ViewFlex™ D087031Recalls & reported problems

Summary

The FDA's MAUDE database contains 341 adverse event reports that list this exact device (DI 05415067002082), received between Jun 15, 2018 and Sep 25, 2026 — classified as 3 deaths, 31 injuries, 307 malfunctions.

The most frequently reported specific device problem is “Fracture” (283 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 25 most recent of 341 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2026Fracture

  During an atrial fibrillation procedure, a crack was observed on the tip of the ViewFlex Xtra ICE catheter while the device was being maneuvered through tortuous anatomy. The user reported difficulty obtaining inferior vena cava (IVC) vascular access and noted that significant force was required during device insertion. It was also noted that multiple procedural devices became bent during the procedure. The catheter was exchanged, and the procedure was completed with no adverse patient consequences.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50898833 ↗
• MalfunctionAug 7, 2026Fracture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50177697 ↗
• MalfunctionApr 3, 2026Fracture

  THIS REPORT IS TO ADVISE OF A FRACTURE FOUND IN THE CATHETER TIP DURING INVESTIGATION. DURING THE AF PROCEDURE, IT WAS NOTED THAT THERE WAS NOISE ON THE IMAGE. THE CATHETER WAS EXCHANGED, AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24777607 ↗
• MalfunctionMar 25, 2026Fracture

  THIS REPORT IS TO ADVISE OF A FRACTURE FOUND IN THE CATHETER TIP DURING ANALYSIS. DURING THE AF PROCEDURE, THERE WAS AN ISSUE WITH THE TIP CURVE. BEFORE CONTACTING THE PATIENT FOR THE FIRST TIME, THE CURVE WAS NOT CONTROLLED AS EXPECTED. IT WAS INSERTED INTO THE PATIENT AND CONTROLLED, BUT IT ALSO DID NOT BEND AS EXPECTED. THE CATHETER WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24689077 ↗
• MalfunctionMar 23, 2026Fracture

  THIS REPORT IS TO ADVISE OF A FRACTURE THAT WAS NOTED DURING ANALYSIS. DURING THE PROCEDURE, WHEN INSERTING THE VIEWFLEX ICE CATHETER INTO THE HEART, IT WAS NOTED THAT THE CATHETER WENT OUT A BRANCH OF THE IVC AND SIGNIFICANTLY BENT AT THE TIP. AFTER THAT, THE CATHETER WAS NOTED TO NOT STEER CORRECTLY. IT WAS DETERMINED THAT THE STEERING MECHANISM WAS NO LONGER FUNCTIONING. THE CATHETER WAS REPLACED, WHICH RESOLVED THE ISSUE, AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24664323 ↗
• MalfunctionMar 5, 2026Fracture

  DURING AN ATRIAL FIBRILLATION PROCEDURE, THE CATHETER WAS INSERTED INTO THE PATIENT, BUT THE CATHETER IMAGING WAS UNCLEAR. UPON INSPECTION, IT WAS FOUND THAT THE TIP WAS DAMAGED. THE CATHETER WAS REPLACED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24527367 ↗
• MalfunctionMar 2, 2026Fracture

  DURING A PFA PROCEDURE USING A NON-ABBOTT SHEATH (FARADRIVE BY BOSTON SCIENTIFIC), WHEN PREPARING TO DO THE TRANSEPTAL PUNCTURE, THE VIEWFLEX CATHETER WAS INSERTED THROUGH THE FEMORAL ACCESS. RESISTANCE WAS NOTED WHEN REACHING THE EXTERNAL ILIAC. THE CATHETER WAS REMOVED FROM THE PATIENT, AND A FRACTURED TIP WAS OBSERVED. THE CATHETER WAS REPLACED, AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24489308 ↗
• MalfunctionFeb 25, 2026Fracture

