Dragonfly OPTISRecalls & reported problems across all models

We found 2 models of Dragonfly OPTIS by Lightlab Imaging, Inc. in the FDA's device registry (GUDID). Together they are named in 181 adverse event reports in the FDA's MAUDE database, received between Jun 21, 2018 and Jan 19, 2026 — classified as 4 deaths, 61 injuries, 116 malfunctions.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (34 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 Dragonfly OPTIS problems

Dragonfly OPTIS models

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

• Dragonfly™ OPTIS™ C408646

  CATHETER, INTRAVASCULAR, DIAGNOSTIC
  4 deaths150 reports
• Dragonfly™ OPTIS™ C408645

  CATHETER, INTRAVASCULAR, DIAGNOSTIC
  31 reports

Recent Dragonfly OPTIS adverse event reports

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

• MalfunctionJan 19, 2026Communication or Transmission Problem; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY WITH 80% STENOSIS. THE DRAGONFLY OPTIS IMAGING CATHETER DID NOT WORK NORMALLY AND DISPLAYED ERROR CODE 395. ANOTHER DRAGONFLY OPTIS WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. RETURNED DEVICE ANALYSIS IDENTIFIED A LONGITUDINAL TEAR OBSERVED IN THE WINDOW TUBE REGION OVER A LENGTH OF 2.5 MILLIMETERS DISTALLY FROM THE EXIT NOTCH. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24109181 ↗
• MalfunctionJan 5, 2026Poor Quality Image; Material Split, Cut or Torn

  IT WAS REPORTED THE DRAGONFLY OPTIS IMAGING CATHETER WAS TO BE USED IN THE LEFT CIRCUMFLEX (LCX) LESION. HOWEVER, THE CORRECT IMAGE FAILED TO DISPLAY. THEREFORE, THE IMAGING CATHETER WAS REMOVED AND ANOTHER DRAGONFLY OPTIS IMAGING CATHETER WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. RETURNED DEVICE ANALYSIS FOUND THE BLACK SHEATH WAS TORN FOR APPROXIMATELY 1.3 CENTIMETERS, 22 CENTIMETERS FROM THE PROXIMAL END OF THE INNER SHELL. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23957637 ↗
• MalfunctionJan 2, 2026Calibration Problem; Material Split, Cut or Torn

  IT WAS REPORTED, THAT DURING THE PROCEDURE THE DRAGONFLY OPTIS IMAGING CATHETER WAS INTENDED TO BE USED IN THE LEFT CIRCUMFLEX ARTERY (LCX) LESION. HOWEVER, THE IMAGING CATHETER DISPLAYED ERROR CODE 122. THEREFORE, THE IMAGING CATHETER WAS REMOVED FROM THE PATIENT, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER DRAGONFLY. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. BASED ON THE RESULTS OF THE DEVICE ANALYSIS, THE GUIDEWIRE EXCHANGE MINIRAIL WAS TORN APPROXIMATELY 4 MILLIMETERS (MM) DISTALLY FROM THE EXIT NOTCH. TORN MATERIAL HAS THE POTENTIAL TO RESULT IN FOREIGN MATERIAL IN THE PATIENT AND IS REPORTABLE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23950422 ↗
• MalfunctionNov 26, 2025Improper or Incorrect Procedure or Method; Air/Gas in Device; Improper or Incorrect Procedure or Method; Air/Gas in Device

