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FilterWire EZ™
BOSTON SCIENTIFIC CORPORATION · Model H749390711900 · UDI-DI 08714729808800
NFA
Prescription
10
510(k) clearances
2,035
Adverse events (38 deaths)
4
Recalls
7
Facilities
Description
Embolic Protection System
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2006-05-24 | Kensey Nash Corp | Volume control knob not able to go up to larger diameters |
| 2006-05-24 | Kensey Nash Corp | volume control knob not able to go up to larger diameters |
| 2006-05-24 | Kensey Nash Corp | volume control knob not able to go up to larger diameters |
| 2006-04-06 | Kensey Nash Corp | Alarm activiation-A priming issue involving the flow control unit due to a software problem has caused false postive Extraction Line Block (ELB) alarming. Use of this product may |
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