ELCA Coronary Laser Atherectomy CatheterRecalls & reported problems across all models

We found 4 models of ELCA Coronary Laser Atherectomy Catheter by Spectranetics Corporation in the FDA's device registry (GUDID). Together they are named in 42 adverse event reports in the FDA's MAUDE database, received between May 22, 2018 and Apr 29, 2026 — classified as 3 deaths, 14 injuries, 25 malfunctions.

The most frequently reported specific device problem is “Material Separation” (15 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported ELCA Coronary Laser Atherectomy Catheter problems

ELCA Coronary Laser Atherectomy Catheter models

4 models, most reported first. Each model has its own page with its reports, recalls and device details.

• ELCA Coronary Laser Atherectomy Catheter 110-004

  Device, Angioplasty, Laser, Coronary
  2 deaths31 reports
• ELCA Coronary Laser Atherectomy Catheter 114-009

  Device, Angioplasty, Laser, Coronary
  7 reports
• ELCA Coronary Laser Atherectomy Catheter 117-016

  Device, Angioplasty, Laser, Coronary
  3 reports
• ELCA Coronary Laser Atherectomy Catheter 110-002

  Device, Angioplasty, Laser, Coronary
  1 death1 report

Recent ELCA Coronary Laser Atherectomy Catheter adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionApr 29, 2026Material Separation

  A CORONARY ATHERECTOMY PROCEDURE COMMENCED TO TREAT A PATIENT WITH A SPECTRANETICS ELCA LASER ATHERECTOMY CATHETER. DURING USE, THE SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM DISPLAYED AN ERROR CODE WHEN INCREASING THE FLUENCY, AND THE CATHETER COULD NOT BE UTILIZED. AFTER RECALIBRATION AND RESTARTING THE LASER SYSTEM, THE SAME ISSUE OCCURRED. WHEN LOWERING THE PULSE AND FLUENCY, THE ELCA DEVICE PERFORMED WITHOUT FURTHER ISSUE, AND THE PROCEDURE WAS COMPLETED WITH NO REPORTED PATIENT HARM. UPON DEVICE EVALUATION ON 08APR2026, VISUAL INSPECTION FOUND BROKEN FIBERS AND MISSING EPOXY AT THE ELCA DISTAL TIP. THIS REPORT CAPTURES THE ELCA WITH MISSING MATERIAL; POTENTIAL FOR HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25029741 ↗
• MalfunctionMar 19, 2026Material Separation

  A CORONARY ATHERECTOMY PROCEDURE COMMENCED TO TREAT A PATIENT USING A SPECTRANETICS ECLA LASER ATHERECTOMY CATHETER. DURING A THIRD PASS ATTEMPT, THE FOOT PEDAL OF THE SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM WAS PRESSED; HOWEVER, THE ELCA WAS NOT WORKING. THE LASER SYSTEM WAS RESTARTED, THE ELCA WAS RE-CALIBRATED, BUT THE SAME ISSUE OCCURRED. THE ELCA WAS REMOVED, AND NEW ELCA WAS USED TO COMPLETE THE PROCEDURE WITH NO REPORTED PATIENT HARM. DURING EVALUATION ON 19FEB2026, VISUAL INSPECTION FOUND A BREACH TO THE WORKING LENGTH, WITH BROKEN FIBERS. MELTING OF THE OUTER JACKET WAS OBSERVED 4 MM FROM THE DISTAL TIP. CALIBRATION WAS NO POSSIBLE DUE TO THE BREACH AT THE WORKING LENGTH. THIS EVENT IS BEING REPORTED FOR UNINTENDED RADIATION EXPOSURE, POTENTIAL FOR HARM.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 24645888 ↗
• MalfunctionMar 19, 2026Material Separation

  A CORONARY ATHERECTOMY PROCEDURE COMMENCED TO TREAT A LESION IN THE LEFT ANTERIOR DESCENDING CORONARY ARTERY. A SPECTRANETICS ECLA LASER ATHERECTOMY CATHETER WAS BEING CALIBRATED; HOWEVER, CALIBRATION WAS UNSUCCESSFUL. THE PROCEDURE WAS COMPLETED WITHOUT THE USE OF THE ELCA, WITH NO REPORTED PATIENT HARM. DURING EVALUATION ON 19FEB2026, VISUAL INSPECTION FOUND A BREACH/PUNCTURE TO THE WORKING LENGTH, WITH A BROKEN FIBER VISIBLE. MELTING OF THE OUTER JACKET WAS OBSERVED 86 MM FROM THE DISTAL TIP. CALIBRATION WAS NOT POSSIBLE DUE TO THE BREACH AT THE WORKING LENGTH. THIS EVENT IS BEING REPORTED FOR UNINTENDED RADIATION EXPOSURE, POTENTIAL FOR HARM.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 24645863 ↗
• MalfunctionMar 12, 2026Material Separation