  THIS REPORT IS TO ADVISE OF A FRACTURE FOUND IN THE CATHETER TIP DURING ANALYSIS. DURING PROCEDURE, THE TIP WAS FOUND TO BE BENT WHEN REMOVING THE ICE CATHETER FROM THE PATIENT¿S BODY AFTER THE BROCKEN BROUGH. THE CATHETER WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ABNORMALITY OR TENSION WAS NOTED WHILE MANIPULATING THE CATHETER, SO THE CAUSE OF THE BENDING WAS UNKNOWN. THE CATHETER WAS CAREFULLY REMOVED FROM THE BOX, AND THE CATHETER WAS NOT INSERTED INTO THE SHEATH WHILE THE CATHETER WAS DEFLECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24439097 ↗
• MalfunctionFeb 23, 2026Fracture

  THIS REPORT IS TO ADVISE OF A FRACTURE FOUND IN THE CATHETER TIP DURING INVESTIGATION. DURING THE AF PROCEDURE, IT WAS NOTED THAT THE ICE CATHETER IMAGE QUALITY WAS POOR. ONCE THE CATHETER WAS REMOVED FROM THE PATIENT, IT WAS NOTED THAT THE CATHETER TIP WAS BENT. THE CATHETER WAS REPLACED, AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24417547 ↗
• MalfunctionJan 29, 2026Fracture

  DURING AN ATRIAL FIBRILLATION PROCEDURE WITH PULSED FIELD ABLATION, THE CATHETER TIP WAS FRACTURED. WHEN THE CATHETER WAS INSERTED THROUGH A 10F SHEATH, A SHARP 90-DEGREE BEND WAS SEEN ON FLUOROSCOPY. THE CATHETER WAS REMOVED AND THE FRACTURE WAS CONFIRMED. THE CATHETER WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24212765 ↗
• MalfunctionJan 15, 2026Fracture

  DURING THE AF PROCEDURE, AFTER THE CATHETER WAS INTRODUCED, IT WAS FOUND THAT THE CATHETER WAS POORLY CURVED. THE CATHETER WAS NOTED TO HAVE A CRACK AT THE END OF IT. THE CATHETER WAS REPLACED, AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24081220 ↗
• MalfunctionJan 14, 2026Fracture

  THIS REPORT IS TO ADVISE OF A FRACTURE FOUND IN THE CATHETER TIP DURING INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24072137 ↗
• MalfunctionJan 13, 2026Fracture

  THIS REPORT IS TO ADVISE OF A FRACTURE FOUND IN THE CATHETER TIP DURING INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24061038 ↗
• MalfunctionJan 13, 2026Fracture

  THIS REPORT IS TO ADVISE OF A FRACTURE FOUND IN THE CATHETER TIP DURING INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24060359 ↗
• MalfunctionJan 13, 2026Fracture

  THIS REPORT IS TO ADVISE OF A FRACTURE FOUND IN THE CATHETER TIP DURING INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24059846 ↗
• MalfunctionDec 30, 2025Fracture; Fracture

  DURING THE ATRIAL FIBRILLATION PROCEDURE, IT WAS NOTED THAT THE CATHETER TIP WAS FRACTURED WHEN REMOVED FROM THE PATIENT. THE CATHETER WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT. PRIOR TO CATHETER INSERTION INTO THE PATIENT, NO DEVICE DAMAGE WAS NOTED. THE PHYSICIAN NOTED THE IRREGULARITY IN THE TIP SHAPE UNDER FLUOROSCOPY AROUND THE TIME OF THE TRANSSEPTAL PUNCTURE. NO EXCESSIVE FORCE WAS APPLIED TO THE TIP. THERE WAS NO RESIDUAL MATERIAL LEFT IN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23919432 ↗
• MalfunctionDec 17, 2025Fracture; Fracture

  DURING THE ATRIAL FIBRILLATION PROCEDURE, IT WAS NOTED THAT THE TIP OF THE CATHETER WAS FRACTURED WHEN REMOVED FROM THE PATIENT. WHILE ADVANCING THE CATHETER, DISTORTION WAS NOTED ON THE IMAGE. THE CATHETER WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23831080 ↗
• MalfunctionDec 17, 2025Fracture; Fracture

  THIS REPORT IS TO ADVISE OF A FRACTURE FOUND IN THE CATHETER TIP DURING INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23826981 ↗
• MalfunctionDec 2, 2025Fracture; Fracture

