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EnSite Precision™ H702470Recalls & reported problems

St. Jude Medical, Inc. · Module · Class 2

Data updated Oct 16, 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 05415067024701), received between Mar 29, 2019 and Jul 29, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Sparking” (2 reports).

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

  • Sparking2

Patient problems

  • No Clinical Signs, Symptoms or Conditions1
  • No Consequences Or Impact To Patient1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJul 29, 2021Sparking; Sparking

    DURING DEVICE PREPARATION, WHEN POWERED ON, SPARKING WAS NOTED. THE SYSTEM WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE PATIENT CONSEQUENCES.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12247785 ↗
  • MalfunctionMar 29, 2019Sparking; Sparking

    DURING DEVICE PREPARATION, THE 4-PIN CONNECTOR OF THE POWER SUPPLY CABLE WAS NOTED TO BE UNCOVERED AND A SPARK WAS NOTED WHEN PLUGGED INTO THE SOCKET. THE DEVICE WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8463525 ↗

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Sources and updates

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