Reflexion Spiral™ 402804Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 05414734206204), received between Sep 13, 2018 and May 1, 2023 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Material Frayed” (6 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 1, 2023Fracture; Fracture

  DURING AN ATRIAL FIBRILLATION PROCEDURE, THERE WAS A FRACTURE FOUND IN THE CATHETER SHAFT. AT THE END OF THE PROCEDURE, THE DAMAGE WAS OBSERVED BY X-RAY. IN THE PROXIMAL PART OF THE SHAFT, ABOUT 2 CM PROXIMAL TO THE NUMBER 20 POLE. AT THAT TIME THE PROCEDURE WAS FINISHED WITH NO ISSUES. THE PHYSICIAN ATTEMPTED TO PULL THE CATHETER INSIDE THE SHEATH, BUT IT WAS NOT POSSIBLE. INSTEAD, THE SHEATH AND CATHETER WERE REMOVED TOGETHER. THE DAMAGE ON THE CATHETER COULD THEN BE SEEN. THE INSULATE OF THE PROXIMAL PART WAS BROKEN AND A LITTLE WIRE WAS EXPOSED. THE SIGNALS WERE STABLE THROUGHOUT THE PROCEDURE, AND THE ONLY ISSUE WAS IN THE ANTERIOR DEFLECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16841896 ↗
• MalfunctionSep 29, 2022Fracture; Fracture

  DURING AN ATRIAL FIBRILLATION ABLATION PROCEDURE, THE CATHETER BROKE DURING INSERTION THROUGH THE SHEATH; INTERNAL WIRES WERE EXPOSED. THE CATHETER WAS EXCHANGED AND THE PROCEDURE WAS COMPLETED WITH NO CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15508617 ↗
• MalfunctionSep 28, 2022Fracture; Fracture

  DURING THE ATRIAL FIBRILLATION PROCEDURE, THE CATHETER FRACTURED WHILE MAPPING IN THE LEFT ATRIUM. THE CATHETER WAS ABLE TO BE REMOVED WITHOUT COMPLICATION AND EXCHANGED. THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15498576 ↗
• MalfunctionJun 29, 2022Material Separation; Material Separation

  DURING AN ATRIAL FIBRILLATION ABLATION PROCEDURE, THE CATHETER SHAFT SEPARATED. THE DEVICE WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14859185 ↗
• MalfunctionJul 6, 2021Fracture; Material Frayed; Fracture; Material Frayed

  TOWARDS THE END OF THE PROCEDURE, AS THE DEVICE WAS REMOVED, THE TIP OF THE SHAFT WAS FRACTURED AND A SHARP WIRE WAS STICKING OUT OF THE CATHETER. THE INTERNAL WIRING OF THE CATHETER CUT THROUGH THE COVERING OF THE CATHETER, EXPOSING THE WIRE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12120351 ↗
• MalfunctionApr 21, 2020Material Frayed; Material Frayed

  THIS EVENT IS BEING REPORTED BASED ON THE ANALYSIS OF THE RETURNED DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9980930 ↗
• MalfunctionFeb 11, 2020Material Frayed; Material Frayed

  DURING A PROCEDURE THERE WAS AN INSULATION SEPARATION AT THE DISTAL END OF THE SHAFT, THOUGH THERE WERE NO EXPOSED INTERNAL COMPONENTS. THE DEVICE WAS REPLACED AND THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9696143 ↗
• MalfunctionFeb 6, 2020Material Frayed; Activation, Positioning or Separation Problem; Material Frayed; Activation, Positioning or Separation Problem

  DURING AN ATRIAL FIBRILLATION PROCEDURE, THE CATHETER WOULD NOT DEFLECT AS INTENDED WHILE MAPPING. THE CATHETER WAS REMOVED FROM THE PATIENT AND UPON VISUAL INSPECTION, THE INSULATION OF THE CATHETER SHAFT HAD SPLIT. THE CATHETER WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9676032 ↗
• MalfunctionDec 12, 2019Material Frayed; Material Frayed