  THIS REPORT IS TO ADVISE OF A FRACTURE FOUND IN THE TIP OF THE VIEWFLEX CATHETER DURING ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23698186 ↗
• MalfunctionDec 2, 2025Fracture; Improper or Incorrect Procedure or Method; Fracture; Improper or Incorrect Procedure or Method

  DURING THE AF PROCEDURE, WHEN THE VIEWFLEX CATHETER WAS INSERTED, THE IMAGE DISPLAYED NOISE, APPEARING AS A BLACK LINE. THE CATHETER WAS REPLACED, AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT. A 9F SHEATH WAS USED WHEN A 10F SHOULD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23689790 ↗
• InjuryNov 20, 2025Fracture; Material Separation; Fracture; Material Separation

  DURING THE PROCEDURE, THE CATHETER TIP DETACHED AND WAS LODGED IN THE SHEATH. THIS OCCURRED WHEN INSERTING THE CATHETER INTO THE 10F SHEATH. THE SHEATH WAS REMOVED AND EXCHANGED FOR A NEW SHEATH AND CATHETER WITH NO ISSUES. THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23610360 ↗
• MalfunctionNov 20, 2025Fracture; Difficult to Insert; Fracture; Difficult to Insert

  DURING THE ATRIAL FIBRILLATION PROCEDURE, THE CATHETER TIP FRACTURED WHEN INSERTED INTO THE PATIENT. THE CATHETER WAS INSERTED INTO THE SHEATH AND RESISTANCE WAS FELT, SO THE CATHETER WAS RETRACTED AND IT WAS NOTED THAT THE TIP OF THE CATHETER HAD FRACTURED. THE CATHETER WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23605205 ↗
• MalfunctionNov 17, 2025Fracture; Fracture

  DURING THE PFA PROCEDURE, THERE WAS RESISTANCE WHEN INSERTING THE DEVICE. IT WAS THEN NOTED ON FLUORO THAT THE TIP WAS FRACTURED. IT WAS NOTED THAT THE PATIENT RIGHT GROIN ANATOMY WAS CHALLENGING. THE DEVICE WAS REMOVED FROM THE PATIENT AND REPLACED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23572647 ↗
• InjuryNov 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A PVC PROCEDURE, A PERICARDIAL EFFUSION OCCURRED WHICH REQUIRED A PERICARDIOCENTESIS. RETROGRADE APPROACH WAS USED AND MAPPING AND ABLATION WAS PERFORMED IN THE LEFT VENTRICLE OUTFLOW TRACT (LVOT). THE ADVISOR HD GRID MAPPING CATHETER WAS POSITIONED IN THE RIGHT VENTRICULAR OUTFLOW TRACT (RVOT). THE POINTS WERE EARLIER THERE SO PRIOR TO MOVING THE ABLATION CATHETER FROM THE LVOT TO RVOT, THE PHYSICIAN PERFORMED AN ICE SWEEP WHICH REVEALED A PERICARDIAL EFFUSION. A PERICARDIOCENTESIS WAS DONE AND 200CC WERE DRAINED. THE PHYSICIAN THINKS THE VIEWFLEX IS THE LIKELY CAUSE OF THE EFFUSION BECAUSE OF VENOUS BLOOD AS OPPOSED TO ARTERIAL BLOOD. THE PATIENT HAS SINCE BEEN DISCHARGED. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICE.

  Patient problems: Cardiac Perforation

  MAUDE report 23550577 ↗
• MalfunctionNov 10, 2025Fracture; Fracture

  DURING THE ATRIAL FIBRILLATION PROCEDURE, APPROXIMATELY 30 MINUTES AFTER INSERTION OF THE CATHETER INTO THE BODY, FLUOROSCOPIC IMAGING REVEALED WHAT APPEARED TO BE A FRACTURE AT THE CATHETER TIP WITHIN THE RIGHT ATRIUM. ICE IMAGES WERE DISPLAYED WITHOUT ISSUE; HOWEVER, UPON REMOVAL OF THE CATHETER FROM THE PATIENT, THE TIP WAS FOUND TO BE BROKEN. THE CATHETER WAS REPLACED, AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23519315 ↗