  A CORONARY ATHERECTOMY PROCEDURE COMMENCED TO TREAT A SEVERELY CALCIFIED LESION IN THE MID RIGHT CORONARY ARTERY (RCA). A SPECTRANETICS ELCA LASER ATHERECTOMY CATHETER, ALONG WITH A 0.014 GUIDEWIRE (MANUFACTURER UNKNOWN), TERUMO 6F INTRODUCER SHEATH, AND A CORDIS 6F GUIDE CATHETER, WERE USED TO TREAT THE PATIENT. DURING USE, LASER LIGHT WAS OBSERVED EMITTING NEAR THE PLUG. THE ELCA WAS REMOVED AND A NEW ELCA WAS USED TO COMPLETE THE PROCEDURE WITH NO REPORTED PATIENT HARM. THIS REPORT IS BEING SUBMITTED DUE TO UNINTENDED RADIATION EXPOSURE, POTENTIAL FOR HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unintended Radiation Exposure

  MAUDE report 24586029 ↗
• MalfunctionMar 6, 2026Material Separation

  A PERIPHERAL ATHERECTOMY PROCEDURE COMMENCED TO TREAT A MODERATELY CALCIFIED LESION. A SPECTRANETICS ELCA LASER ATHERECTOMY CATHETER WAS USED TO TREAT THE PATIENT. DURING USE, THE SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM DISPLAYED AN ERROR CODE, AND THE CATHETER COULD NOT BE UTILIZED. OTHER METHODS WERE USED TO COMPLETE THE PROCEDURE WITH NO REPORTED PATIENT HARM. UPON DEVICE EVALUATION ON 12FEB2026: VISUAL INSPECTION FOUND A SMALL BUMP, DEAD FIBERS, AND MISSING EPOXY AT THE ELCA DISTAL TIP. THIS REPORT CAPTURES THE ELCA WITH MISSING MATERIAL; POTENTIAL FOR HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24532741 ↗
• MalfunctionFeb 19, 2026Material Separation

  A PERIPHERAL ATHERECTOMY PROCEDURE COMMENCED TO TREAT A SEVERELY CALCIFIED LESION IN THE MID CIRCUMFLEX ARTERY. DURING USE OF A SPECTRANETICS ECLA LASER ATHERECTOMY CATHETER, WHEN REMOVING THE CATHETER FROM THE BODY, A ZIPPER TEAR WAS OBSERVED AT THE DISTAL END OF THE OUTER JACKET. THE CATHETER WAS REMOVED AND A BALLOON WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY REPORTED. THIS EVENT IS BEING REPORTED FOR UNINTENDED RADIATION EXPOSURE, POTENTIAL FOR HARM.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 24393144 ↗
• MalfunctionNov 18, 2025Entrapment of Device; Entrapment of Device

  A CORONARY ATHERECTOMY PROCEDURE COMMENCED TO TREAT A MODERATELY CALCIFIED LESION IN THE DISTAL RIGHT CORONARY ARTERY (RCA). A SPECTRANETICS ELCA LASER ATHERECTOMY CATHETER, ALONG WITH A NON-PHILIPS GUIDEWIRE AND GUIDE CATHETER WERE BEING USED TO TREAT THE PATIENT. DURING PULLBACK, IT WAS NOTED THAT THE ELCA WAS STUCK IN THE GUIDE CATHETER. THEREFORE, THE PHYSICIAN CUT THE ELCA AND GUIDEWIRE, AND REMOVED EVERYTHING TOGETHER, INCLUDING THE GUIDE CATHETER, KEEPING THE DISTAL PORTION OF THE GUIDEWIRE IN PLACE. TREATMENT WAS COMPLETED USING A BALLOON, WITH NO REPORTED PATIENT HARM. THIS REPORT IS BEING SUBMITTED DUE TO ENTRAPMENT, REQUIRING INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23583296 ↗
• MalfunctionNov 12, 2025Entrapment of Device; Entrapment of Device

  A CORONARY ATHERECTOMY PROCEDURE COMMENCED USING A SPECTRANETICS ELCA LASER ATHERECTOMY CATHETER TO TREAT THE PATIENT. DURING ADVANCEMENT TO THE LESION, THE CATHETER BECAME STUCK ON A NON-PHILIPS GUIDEWIRE; THEREFORE, REMOVED AS A SYSTEM. A NEW CATHETER WAS USED TO COMPLETE THE PROCEDURE WITH NO REPORTED PATIENT HARM. THIS REPORT IS BEING SUBMITTED DUE TO REMOVAL AS A SYSTEM. THERE IS POTENTIAL FOR HARM IF IT WERE TO RECUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23537737 ↗
• MalfunctionJul 28, 2025Activation, Positioning or Separation Problem

