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EnSite Precision™ H702469Recalls & reported problems

St. Jude Medical, Inc. · Field Frame · Class 2

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 05415067024695), received between Feb 17, 2023 and Feb 17, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Communication or Transmission 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

  • Communication or Transmission Problem1

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 17, 2023Communication or Transmission Problem; Communication or Transmission Problem

    RELATED MANUFACTURING REFERENCE: 2184149-2023-00022. DURING THE SVT ABLATION PROCEDURE, IT WAS NOTED THAT THERE WAS NO MAGNETIC LOCATION WHICH CAUSED DELAYS TO TREATMENT. A PRECISION LINK AND FIELD FRAME FROM A SECOND SYSTEM WERE USED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16397797 ↗

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Sources and updates

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