Woven M0047FMC006750Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 08714729902355), received between Jan 22, 2019 and Apr 13, 2023 — classified as 2 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (2 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 13, 2023Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THAT DURING A PROCEDURE TO TREAT AN ATRIAL FIBRILLATION (AFIB) ON THE LEFT ATRIUM, A WOVEN DIAGNOSTIC ELECTRODE CATHETER WAS SELECTED FOR USE. WHEN THE CATHETER WAS TAKEN OUT OF THE PATIENT AFTER THE PROCEDURE, IT WAS NOTICED THAT THE ELECTRODE PART WAS PEELED OFF. CATHETER WAS REPLACED AND THE ISSUE WAS RESOLVED. PROCEDURE WAS ABLE TO BE COMPLETED SUCCESSFULLY WITHOUT ANY PATIENT COMPLICATIONS. CATHETER WAS RETURNED TO THE SUPPLIER FOR LABORATORY ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16733233 ↗
• MalfunctionAug 18, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT A WOVEN DIAGNOSTIC ELECTRODE CATHETER WAS SELECTED FOR A ATRIAL FIBRILLATION ABLATION PROCEDURE. WHEN THE PACKAGING FOR THE CATHETER WAS OPENED IT WAS NOTED THAT DISTAL TIP WAS DISCOLORED AND CONTAMINATED. ANOTHER WOVEN CATHETER OF THE SAME LOT SELECTED FOR USED HOWEVER THIS CATHETER HAD THE SAME ISSUE. THE PROCEDURE WAS COMPLETED WITHOUT PATIENT COMPLICATIONS BEING REPORTED BY SWITCHING TO A DIFFERENT PRODUCT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10420755 ↗
• MalfunctionAug 18, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT A WOVEN DIAGNOSTIC ELECTRODE CATHETER WAS SELECTED FOR A ATRIAL FIBRILLATION ABLATION PROCEDURE. WHEN THE PACKAGING FOR THE CATHETER WAS OPENED IT WAS NOTED THAT DISTAL TIP WAS DISCOLORED AND CONTAMINATED. ANOTHER WOVEN CATHETER OF THE SAME LOT SELECTED FOR USED HOWEVER THIS CATHETER HAD THE SAME ISSUE. THE PROCEDURE WAS COMPLETED WITHOUT PATIENT COMPLICATIONS BEING REPORTED BY SWITCHING TO A DIFFERENT PRODUCT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10420728 ↗
• MalfunctionMay 26, 2020Contamination; Material Perforation; Contamination; Material Perforation

