10815671020007
DXX
Prescription
10
510(k) clearances
86
Adverse events (7 deaths)
4
Recalls
6
Facilities
Description
Artisan Family Catheter Sterile Drape
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2016-03-25 | Hansen Medical Inc | Firm's quarterly dose audit testing showed that one batch was radiated below the augmented dose and therefore did not meet the augmented dose of 28.4 kGy. |
| 2015-03-18 | Hansen Medical Inc | Based on investigation of two complaint incidents, all Hansen Medical Magellan Robotic System (Model No. 11132 and 11139) may experience an unexpected event during a retraction ope |
| 2014-12-04 | Hansen Medical Inc | The Set Up Joint subassembly of the Sensei X Robotic Catheter System may become loose relative to the operating table with the potential for the device to fall causing, uncontrolle |
| 2009-10-19 | Hansen Medical Inc | Certain Artisan Extend Catheters may develop a leak in the flush assembly of the catheter which has the potential to cause flush fluid leakage and subsequent decrease in distal flu |
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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.