  FROM STAFF: SUCCESSFUL TAVR [TRANSCATHETER AORTIC VALVE REPLACEMENT] PROCEDURE, COMPLICATED BY VALVE EMBOLIZATION REQUIRING CONVERSION TO SURGICAL AVR [AORTIC VALVE REPLACEMENT] WITH PLACEMENT OF A NUMBER 23 EDWARDS SAPIEN INSPIRIS VALVE. FROM OPERATIVE REPORT: ESSENTIALLY THE VALVE DID NOT DEPLOY CORRECTLY INTO THE AORTIC ANNULUS AND SUBSEQUENTLY EMBOLIZED INTO THE LEFT VENTRICLE. WE IMMEDIATELY RECOGNIZED THIS AND CALLED FOR BACKUP SURGICAL ASSISTANCE, PERFUSION, AND ALL PREPARATION FOR STERNOTOMY CUT DOWN AND BAILOUT. PATIENT REMAINED HEMODYNAMICALLY STABLE DURING THIS TIME. WE ELECTED TO LEAVE THE SHEATH AND TAVR DEVICE IN THE CAROTID ARTERY WHICH WAS COVERED TO PREVENT DISLODGEMENT. WE MADE A STERNOTOMY INCISION AND THEN PROCEEDED TO OPEN THE PERICARDIUM. THE PATIENT'S ACT [ACTIVATED CLOTTING TIME] WAS NOTED TO BE OVER 400 SECONDS FROM PREVIOUSLY ADMINISTERED HEPARIN. GIVEN THE RELATIVE HEMODYNAMIC STABILITY WITH LOW PRESSOR REQUIREMENT, WE ELECTED TO PROCEED WITH CENTRAL CANNULATION RATHER THAN FEMORAL CANNULATION FOR CARDIOPULMONARY BYPASS. CONCENTRIC PURSE STRINGS WERE PLACED IN THE AORTA (AT AN AREA FREE OF CALCIFICATION AND PLAQUE) AND THE RIGHT ATRIUM AND CANNULAE WERE I

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22622868 ↗
• MalfunctionJun 24, 2025Off-Label Use; Material Separation; Off-Label Use; Material Separation

  A CORONARY ATHERECTOMY PROCEDURE COMMENCED TO TREAT A LESION IN THE RIGHT CORONARY ARTERY. A SPECTRANETICS ELCA CORONARY LASER ATHERECTOMY CATHETER WAS USED TO TREAT THE PATIENT VIA RADIAL ACCESS (OFF-LABEL USE). DURING USE, THE CATHETER COULD NOT BE RECOGNIZED AFTER INSERTION AND FAILED TO CALIBRATE. ANOTHER CATHETER WAS USED TO COMPLETE THE PROCEDURE WITH NO REPORTED PATIENT HARM. UPON DEVICE EVALUATION ON 29MAY2025, VISUAL INSPECTION FOUND THE INNER LUMEN WAS DEFORMED INWARD, AND THERE WAS MISSING AND BROKEN EPOXY, WITH CHIPPED FIBERS AT THE ELCA DISTAL TIP. THIS REPORT CAPTURES THE ELCA WITH MISSING MATERIAL, POTENTIAL FOR HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22318195 ↗
• InjuryMay 14, 2025Off-Label Use; Material Separation; Off-Label Use; Material Separation

  A CORONARY ATHERECTOMY PROCEDURE COMMENCED TO TREAT A PLAQUE LESION IN THE MID RIGHT CORONARY ARTERY (RCA). A SPECTRANETICS ELCA CORONARY LASER ATHERECTOMY CATHETER COMPLETED SEVERAL RUNS IN THE ARTERY WITH NO ISSUES. HOWEVER, THE DECISION WAS MADE TO LASE IN CONTRAST (OFF-LABEL USE), AND DURING THE LAST RUN, THE DISTAL MARKER BAND SEPARATED WITHIN THE PATIENT. A SNARE WAS USED TO ATTEMPT RETRIEVAL OF THE MARKER BAND, BUT UNSUCCESSFUL. THE TIP WAS FAR DOWN IN THE VESSEL, AND NO FURTHER ATTEMPTS TO REMOVE WERE MADE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED PATIENT HARM. THIS REPORT CAPTURES THE ELCA DISTAL MARKER BAND WHICH SEPARATED, REQUIRING INTERVENTION, BUT RETAINED IN PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 22018310 ↗
• MalfunctionApr 29, 2025Entrapment of Device; Entrapment of Device

