Halo 116008RTRecalls & reported problems
Biosense Webster Inc · Class 2
- 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 10846835001761), received between Aug 3, 2024 and Aug 3, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Entrapment of Device” (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.
Reports received per month
Most reported problems
Device problems
- Entrapment of Device1
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.
MalfunctionAug 3, 2024Entrapment of Device; Entrapment of Device
IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A HALO AND WEBSTER CS AND THE DEVICES WERE ENTANGLED WITH EACH OTHER WITHIN THE PATIENT¿S BODY. DURING REDO PVI AND RIGHT SIDES FLUTTER ABLATION THE HALO CATHETER GOT TRAPPED AND ENTANGLED AROUND THE WEBSTER CS CATHETER. THE PHYSICIAN WAS UNABLE TO PULL OUT THE CATHETERS NOR WAS HE ABLE TO DETANGLE THEM. A JUGULAR APPROACH WITH A FISHING DEVICE WAS NEEDED TO EVACUATE BOTH CATHETERS FROM THE BODY. THE PATIENT LEFT OPERATING ROOM UNHARMED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19901544 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.