ELCA Coronary Laser Atherectomy Catheter 114-009Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00813132025441), received between Jun 3, 2019 and May 14, 2025 — classified as 5 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (4 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, 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

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• InjuryJun 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CORONARY ATHERECTOMY PROCEDURE COMMENCED TO TREAT A SEVERELY CALCIFIED LESION IN THE MID RIGHT CORONARY ARTERY (RCA). A SPECTRANETICS ELCA CORONARY LASER ATHERECTOMY CATHETER WAS USED TO TREAT THE PATIENT. DURING LASING, A PERFORATION WAS NOTED IN THE RCA. RESCUE EFFORTS BEGAN IMMEDIATELY, WITH MEDICATIONS BEING USED TO STABILIZE THE PATIENT'S BLOOD PRESSURE. THEN, TWO PAPYRUS STENTS WERE PLACED TO SEAL THE PERFORATION, AND THE PROCEDURE WAS COMPLETED. THE PATIENT SURVIVED, AND 48 HOURS POST-PROCEDURE, WAS DOING WELL. 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 19619928 ↗
• InjuryMar 10, 2023Material Separation; Detachment of Device or Device Component; Material Separation; Detachment of Device or Device Component

  A CORONARY ATHERECTOMY PROCEDURE COMMENCED TO TREAT A SLIGHTLY CALCIFIED SOFT TISSUE LESION IN THE PATIENT'S MID RIGHT CORONARY ARTERY (RCA). A STENT WAS PRESENT IN THE AREA, WITH SLIGHT IN-STENT RESTENOSIS (ISR) NOTED. THE PHYSICIAN CHOSE A SPECTRANETICS ELCA CORONARY ATHERECTOMY CATHETER TO TREAT THE PATIENT. DURING THE PROCEDURE, THE DISTAL MARKER BAND SEPARATED FROM THE DEVICE INSIDE THE PATIENT. AN ADDITIONAL GUIDE WIRE, ALONG WITH A TELEFLEX GUIDELINER CATHETER WERE ADVANCED, AND A BALLOON WAS USED TO SUCCESSFULLY RETRIEVE THE MARKER BAND FROM THE PATIENT. THE PATIENT SURVIVED THE PROCEDURE. THIS EVENT CAPTURES THE ELCA IN USE WHEN THE MARKER BAND SEPARATED, REQUIRING INTERVENTION FOR REMOVAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16524684 ↗
• MalfunctionJul 7, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  A CORONARY ATHERECTOMY PROCEDURE COMMENCED TO TREAT A MODERATELY CALCIFIED LESION IN THE PATIENT''S RIGHT CORONARY ARTERY (RCA). THE PHYSICIAN CHOSE A SPECTRANETICS ELCA CORONARY ATHERECTOMY CATHETER TO TREAT THE PATIENT. AFTER LASING WAS COMPLETED, THE ELCA''S DISTAL MARKER BAND DETACHED WHILE INSIDE THE PATIENT BUT REMAINED PRESENT ON THE GUIDE WIRE. NO ADDITIONAL INTERVENTION WAS REQUIRED FOR RETRIEVAL. THE CASE WAS COMPLETED SUCCESSFULLY WITH NO REPORTED PATIENT HARM. THIS REPORT CAPTURES THE ELCA DEVICE IN USE WHEN ITS MARKER BAND DETACHED, POTENTIAL FOR HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14949310 ↗
• InjuryFeb 5, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  A CORONARY VASCULAR INTERVENTION PROCEDURE COMMENCED. THE PROCEDURE INDICATION WAS REPORTED TO TREAT UNDEREXPANDED STENTS PRESENT IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE PHYSICIAN USED A SPECTRANETICS ELCA DEVICE AND SUCCESSFULLY COMPLETED TEN PASSES WITH THE DEVICE IN THIS AREA. WHEN THE PHYSICIAN PULLED THE ELCA CATHETER OUT THROUGH THE STENTS, THE RADIOPAQUE MARKER BAND (NORMALLY PRESENT AT THE DEVICE'S' DISTAL TIP) DETACHED IN THE PATIENT'S ARTERY. A SAPPHIRE BALLOON WAS USED TO RETRIEVE THE MARKER BAND SUCCESSFULLY. THE PATIENT SURVIVED THE PROCEDURE WITH NO REPORTED PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9672537 ↗
• MalfunctionNov 6, 2019Crack; Fracture; Material Split, Cut or Torn; Crack; Fracture; Material Split, Cut or Torn

  A CORONARY VASCULAR INTERVENTION PROCEDURE COMMENCED TO TREAT AN IN STENT RESTENOSIS (ISR) WITHIN THE PATIENT'S CIRCUMFLEX ARTERY. THE TEAM REPORTED THAT WHEN THEY ATTEMPTED TO LOAD THE ELCA LASER SHEATH ONTO THE WIRE, THEY NOTICED THAT THERE WAS DAMAGE NEAR THE TIP OF THE ELCA LASER CATHETER. THE ELCA DEVICE WAS REMOVED, AND ANOTHER ELCA DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE CASE. THIS EVENT IS BEING REPORTED DUE TO THE POTENTIAL FOR EXPOSURE TO MANUFACTURING MATERIALS AS WELL AS INADVERTENT EXPOSURE TO LASER ENERGY/RADIATION.

  Patient problems: Iatrogenic Source; Radiation Exposure, Unintended

  MAUDE report 9287495 ↗
• InjuryJun 3, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  DURING A CORONARY VASCULAR INTERVENTION PROCEDURE TO TREAT A SLIGHTLY CALCIFIED PLAQUE LESION WITHIN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY, A SPECTRANETICS ELCA DEVICE WAS IN USE. DURING USE, THE DEVICE''S MARKER BAND REPORTEDLY DETACHED FROM THE DEVICE. PHYSICIAN WAS LASING IN CONTRAST MEDIUM WHEN THE EVENT OCCURRED. THE DEVICE'S MARKER BAND WAS RETRIEVED WITH BALLOON. A BALLOON WAS USED TO COMPLETE THE PROCEDURE WITH NO REPORTED PATIENT HARM.

  Patient problems: Iatrogenic Source; No Consequences Or Impact To Patient

  MAUDE report 8662864 ↗