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SpiderFX
Covidien LP · Model SPD2-US-030-320 · UDI-DI 00821684040331
NFA
Prescription
1
510(k) clearances
2,032
Adverse events (38 deaths)
4
Recalls
7
Facilities
Description
Embolic Protection Device
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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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.