  IT WAS REPORTED THAT A WOVEN 7F DIAGNOSTIC ELECTRODE CATHETER WAS SELECTED FOR A VENTRICULAR TACHYCARDIA ABLATION PROCEDURE. HOWEVER IT WAS NOTED THAT THE CATHETER HAD A PEELING FEELING AND CONTAMINATES ON THE CATHETER. THE CATHETER WAS NOT USED AND THE PROCEDURE WAS COMPETED WITH ANOTHER WOVEN CATHETER WITH NO PATENT COMPLICATIONS BEING REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10087918 ↗
• MalfunctionOct 29, 2019Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE CATHETER TIP SHOWED SIGNS OF BURNING ON THE DISTAL ELECTRODE.PRIOR TO AN ABLATION PROCEDURE TO TREAT ATRIAL FIBRILLATION, WHILE UNPACKING THE DEVICE, IT WAS NOTICED THAT THE DISTAL TIP ELECTRODE SHOWED "SIGNS OF BURNING" AND WAS GREYER IN APPEARED COMPARED TO THE OTHER ELECTRODES. NO PATIENT COMPLICATIONS OCCURRED AS THE ISSUE OCCURRED OUTSIDE OF THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9253955 ↗
• InjuryJan 22, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PERICARDIAL EFFUSION WAS EXPERIENCED. ON (B)(6) 2019, DURING AN ABLATION PROCEDURE FOR ATRIAL FLUTTER AND ATRIAL FIBRILLATION, THE PHYSICIAN MAPPED IN THE RIGHT ATRIUM WITH AN INTELLAMAP ORION CATHETER AND ALSO ABLATED IN SEVERAL AREAS IN THE RIGHT ATRIUM WITH AN INTELLANAV MIFI OPEN-IRRIGATED CATHETER. IT WAS A DIFFICULT TRANSSEPTAL WITH NON-BOSTON SCIENTIFIC DEVICES. DURING TRANSSEPTAL, THE PHYSICIAN NOTICED A DROP IN THE PATIENT'S BLOOD PRESSURE, SO THE PHYSICIAN DID AN ECHOCARDIOGRAM AND OBSERVED AN EFFUSION. SO, HE PUT IN A PERICARDIOCENTESIS CATHETER POST TRANSSEPTAL BEFORE MAPPING ON THE LEFT SIDE, DRAINED FLUID OUT OF THE PERICARDIAL SPACE AND THEN MAPPED AND ABLATED IN THE LEFT ATRIUM. THE EFFUSION CONTINUED DURING MAPPING ABLATION IN THE LEFT ATRIUM. THEY ENDED UP OPENING THE PATIENT'S CHEST AND CLOSING THE AREA THAT CAUSED THE EFFUSION. THE PATIENT WAS DOING WELL AS OF (B)(6) 2019. THE PHYSICIAN WASN'T SURE IF THE EFFUSION HAPPENED IN TRANSSEPTAL. IT WAS REPORTED THAT THE PATIENT HAD A PERSISTENT LEFT SUBCLAVIAN VEIN, AN ABNORMAL STRUCTURAL ASPECT OF THE PATIENT. DURING THE TRANSSEPTAL ACCESS, IT WAS JUST THE TRANSSEPTAL EQUIPMENT AND THE WOVEN DIA

  Patient problems: Low Blood Pressure/ Hypotension; Pericardial Effusion

  MAUDE report 8266648 ↗
• InjuryJan 22, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PERICARDIAL EFFUSION WAS EXPERIENCED. ON (B)(6) 2019, DURING AN ABLATION PROCEDURE FOR ATRIAL FLUTTER AND ATRIAL FIBRILLATION, THE PHYSICIAN MAPPED IN THE RIGHT ATRIUM WITH AN INTELLAMAP ORION CATHETER AND ALSO ABLATED IN SEVERAL AREAS IN THE RIGHT ATRIUM WITH AN INTELLANAV MIFI OPEN-IRRIGATED CATHETER. IT WAS A DIFFICULT TRANSSEPTAL WITH NON-BOSTON SCIENTIFIC DEVICES. DURING TRANSSEPTAL, THE PHYSICIAN NOTICED A DROP IN THE PATIENT'S BLOOD PRESSURE, SO THE PHYSICIAN DID AN ECHOCARDIOGRAM AND OBSERVED AN EFFUSION. SO, HE PUT IN A PERICARDIOCENTESIS CATHETER POST TRANSSEPTAL BEFORE MAPPING ON THE LEFT SIDE, DRAINED FLUID OUT OF THE PERICARDIAL SPACE AND THEN MAPPED AND ABLATED IN THE LEFT ATRIUM. THE EFFUSION CONTINUED DURING MAPPING ABLATION IN THE LEFT ATRIUM. THEY ENDED UP OPENING THE PATIENT'S CHEST AND CLOSING THE AREA THAT CAUSED THE EFFUSION. THE PATIENT WAS DOING WELL AS OF (B)(6) 2019. THE PHYSICIAN WASN'T SURE IF THE EFFUSION HAPPENED IN TRANSSEPTAL. IT WAS REPORTED THAT THE PATIENT HAD A PERSISTENT LEFT SUBCLAVIAN VEIN, AN ABNORMAL STRUCTURAL ASPECT OF THE PATIENT. DURING THE TRANSSEPTAL ACCESS, IT WAS JUST THE TRANSSEPTAL EQUIPMENT AND THE WOVEN DIA

  Patient problems: Low Blood Pressure/ Hypotension; Pericardial Effusion

  MAUDE report 8266629 ↗