FlexAbility™ A701124Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05415067011107), received between Jun 27, 2018 and May 30, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (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

Recent adverse event reports

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

• MalfunctionMay 30, 2023Fracture; Fracture

  DURING THE PREMATURE VENTRICULAR CONTRACTION PROCEDURE, THE CATHETER WAS CONNECTED WITH THE ENSITE PRECISION SYSTEM BUT IT WAS NOTED THE SIGNAL DID NOT APPEAR. THE CATHETER WIRE, THE AMPERE, AND THE OPTICAL FIBER WERE CHECKED BUT THIS DID NOT RESOLVE THE ISSUE. THE CATHETER WAS REMOVED AND THE HEAD END WAS NOTED TO BE FRACTURED. THE CATHETER WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITHOUT ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17021013 ↗
• MalfunctionJun 27, 2018Fluid/Blood Leak; Fluid/Blood Leak

  DURING A PREMATURE VENTRICULAR CONTRACTION, THE CATHETER'S HANDLE WAS LEAKING DURING ABLATION AND THE GENERATOR DISPLAYED A HIGH TEMPERATURE ERROR MESSAGE. THE CATHETER WAS EXCHANGED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7642690 ↗