  DURING AN ATRIAL FIBRILLATION ABLATION, DURING THE PROCESS OF ISOLATING THE PULMONARY VEINS AND CHECKING TO ENSURE ELECTRICAL BLOCK WAS SUCCESSFUL, IT WAS NOTED THE CATHETER SEEMED TO HAVE LOST ITS SHAPE AND WAS HARD TO MANIPULATE WITHIN THE LEFT ATRIAL CHAMBER. THE CATHETER WAS UNABLE TO BE RETRIEVED BACK THROUGH THE SHEATH. A NEW CATHETER AND A DIFFERENT SHEATH WERE USED TO ADVANCE INTO THE LEFT ATRIUM AND COMPLETE THE PROCEDURE SUCCESSFULLY. UPON REMOVAL, THE CATHETER WAS STILL UNABLE TO PULL BACK INTO THE SHEATH TO REMOVE IT FROM THE BODY. ONCE THE CATHETER WAS ABLE TO BE REMOVED (STILL WITHIN THE SHEATH), IT WAS NOTED THAT PART OF THE CATHETER WAS BROKEN OFF, LEAVING WIRE UNDERNEATH AND THE OUTER INSULATION EXPOSED. THE OUTER PLASTIC PART OF THE CATHETER DIRECTLY BEFORE THE SPIRAL WAS ENTIRELY BROKEN OFF. THE PATIENT WAS STABLE WITH NO PATIENT CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9457885 ↗
• MalfunctionNov 11, 2019Material Frayed; Difficult to Insert; Material Frayed; Difficult to Insert

  DURING THE PROCEDURE, THE CATHETER WAS INSERTED INTO THE LEFT ATRIUM AND THE CHAMBER WAS MAPPED. THE CATHETER WAS MANEUVERED TO THE LEFT SUPERIOR PULMONARY VEIN BUT APPEARED STUCK AND UNABLE TO MOVE. THE CATHETER WAS MANIPULATED AND REMOVED FROM THE PATIENT AND VISUAL INSPECTION REVEALED AN EXPOSED CATHETER WIRING AND FRAYED OUTER MATERIAL. THE CATHETER WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9304378 ↗
• MalfunctionSep 26, 2019Difficult to Remove; Material Separation; Material Split, Cut or Torn; Difficult to Remove; Material Separation; Material Split, Cut or Torn

  DURING A PULMONARY VEIN ISOLATION PROCEDURE THE CATHETER BECAME STUCK IN THE PATIENT. WHILE MANEUVERING THE CATHETER IN THE RIGHT INFERIOR PULMONARY VEIN IN THE LEFT ATRIUM, A SNAP WITHIN THE CATHETER HANDLE WAS FELT. FLUOROSCOPY WAS USED TO TRY TO GUIDE THE CATHETER BACK INTO THE INTRODUCER BUT IT WAS NOT POSSIBLE SINCE THE CONTROL WIRE WAS EXPOSED. THE CATHETER AND INTRODUCER WERE REMOVED AS ONE UNIT TO THE INSERTION SITE. THE HANDLE OF THE CATHETER WAS CUT IN ORDER TO UTILIZE SHORT SHEATHS TO SAFELY RETRIEVE THE CATHETER. ONCE REMOVED, CONTRAST INJECTION WAS USED TO CHECK FOR ANY INJURY TO THE PATIENT DURING CATHETER/INTRODUCER WITHDRAWAL WITH NO TRAUMA OBSERVED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9124640 ↗
• MalfunctionJul 24, 2019Difficult to Remove; Material Separation; Material Split, Cut or Torn; Difficult to Remove; Material Separation; Material Split, Cut or Torn

  DURING A PULMONARY VEIN ISOLATION PROCEDURE, THE CATHETER BECAME STUCK IN THE PATIENT. AT THE START OF THE PROCEDURE THERE WAS NOISE NOTED ON THE DISTAL ELECTRODES OF THE REFLEXION SPIRAL CATHETER. THE PAIR WERE DESELECTED AND THE PROCEDURE WAS CONTINUED. AT THE END OF THE CASE THERE WAS RESISTANCE WHEN WITHDRAWING THE CATHETER BACK INTO THE INTRODUCER. THE CURVE OF THE CATHETER WAS READJUSTED BUT THERE WAS NO RESOLUTION. THE INTRODUCER AND CATHETER WERE WITHDRAWN AS ONE UNIT FROM THE RIGHT FEMORAL VEIN. THE CATHETER WAS VISUALLY INSPECTED AND A BREAK IN THE OUTSIDE CASE WAS NOTED ALONG WITH EXPOSURE OF THE PUSH-PULL CABLES AT THE PROXIMAL END OF THE SPIRAL/SHAFT CONNECTION. CONTRACT INJECTION WAS USED TO CHECK FOR ANY INJURY TO THE PATIENT DURING CATHETER/INTRODUCER WITHDRAWAL WITH NO TRAUMA OBSERVED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8823052 ↗
• MalfunctionSep 13, 2018Material Separation; Material Separation

  DURING A PROCEDURE, THE CATHETER DID NOT STEER ACCURATELY. THE CATHETER WAS REMOVED AND THE INSULATION OF THE CATHETER WAS SEPARATED WITH EXPOSED INTERNAL COMPONENTS. THE CATHETER WAS REPLACED AND THE PROCEDURE WAS CONTINUED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7873783 ↗