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Sensor Enabled™ CableRecalls & reported problems

St. Jude Medical, Inc. · Ablation Connection Cable · Class 3

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 05415067024916), received between Mar 5, 2021 and Mar 7, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Communication or Transmission Problem” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Communication or Transmission Problem2

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.

  • MalfunctionMar 7, 2021Communication or Transmission Problem; Communication or Transmission Problem

    RELATED MANUFACTURER REF: 2184149-2021-00055, 2030404-2021-00013, 3008452825-2021-00100, 3008452825-2021-00099, 3005334138-2021-00133. DURING A CHRONIC ATRIAL FIBRILLATION ABLATION PROCEDURE, MULTIPLE ISSUES SURROUNDING COMMUNICATION, IMPEDANCE, AND PHYSICAL CONNECTION, OCCURRED THAT RESULTED IN A CLINICALLY SIGNIFICANT DELAY. TROUBLESHOOTING INCLUDED CATHETER, CATHETER CONNECTING CABLE, AND TUBING SET EXCHANGES, IN ADDITIONAL TO REBOOTING OF THE GENERATOR. THE PROCEDURE WAS ULTIMATELY STILL ABLE TO BE COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11426300 ↗
  • MalfunctionMar 5, 2021Communication or Transmission Problem; Communication or Transmission Problem

    RELATED MANUFACTURER REF: 2184149-2021-00055, 2030404-2021-00013, 3008452825-2021-00100, 3008452825-2021-00099, 3005334138-2021-00134. DURING A CHRONIC ATRIAL FIBRILLATION ABLATION PROCEDURE, MULTIPLE ISSUES SURROUNDING COMMUNICATION, IMPEDANCE, AND PHYSICAL CONNECTION, OCCURRED THAT RESULTED IN A CLINICALLY SIGNIFICANT DELAY. TROUBLESHOOTING INCLUDED CATHETER, CATHETER CONNECTING CABLE, AND TUBING SET EXCHANGES, IN ADDITIONAL TO REBOOTING OF THE GENERATOR. THE PROCEDURE WAS ULTIMATELY STILL ABLE TO BE COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11426247 ↗

Other catheter, percutaneous, cardiac ablation, for treatment of atrial flutter devices

All catheter, percutaneous, cardiac ablation, for treatment of atrial flutter devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.