  SUBSEQUENT TO THE INITIALLY FILED REPORT, FOLLOW UP WAS RECEIVED THAT THE DEVICE WAS LOADED ONTO THE GUIDE WIRE THAT ENTERED THE PATIENT VESSEL. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23662067 ↗
• MalfunctionJul 25, 2025Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT THE DRAGONFLY OPTIS IMAGING CATHETER, TYVEK POUCH WAS NOTED TO BE DAMAGED. THE UPPER LEFT CORNER OF THE POUCH WAS DAMAGED, CAUSING THE STERILITY BREACH. THEREFORE, THE DEVICE WAS NOT USED IN THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER DRAGONFLY. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22613637 ↗
• MalfunctionJul 10, 2025Failure to Advance; Material Split, Cut or Torn; Failure to Advance; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED IN THE RIGHT CORONARY ARTERY (RCA) WITH 80% STENOSIS. THE DRAGONFLY OPTIS IMAGING CATHETER WAS USED PRIOR TO THE STENT BEING IMPLANTED; HOWEVER, FAILED TO CROSS DUE TO THE ANATOMY POST STENT IMPLANTATION. ANOTHER DRAGONFLY OPTIS CATHETER WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. RETURNED DEVICE ANALYSIS IDENTIFIED THE GUIDEWIRE EXIT NOTCH WAS STRETCHED AND TORN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22473758 ↗
• MalfunctionJul 8, 2025Contamination /Decontamination Problem; Communication or Transmission Problem; Material Split, Cut or Torn; Contamination /Decontamination Problem; Communication or Transmission Problem; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE DRAGONFLY OPTIS IMAGING CATHETER WAS UNABLE TO CONNECT TO THE SYSTEM DURING PREPARATION AND THE DEVICE WAS FOUND TO BE CONTAMINATED. AN ERROR MESSAGE "CONNECTION FAILURE" WAS DISPLAYED. ANOTHER DRAGONFLY OPTIS IMAGING CATHETER WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED. RETURN DEVICE ANALYSIS NOTED THE GUIDE WIRE EXIT NOTCH WAS TORN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22438740 ↗
• MalfunctionJun 30, 2025No Display/Image; Difficult to Remove; Material Separation; No Display/Image; Difficult to Remove; Material Separation

  IT WAS REPORTED THE DRAGONFLY OPTIS IMAGING CATHETER WAS TO BE USED IN THE RIGHT CORONARY ARTERY (RCA). HOWEVER, THE IMAGING CATHETER FAILED TO IMAGE. THEREFORE, THE IMAGING CATHETER WAS REMOVED AND ANOTHER DRAGONFLY OPTIS IMAGING CATHETER WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. RETURNED DEVICE ANALYSIS IDENTIFIED THE BLACK SHEATH WAS SEPARATED FROM THE WINDOW TUBE THAT INCLUDES THE DISTAL MARKER BAND AND CATHETER DISTAL TIP. THE ACCOUNT CONFIRMED THE SEPARATION OCCURRED DURING REMOVAL FROM THE Y VALVE WHEN THE CONTRAST AGENT IN THE CATHETER GOT STUCK TO THE VALVE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22366275 ↗
• MalfunctionJun 5, 2025Break; Poor Quality Image; Break; Poor Quality Image

  IT WAS REPORTED THE DRAGONFLY OPSTAR IMAGING CATHETER WAS TO BE USED IN THE PROXIMAL TO MID LEFT CIRCUMFLEX LESION. HOWEVER, THE IMAGE WAS FAULTY. IT WAS ALSO NOTED THE IMAGING CATHETER MAY HAVE FRACTURED BY HITTING THE STENT STRUTS. THEREFORE, THE IMAGING CATHETER WAS REMOVED AND A NON-ABBOTT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22152661 ↗
• MalfunctionJun 2, 2025Difficult or Delayed Positioning; Fluid/Blood Leak; Difficult to Advance; Material Split, Cut or Torn; Difficult or Delayed Positioning; Fluid/Blood Leak; Difficult to Advance; Material Split, Cut or Torn

