EnSite™ ENSITE-FF-4.5C-01Recalls & reported problems
St. Jude Medical, Inc. · Field Frame Cable · Class 2
All models of EnSite (37)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05415067032232), received between Oct 23, 2025 and Nov 10, 2025 — classified as 2 malfunctions.
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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Material Twisted/Bent1
- Thermal Decomposition of Device1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 10, 2025Thermal Decomposition of Device; Thermal Decomposition of Device
DURING PREPARATION FOR AN ATRIAL FIBRILLATION PROCEDURE, THE FIELD FRAME WAS PLUGGED IN INCORRECTLY, AND AFTER THIS THE CABLE AND PLUG OF THE FIELD FRAME WAS BURNED. THE FIELD FRAME AND FIELD FRAME CABLE WERE REPLACED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23513567 ↗MalfunctionOct 23, 2025Material Twisted/Bent; Material Twisted/Bent
DURING AN ATRIAL FIBRILLATION PROCEDURE, THERE WAS A COMMUNICATION ISSUE WITH THE AMPLIFIER AND A BENT PIN ON THE FIELD FRAME CABLE RESULTING IN CANCELLATION OF THE PROCEDURE. THE FIELD FRAME GENERATOR WAS NOT ABLE TO CONNECT TO THE AMPLIFIER. DESPITE MULTIPLE RESTARTS OF THE AMPLIFIER AND DISPLAY WORKSTATION, AND AFTER VERIFYING ALL CONNECTIONS, IT WAS FOUND THAT ONE OF THE PINS ON THE FIELD FRAME CABLE WAS BROKEN. THE CABLE AND FIELD FRAME WERE EXCHANGED BUT THE ISSUE DID NOT RESOLVE. THE SYSTEM WAS SWITCHED TO NAVX MODE, HOWEVER THE CATHETERS WERE NOT VISIBLE. IT IS ALLEGED THAT THE AMPLIFIER WAS CAUSING THE ISSUE. DUE TO THE ISSUE NOT BEING RESOLVED, THE PROCEDURE WAS CANCELLED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23376241 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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