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FlexAbility™ A701159Recalls & reported problems

St. Jude Medical, Inc. · Ablation Catheter · Class 3

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05415067011510), received between Feb 10, 2021 and Feb 10, 2021 — classified as 1 injury.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Improper or Incorrect Procedure or Method1
  • Obstruction of Flow1

Patient problems

  • Embolism/Embolus1
  • Thrombosis/Thrombus1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryFeb 10, 2021Improper or Incorrect Procedure or Method; Obstruction of Flow; Improper or Incorrect Procedure or Method; Obstruction of Flow

    DURING A PROCEDURE, AN OBSTRUCTION WAS NOTED DUE TO A CLOT. UPON CLOSER INSPECTION, IT WAS DETERMINED THAT THE IRRIGATION VALVE WAS CLOSED AND LIQUID COULD NOT IRRIGATE PROPERLY. THIS HAPPENED AT THE START OF THE PROCEDURE, WITHOUT ANY RADIOFREQUENCY ABLATION APPLICATION PERFORMED. THE CATHETER WAS REMOVED AND A NEW ONE WAS USED TO CONTINUE THE PROCEDURE WITH NO CONSEQUENCES TO THE PATIENT.

    Patient problems: Embolism/Embolus; Thrombosis/Thrombus

    MAUDE report 11311577 ↗

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.