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ELCA™
Spectranetics Corporation · Model 110-001AA · UDI-DI 00813132020002
LPC
Prescription
0
510(k) clearances
298
Adverse events (35 deaths)
4
Recalls
3
Facilities
Description
ELCA™ Coronary Laser Atherectomy Catheter
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2022-10-14 | Spectranetics Corporation | Laser System may detect Error 106 or Error 108 System Failures that will cause the system to enter non-recoverable safe state. The user will not be able to proceed until the error |
| 2022-06-01 | Spectranetics Corporation | The LAS-100 Laser system may detect an inoperable hardware component during power up, which results in an error code and the system not being operable until code is cleared. |
| 2016-10-31 | Spectranetics Corporation | Spectranetics Corporation announces a voluntary field action for the Turbo Elite Atherectomy Catheter, ELCA Coronary Atherectomy Catheter, and Bridge Occlusion Balloon due to poten |
| 2012-03-13 | Spectranetics Corp. | Isolated lots of the 12Fr SLS II Laser Sheath can have a split in the outer jacket. |
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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.