Halo D7T20282CTRecalls & reported problems
Biosense Webster Inc · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10846835005981), received between Aug 22, 2022 and Aug 22, 2022 — classified as 1 injury.
The most frequently reported specific device problem is “Patient Device Interaction Problem” (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.
Most reported problems
Device problems
- Patient Device Interaction Problem1
Patient problems
- Cardiac Arrest1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 22, 2022Patient Device Interaction Problem; Patient Device Interaction Problem
IT WAS REPORTED THAT A 66-YEAR-OLD MALE PATIENT UNDERWENT A AFIB ¿ PAROXYSMAL ABLATION PROCEDURE WITH A HALO¿ XP ELECTROPHYSIOLOGY CATHETER WITH AUTO ID AND THE PATIENT SUFFERED A CARDIAC ARREST REQUIRING CARDIOPULMONARY RESUSCITATION (CPR). IT WAS REPORTED THAT WHILE PERFORMING A CAVOTRICUSPID ISHMUS (CTI) LINE, THE HALO¿ XP ELECTROPHYSIOLOGY CATHETER WITH AUTO ID POTENTIALLY FLIPPED INTO THE RIGHT VENTRICLE TEMPORARILY CAUSING THE RIGHT VENTRICLE (RV) PACEMAKER LEAD TO DISLODGE. THE PATIENT IS PACEMAKER DEPENDENT AND LOST PACING FROM THE LEAD. CPR WAS PERFORMED BRIEFLY, AND THE PACEMAKER LEAD STARTED PACING AGAIN ON ITS OWN. THE BWI REPRESENTATIVE DESCRIBED IT AS A MICRO-DISLODGEMENT AND STATED THAT NO FURTHER INTERVENTION WAS PLANNED AT THAT TIME. THE PHYSICIAN BELIEVES THAT THE ADVERSE EVENT WAS A CAUSE OF A COMBINATION OF A PROCEDURAL EVENT AND PATIENT CONDITION. THE PATIENT¿S CONDITION IMPROVED; THEY WERE EXTUBATED AND DISCHARGED THE FOLLOWING MORNING WITH NO LEAD REVISION NEEDED. THE PATIENT DID REQUIRE EXTENDED HOSPITALIZATION. THEY WERE ADMITTED AND SPENT ONE NIGHT IN THE INTENSIVE CARE UNIT (ICU). PATIENT HAD NORMAL ELECTROLYTE LEVELS. ADDITIONAL INFORMATION RECEIVED INDI
Patient problems: Cardiac Arrest
MAUDE report 15272487 ↗
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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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