  IT WAS REPORTED; THE DRAGONFLY OPTIS IMAGING CATHETER WAS TO BE USED IN THE LEFT ANTERIOR DESCENDING (LAD) LESION WITH RESISTANCE. HOWEVER, THE LENS MARKERS WAS NOT TRACKING ON THE WIRE. ONCE REMOVED, IT WAS NOTED A LEAK FROM A HOLE HALFWAY BETWEEN THE DISTAL AND LENS MARKERS. THEREFORE, THE PROCEDURE COMPLETED WITHOUT USING A REPLACEMENT. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22127241 ↗
• MalfunctionMay 14, 2025No Display/Image; Poor Quality Image; Material Split, Cut or Torn; No Display/Image; Poor Quality Image; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE INTERVENTRICULAR CORONARY ARTERY WITH NO TORTUOSITY OR CALCIFICATION. DURING USE OF THE DRAGONFLY OPTIS IMAGING CATHETER, AFTER ENTERING THE ANATOMY WHEN TRYING TO CONNECT TO THE ILUMIN OPTIS SYSTEM, AN ARTIFACT IMAGE OCCURRED AND IT WAS NOT POSSIBLE TO DISPLAY AN IMAGE WITHOUT AN ERROR MESSAGE THAT SAID 'PROBE NOT CONNECTED'. AN ATTEMPT WAS MADE TO RESET BY DISCONNECTING AND RECONNECTING THE CATHETER AND ANOTHER ERROR MESSAGE WAS DISPLAYED. A NEW CATHETER WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. RETURNED DEVICE ANALYSIS IDENTIFIED THAT THERE WAS A TEAR ON THE WINDOW TUBE AND THE WINDOW TUBE WAS SEPARATED FROM THE BLACK SHEATH BUT HELD TOGETHER BY THE TORQUE WIRE. THE ACCOUNT WAS NOT AWARE OF THE DAMAGE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22023059 ↗
• MalfunctionMay 6, 2025Communication or Transmission Problem; Material Split, Cut or Torn; Communication or Transmission Problem; Material Split, Cut or Torn

  IT WAS REPORTED THE DRAGONFLY OPTIS IMAGING CATHETER WAS TO BE USED IN THE LEFT ANTERIOR DESCENDING (LAD) LESION. HOWEVER, THE IMAGING CATHETER FAILED TO BE RECOGNIZED BY THE SYSTEM. AN ERROR "CONNECTION FAILURE(395)" MESSAGE WAS DISPLAYED. THEREFORE, THE IMAGING CATHETER WAS REMOVED AND ANOTHER DRAGONFLY OPTIS IMAGING CATHETER WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED. RETURNED DEVICE ANALYSIS FOUND THE GUIDE WIRE EXIT NOTCH WAS TORN FOR A LENGTH OF 1MM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21973703 ↗
• MalfunctionApr 30, 2025Poor Quality Image; Material Split, Cut or Torn; Poor Quality Image; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE DRAGONFLY OPTIS IMAGING CATHETER WAS INTENDED TO BE USED IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD) LESION. HOWEVER, THE IMAGING CATHETER DISPLAYED ABNORMAL IMAGES. THEREFORE, THE IMAGING CATHETER WAS REMOVED FROM THE PATIENT, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER DRAGONFLY. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. RETURNED DEVICE ANALYSIS IDENTIFIED GUIDE WIRE EXIT NOTCH WAS STRETCHED AND TORN DISTALLY FOR 3.5 MM. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21938081 ↗
• MalfunctionMar 11, 2025Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED THAT DURING PREPARATION WITHOUT PATIENT INVOLVEMENT, THE DRAGONFLY OPTIS IMAGING CATHETER WAS REMOVED FROM THE CHIPBOARD BOX WHEN IT WAS NOTED THAT THE PLASTIC BAG PACKAGING WAS NOT SEALED, AND THE STERILITY IS BREACHED. A NEW DRAGONFLY OPTIS WAS USED SUCCESSFULLY FOR THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAYS IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21575369 ↗
• MalfunctionMar 4, 2025No Display/Image; Material Split, Cut or Torn; No Display/Image; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE DRAGONFLY OPTIS IMAGING CATHETER DID NOT PROVIDE AN IMAGE PRIOR TO USE. THEREFORE, THE DEVICE WAS NOT USED IN THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER DRAGONFLY. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. RETURN ANALYSIS REVEALED THE BLACK SHEATH WAS PUNCTURED AT 19 CENTIMETERS (CM) AND TORN AT 103 AND 112 CM FROM THE PROXIMAL END OF THE OUTER SHELL. NO ADDITIONAL INFORMATION WAS PROVIDED. HOLD I.P 03052025

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21518630 ↗

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