Advisor™ VL, Sensor Enabled™ D-AVSE-D10-V1525Recalls & reported problems
St. Jude Medical, Inc. · Circular Mapping Catheter · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05415067027252), received between Jul 28, 2023 and Mar 11, 2024 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Fracture” (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
- Adverse Event Without Identified Device or Use Problem1
- Fracture1
Patient problems
- Cardiac Perforation1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryMar 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
RELATED MANUFACTURING REFERENCE: 3008452825-2024-00135. DURING THE PULMONARY VEIN ISOLATION PROCEDURE, A CARDIAC TAMPONADE OCCURRED WHICH REQUIRED A PERICARDIOCENTESIS TO STABILIZE THE PATIENT. THE PROCEDURE WAS BEING PERFORMED WITH ENSITE X SYSTEM IN VOXEL MODE. TWO CATHETERS WERE IN THE LEFT ATRIUM FOR MAPPING AND ABLATION. DURING MAPPING, THE TAMPONADE OCCURRED, IT WAS UNCLEAR THE CAUSE BUT MOST PROBABLY THE LEFT ATRIAL APPENDAGE WAS PERFORATED. A PERICARDIOCENTESIS WAS PERFORMED, THE PATIENT STABILIZED AND WAS ADMITTED TO THE ICU FOR OBSERVATION.
Patient problems: Cardiac Perforation
MAUDE report 18881842 ↗MalfunctionJul 28, 2023Fracture; Fracture
DURING THE ATRIAL FIBRILATION PROCEDURE, IT WAS NOTED THAT THE CATHETER WAS DIFFICULT TO ROTATE DURING THE MODELING PROCESS. THE CATHETER WAS WITHDRAWN FROM THE HEART AND THE FRONT END OF THE CATHETER WAS FRACTURED. THE DEVICE WAS REPLACED, AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT. THERE WAS NO NOTICEABLE ABNORMALITY OF THE CATHETER AFTER OPENING THE PACKAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17417731 ↗
Other CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING devices
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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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