ELCA™ 117-016AARecalls & reported problems
Spectranetics Corporation · ELCA™ Coronary Laser Atherectomy Catheter · Class 3
Data updated Oct 13, 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 00813132020057), received between Apr 8, 2020 and Apr 8, 2020 — classified as 1 injury.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).
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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Detachment of Device or Device Component1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryApr 8, 2020Detachment of Device or Device Component; Detachment of Device or Device Component
A CORONARY VASCULAR INTERVENTION PROCEDURE COMMENCED TO TREAT IN STENT RESTENOSIS (ISR) WITHIN THE PATIENT'S PROXIMAL CIRCUMFLEX ARTERY. THE PHYSICIAN CHOSE A 1.7F SPECTRANETICS ELCA CORONARY ATHERECTOMY CATHETER TO TREAT THE PATIENT. DURING THE PROCEDURE, THE DEVICE'S DISTAL MARKER BAND DETACHED WITHIN THE CORONARY ARTERY. THE PHYSICIAN WAS ABLE TO INFLATE A BALLOON, RETRIEVED THE MARKER BAND AND REMOVED IT FROM THE BODY. THERE WAS NO HARM REPORTED TO THE PATIENT. THE MANUFACTURER HAS BEEN INFORMED THE DEVICE IS BEING RETURNED FOR EVALUATION; HOWEVER IT HAS NOT BEEN RECEIVED AT THIS TIME. DUE TO COVID-19 CRISIS, THE DEVICE RETURN MAY BE SIGNIFICANTLY DELAYED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9935985 ↗
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™ 117-205ABSpectranetics 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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