Dragonfly™ DuoRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00183739000708), received between Oct 29, 2018 and Jan 3, 2023 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Contamination /Decontamination Problem” (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

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 3, 2023No Display/Image; Difficult to Remove; No Display/Image; Difficult to Remove

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED IN THE 85% STENOSED LESION IN THE LEFT ANTERIOR DESCENDING ARTERY. DURING PULLBACK, NO IMAGE WAS DISPLAYED AND SLIGHT RESISTANCE WAS FELT WITH THE ANATOMY DURING REMOVAL. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A NEW DRAGONFLY CATHETER. 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 16087695 ↗
• MalfunctionApr 20, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THE PROCEDURE WAS PERFORMED IN THE LEFT ANTERIOR DESCENDING ARTERY THAT WAS MILDLY TORTUOUS AND CALCIFIED. A DRAGONFLY DUO IMAGING CATHETER WAS INSERTED, BUT IN WAS OBSERVED ON X-RAY THAT A FOREIGN BODY WAS ON THE TIP OF THE DEVICE. THE CATHETER WAS PULLED BACK AND IT WAS OBSERVED THE FOREIGN BODY MOVED WITH THE CATHETER. THEREFORE, THE DEVICE WAS REMOVED. NO FOREIGN BODY WAS OBSERVED IN THE ANATOMY ON IMAGING AFTER THE CATHETER WAS REPLACED TO CONTINUE THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14164122 ↗
• MalfunctionAug 1, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  DURING THE PROCEDURE, THE CATHETER WAS UNABLE TO PASS THROUGH LESIONS. THE PROCEDURE WAS COMPLETED WITHOUT OCT WITH NO ADVERSE PATIENT CONSEQUENCES. ANALYSIS OF THE RETURNED DEVICE REVEALED THE DISTAL TIP WAS DETACHED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8850683 ↗
• InjuryOct 29, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PRE-DILATATION WITH A NON-ABBOTT BALLOON WAS PERFORMED IN LAD. NEXT, THE DRAGONFLY DUO IMAGING CATHETER REVEALED A THROMBUS IN LAD. ADDITIONAL STENTING WAS PERFORMED WITH TWO NON-ABBOTT STENTS AND FOLLOW UP BALLOONING FOR STENT MALPOSITION. THE DRAGONFLY DUO IMAGING CATHETER WAS THEN USED TO ASSESS LAD AND LEFT MAIN (LM). DURING THIS TIME, THE PATIENT'S BLOOD PRESSURE DROPPED AND THE OCT PROCEDURE WAS STOPPED. CPR WAS INITIATED, MEDICATIONS WERE ADMINISTERED AND THE PATIENT'S BLOOD PRESSURE WAS REVIVED BACK. THE PATIENT'S PRESSURE REMAINED UNCHANGED AFTER 40-45 MINUTES OF CPR AND INTRA-AORTIC BALLOON PUMP (IABP) INSERTION. THE PATIENT PASSED AWAY. THE PHYSICIAN DOES NOT BELIEVE THE OCT CAUSED THE ADVERSE EVENTS.

  Patient problems: Death; Low Blood Pressure/ Hypotension

  MAUDE report 8013648 ↗