WEBSTER D6DR252CTRecalls & reported problems
Biosense Webster Inc · Class 2
All models of WEBSTER (29)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10846835004458), received between Feb 26, 2025 and Feb 26, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Twisted/Bent” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Material Twisted/Bent1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 26, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT A PATIENT UNDERWENT A SUPRAVENTRICULAR TACHYCARDIA (SVT) ABLATION PROCEDURE WITH A WEBSTER¿ ELECTROPHYSIOLOGY CATHETER WITH AUTO ID AND OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY AND THE DEVICES GOT ENTANGLED DURING THE PROCEDURE. THE PHYSICIAN WAS ATTEMPTING TO REMOVE THE OPTRELL CATHETER FROM THE VIZIGO SHEATH WHEN THE WEBSTER QUAD--THAT WAS IN THE HEART--GOT ENSNARED IN THE OPTRELL CATHETER GRID. MEANWHILE, THE OPTRELL CATHETER WAS STUCK IN THE SHEATH AND PULLED THE WEBSTER QUAD INTO THE SHEATH WITH IT. THIS EVENT DID NOT CAUSE AN INJURY TO THE PATIENT BUT WAS MORE OF A "HOLD UP" OR DELAY IN THE PROCEDURE. THE PHYSICIAN WASN'T QUITE SURE WHAT TO DO SO THEY ENDED UP CUTTING THE WEBSTER QUAD CATHETER AT THE HANDLE AND PULLED IT OUT OF THE BODY. DUE TO THE MULTIPLE MORPHOLOGIES, THE PROCEDURE WAS ABORTED AFTER THE CATHETERS WERE REMOVED FROM THE BODY. NO MEDICAL INTERVENTION WAS PERFORMED. THE PATIENT WAS UNDER AESTHESIA FOR AN UNKNOWN AMOUNT OF TIME. NO TRANSSEPTAL PUNCTURE WAS PERFORMED PRIOR TO CASE CANCELLATION. THE PATIENT'S LAST KNOWN STATUS WAS STABLE. THIS REPORT IS FOR THE WEBSTER¿ ELECTROPHYSIOLOGY CATHETER WITH AUTO ID. A SEPARATE REPORT WILL B
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21472522 ↗
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- Inquiry™ IBI-81104Irvine Biomedical, Inc. · CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING1 recall2 deaths64 reports
- DECANAV R7F282CTBiosense Webster Inc · CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING4 deaths108 reports
- LASSO NAV D134301Biosense Webster Inc · CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING2 deaths82 reports
- DECANAV R7D282CTBiosense Webster Inc · CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING1 death75 reports
- ACHIEVE ADVANCE™ 2ACH20Medtronic, Inc. · CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING3 deaths69 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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