WEBSTER D6DR252RTRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10846835000252), received between Nov 27, 2019 and Feb 15, 2022 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “No Display/Image” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 15, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A MALE PATIENT, BORN ON (B)(6), UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A WEBSTER¿ ELECTROPHYSIOLOGY CATHETER AND A CARTO® 3 SYSTEM AND SUFFERED A CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS AND A MAP SHIFT (NO ERROR MESSAGE/NO PATIENT MOVEMENT/CARDIOVERSION) ISSUE OCCURRED. IT WAS REPORTED THAT THERE WAS A PATIENT INJURY, A PERFORATION. THE CALLER REPORTED THAT EARLIER IN THE CRYOABLATION CASE, A TRANSEPTAL SHEATH SLIPPED OUT OF THE LEFT ATRIUM AND A CATHETER WAS INSERTED THROUGH IT TO PROBE FOR THE TRANSEPTAL HOLE, AND THE CATHETER WAS SEATED BACK INTO THE LEFT ATRIUM. LATER IN THE CASE, THE PATIENT'S BLOOD PRESSURE DROPPED, AND USING INTRACARDIAC ECHOCARDIOGRAPHY (ICE), A PERICARDIAL EFFUSION WAS CONFIRMED. THE PHYSICIAN'S OPINION WAS THAT THIS HAPPENED WHEN THEY WERE ATTEMPTING TO GET THE CATHETER BACK INTO THE LEFT ATRIUM. A PERICARDIOCENTESIS WAS PERFORMED AND 400CC OF BLOOD WAS REMOVED AND THE DRAIN WAS LEFT IN. THE PATIENT WAS ADMITTED OVERNIGHT FOR OBSERVATION. A DAY AFTER THE PROCEDURE, THE PATIENT WAS IN STABLE CONDITION. DURING THE PROCEDURE, TWO TRANSEPTAL PUNCTURES WERE PERFORMED WITH AN ABBOTT BRK XS NEEDLE. A CAVOTRICU

  Patient problems: Cardiac Perforation

  MAUDE report 13538937 ↗
• MalfunctionNov 27, 2019No Display/Image; No Display/Image

  IT WAS REPORTED THAT A UNDERWENT AN ABLATION PROCEDURE WITH A WEBSTER QUADRAPOLAR WITH AUTO ID ¿ DEFLECTABLE CATHETER, AND COMPLETE LOSS ON ALL ECG SIGNALS OCCURRED. AFTER THE CATHETER WAS INSERTED INTO THE PATIENT¿S BODY, THERE WAS NO ECG SIGNAL ON NEITHER THE CARTO NOR THE RECORDING SYSTEMS. THE CUSTOMER INDICATED THAT NO ADDITIONAL MONITORS WERE AVAILABLE FOR THE PHYSICIAN. THE PATIENT WAS UNDER GENERAL ANESTHESIA. THERE WERE NO PATIENT CONSEQUENCE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. THE OBSERVED COMPLETE LOSS ON ALL ECG SIGNALS HAS BEEN ASSESSED AS AN MDR REPORTABLE MALFUNCTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9382103 ↗