  A CORONARY ATHERECTOMY PROCEDURE COMMENCED TO TREAT A SLIGHTLY CALCIFIED DISTAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. A SPECTRANETICS ELCA LASER ATHERECTOMY CATHETER WAS PLACED OVER A TERUMO 0.014 RUNTHROUGH GUIDEWIRE, AND INSERTED THROUGH A CORDIS 6F GUIDE CATHETER. DURING ADVANCEMENT, RESISTANCE WAS ENCOUNTERED INSIDE OF AN EXISTING STENT; HOWEVER, THE ELCA PROGRESSED UNTIL IT REACHED THE LAD LOCATED WITHIN ANOTHER STENT DISTALLY, AND ACTIVATED. RESISTANCE WAS ENCOUNTERED AGAIN; THEREFORE, FLUENCY AND RATE OF THE LASER CATHETER WAS INCREASED, WITHOUT SUCCESS. THE DECISION WAS THEN MADE TO ABANDON THE PROCEDURE, AND WHEN ATTEMPTING TO REMOVE THE ELCA, IT WOULD NOT RETREAT BACK INTO THE GUIDE CATHETER, EVEN AFTER SOME TROUBLE SHOOTING. THE ENTIRE SYSTEM WAS REMOVED FROM THE BODY, WHEN THE PATIENT EXPERIENCED ARM PAIN; AND WAS ADMINISTERED STANDARD MEDICATION TO RELIEVE THE PAIN. (PER PHILIPS CLINICAL ASSESSMENT, THE ARM PAIN IS NOT RELATED TO THE ELCA OR THE GUIDE WIRE, AND WAS LIKELY RELATED TO ARTERIAL SPASM AROUND THE GUIDE CATHETER.) OUTSIDE OF THE PATIENT, A PIECE OF PLASTIC WAS OBSERVED EXTENDING OUT FROM THE GUIDEWIRE EXIT PORT, ALONG WITH A DAMAGED GUIDEWIRE THAT WAS REMOV

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21931154 ↗
• InjuryApr 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CORONARY ATHERECTOMY PROCEDURE COMMENCED TO TREAT A PLAQUE LESION IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. MULTIPLE DEVICES (SPECTRANETICS ELCA CORONARY LASER ATHERECTOMY CATHETER, PHILIPS OMNIWIRE PRESSURE GUIDE WIRE, PHILIPS EAGLE EYE PLATINUM IVUS CATHETER, PHILIPS ANGIOSCULPT SCORING BALLOON CATHETER, TERUMO 0.014 RUNTHROUGH GUIDEWIRE, TERUMO 6F INTRODUCER SHEATH, AND MEDTRONIC 6F GUIDE CATHETER) WERE USED TO TREAT THE PATIENT. DURING USE OF THE ELCA CATHETER, A PERFORATION WAS NOTED IN THE LAD. RESCUE EFFORTS BEGAN IMMEDIATELY, INCLUDING AN ABBOTT GRAFTMASTER CORONARY STENT GRAFT SYSTEM, A BALLOON TO SEAL THE PERFORATION, AND SURGICAL TREATMENT. THE PATIENT SURVIVED THE PROCEDURE. THIS REPORT CAPTURES THE ELCA IN USE WHEN THE PERFORATION OCCURRED, REQUIRING INTERVENTION. THERE WAS NO ALLEGED MALFUNCTION OF ANY SPECTRANETICS DEVICES IN USE DURING THE PROCEDURE.

  Patient problems: Perforation of Vessels

  MAUDE report 21861246 ↗
• InjuryMar 11, 2025Off-Label Use; Adverse Event Without Identified Device or Use Problem; Off-Label Use; Adverse Event Without Identified Device or Use Problem

  THIS ADVERSE EVENT IS NO LONGER REPORTABLE BECAUSE THE PERFORATION WAS NOT DUE TO THE ELCA DEVICE; RATHER IT WAS A WIRE FROM A DIFFERENT MANUFACTURER.

  Patient problems: Perforation of Vessels

  MAUDE report 21576971 ↗
• MalfunctionJan 29, 2025Sharp Edges; Sharp Edges

  A CORONARY ATHERECTOMY PROCEDURE COMMENCED TO TREAT A PLAQUE IN THE RIGHT CORONARY ARTERY (RCA). A SPECTRANETICS ELCA CORONARY LASER ATHERECTOMY CATHETER WAS USED TO TREAT THE PATIENT. DURING USE, THE CATHETER GAVE AN ERROR TWO TO THREE SECONDS AFTER LASER EXPOSURE. A NEW CATHETER WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY REPORTED. UPON COMPLETION OF THE ELCA DEVICE EVALUATION ON 10JAN2025, VISUAL INSPECTION FOUND SHARP EDGES AT THE DISTAL TIP. THIS REPORT CAPTURES THE ELCA WITH SHARP EDGES AT THE DISTAL TIP, POTENTIAL FOR HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21269037 ↗

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