ELCA™ 117-205ABRecalls & reported problems
Spectranetics Corporation · ELCA™ Coronary Laser Atherectomy Catheter · Class 3
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00813132025427), received between Feb 13, 2020 and Feb 13, 2020 — classified as 1 injury.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Cardiac Perforation1
- Iatrogenic Source1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryFeb 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A CORONARY INTERVENTION PROCEDURE COMMENCED TO TREAT AN IN-STENT RESTENOSIS (ISR) ON THE LEFT ANTERIOR DESCENDING CORONARY ARTERY (LAD), THE LEFT CIRCUMFLEX ARTERY (LCX) OPENING AND IN THE #13 ATRIOVENTRICULAR GROOVE OF THE LCX. SPECTRANETICS ECLA OS AND ELCA DEVICES WERE IN USE DURING THE PROCEDURE. WHILE USING THE ELCA DEVICE, A PERFORATION OCCURRED ON LCX #13. THEY TREATED THE INJURY USING A PERFUSION CATHETER AND A GRAFTMASTER. PATIENT WAS TRANSFERRED TO THE ICU AND SURVIVED. THERE WAS NO REPORTED MALFUNCTION OF THE SPECTRANETICS DEVICE USED IN THE PROCEDURE.
Patient problems: Cardiac Perforation; Iatrogenic Source
MAUDE report 9709065 ↗
Other Device, Angioplasty, Laser, Coronary devices
- Philips Laser System LAS-100Spectranetics Corporation · Device, Angioplasty, Laser, Coronary2 recalls9 reports
- ELCA Coronary Laser Atherectomy Catheter 110-004Spectranetics Corporation · Device, Angioplasty, Laser, Coronary2 deaths31 reports
- ELCA Coronary Laser Atherectomy Catheter 114-009Spectranetics Corporation · Device, Angioplasty, Laser, Coronary7 reports
- ELCA Coronary Laser Atherectomy Catheter 117-016Spectranetics Corporation · Device, Angioplasty, Laser, Coronary3 reports
- ELCA™ 110-004AASpectranetics Corporation · Device, Angioplasty, Laser, Coronary2 reports
- ELCA™ 114-009AASpectranetics Corporation · Device, Angioplasty, Laser, Coronary1 report
- ELCA Coronary Laser Atherectomy Catheter 110-002Spectranetics Corporation · Device, Angioplasty, Laser, Coronary1 death1 report
- ELCA™ 117-016AASpectranetics Corporation · Device, Angioplasty, Laser, Coronary1 report
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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