ViewFlex™ H701374Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 05415067013743), received between Jun 10, 2019 and Apr 17, 2026 — classified as 3 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Communication or Transmission Problem” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 17, 2026Material Frayed; Sparking

  WHEN THE CABLE WAS PLUGGED IN, A VISIBLE SPARK WAS NOTED. THE CABLE WAS FRAYED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24906423 ↗
• MalfunctionJun 28, 2024Communication or Transmission Problem; Communication or Transmission Problem

  DURING A PULMONARY VEIN ISOLATION (PVI) PROCEDURE, COMMUNICATION ISSUES RESULTED IN A PROCEDURAL DELAY. IT WAS REPORTED THAT THE CIM FOR THE VIEWMATE MULTI DID NOT DISPLAY THE ICE PROBE. A DIFFERENT CIM WAS BORROWED FROM ANOTHER SITE TO COMPLETE THE PROCEDURE WHICH RESULTED IN A 2 HOUR DELAY. THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19638666 ↗
• MalfunctionMay 30, 2023Communication or Transmission Problem; Communication or Transmission Problem

  DURING THE START OF A PREMATURE VENTRICULAR TACHYCARDIA PROCEDURE, THE NEW CATHETER INTERFACE MODULE WAS UNABLE TO COMMUNICATE WITH THE VIEWMATE SYSTEM, WHICH RESULTED IN A DELAY. THE CATHETER AND CONSOLE WERE REPLACED WITH A NON-ABBOTT (BIOSENSE) SYSTEM AND THE PROCEDURE WAS COMPLETED WITHOUT ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17025250 ↗
• MalfunctionMar 31, 2023Communication or Transmission Problem; Communication or Transmission Problem

  THE DELAY IS NOT A REPORTABLE EVENT. AS THIS OCCURRED DURING A LEFT ATRIAL APPENDAGE CLOSURE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16658423 ↗
• MalfunctionJan 7, 2022Communication or Transmission Problem; Detachment of Device or Device Component; Communication or Transmission Problem; Detachment of Device or Device Component

  DURING AN ATRIAL FIBRILLATION ABLATION PROCEDURE, THE CATHETER INTERFACE MODULE (CIM) WOULD NOT RECOGNIZE THE ICE CATHETER AND THE PROCEDURE WAS CANCELLED AS A RESULT. THE CATHETER WAS INITIALLY REPLACED, BUT THE ISSUE REMAINED. A RATTLING SOUND WAS NOTED TO BE COMING FROM WITHIN THE CIM. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13192769 ↗
• MalfunctionApr 23, 2021Communication or Transmission Problem; Communication or Transmission Problem

  DURING A CRYO ATRIAL FIBRILLATION ABLATION PROCEDURE, THE CIM DID NOT RECOGNIZE THE CATHETERS. A TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) WAS PERFORMED INSTEAD WITH ANESTHESIA ADMINISTERED TO COMPLETE THE PROCEDURE SUCCESSFULLY WITH NO CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11715358 ↗
• InjuryMay 15, 2020Communication or Transmission Problem; Communication or Transmission Problem

  DURING A PROCEDURE, THE CATHETER INTERFACE MODULE (CIM) WOULD NO LONGER RECOGNIZE THE PROBES. THE PATIENT WAS ALREADY PREPARED WHEN THE PROCEDURE WAS CANCELLED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10060771 ↗
• InjuryDec 30, 2019Display or Visual Feedback Problem; Mechanical Problem; Display or Visual Feedback Problem; Mechanical Problem

  DURING A CRYO ATRIAL FIBRILLATION PROCEDURE, A RATTLING NOISE WAS HEARD WITHIN THE CIM AND THE UNIT DISPLAYED DARK IMAGES SO THE PROCEDURE WAS CANCELLED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT DUE TO THE CANCELLATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9530630 ↗
• InjuryJun 10, 2019Erratic or Intermittent Display; Erratic or Intermittent Display

  DURING A PROCEDURE, THE IMAGE WAS POOR WHEN THE ICE CATHETER WAS IN USE. DIFFERENT CATHETERS WERE USED BUT THE ISSUE REMAINED. AS NO REPLACEMENT CATHETER INTERFACE MODULE (CIM) WAS AVAILABLE, THE PROCEDURE WAS CANCELLED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8683609 ↗