Safire™ 402806Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05414734205979), received between Nov 9, 2021 and Nov 9, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Communication or Transmission Problem” (1 report).

1 other recall cover devices cleared under the same FDA submission (P960016); they may or may not involve this specific model.

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

Recent adverse event reports

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

• MalfunctionNov 9, 2021High impedance; High impedance

  RELATED MANUFACTURER REF: 2182269-2021-00089. DURING AN ATRIOVENTRICULAR NODAL REENTRANT TACHYCARDIA ABLATION PROCEDURE, A PROLONGED PROCEDURE OCCURRED. INITIALLY WHEN ATTEMPTING TO ABLATE, TWO SECONDS OF RADIOFREQUENCY ENERGY WAS DELIVERED AND THEN THE AMPERE GENERATOR STOPPED. THE AMPERE SCREEN DISPLAYED "NO CATHETER CONNECTED". THE CATHETER CONNECTING CABLE WAS RECONNECTED ON BOTH ENDS, BUT THE ISSUE REMAINED. THE CONNECTING CABLE WAS EXCHANGED, WHICH RESOLVED THE ISSUE TEMPORARILY, BUT THEN THE ISSUE REOCCURRED. THE AMPERE GENERATOR WAS REPLACED, BUT THE ISSUE REMAINED. THE CATHETER WAS EXCHANGED AND IT WAS POSSIBLE TO THEN DELIVER ENERGY, BUT THEN A HIGH IMPEDANCE ISSUE WAS NOTED. A NON-ABBOTT GENERATOR WAS SWITCHED TO IN ADDITION TO A NON-ABBOTT ABLATION CATHETER AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12782817 ↗
• MalfunctionNov 9, 2021Communication or Transmission Problem; Communication or Transmission Problem

  RELATED MANUFACTURER REF: 2182269-2021-00090. DURING AN ATRIOVENTRICULAR NODAL REENTRANT TACHYCARDIA ABLATION PROCEDURE, A PROLONGED PROCEDURE OCCURRED. INITIALLY WHEN ATTEMPTING TO ABLATE, TWO SECONDS OF RADIOFREQUENCY ENERGY WAS DELIVERED AND THEN THE AMPERE GENERATOR STOPPED. THE AMPERE SCREEN DISPLAYED "NO CATHETER CONNECTED". THE CATHETER CONNECTING CABLE WAS RECONNECTED ON BOTH ENDS, BUT THE ISSUE REMAINED. THE CONNECTING CABLE WAS EXCHANGED, WHICH RESOLVED THE ISSUE TEMPORARILY, BUT THEN THE ISSUE REOCCURRED. THE AMPERE GENERATOR WAS REPLACED, BUT THE ISSUE REMAINED. THE CATHETER WAS EXCHANGED AND IT WAS POSSIBLE TO THEN DELIVER ENERGY, BUT THEN A HIGH IMPEDANCE ISSUE WAS NOTED. A NON-ABBOTT GENERATOR WAS SWITCHED TO IN ADDITION TO A NON-ABBOTT ABLATION CATHETER AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12782812 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P960016. One submission often covers many models, so check the product and lot details in each record.

• Z-2313-2008 · Jun 5, 2008 · Terminated
  The St. Jude Medical Livewire TC" Ablation Catheter, 8mm Tip w/Thermocouple & Thermistor REF 402196, Length 115 cm, Lot 2056960, Manufacturer St. Jude Medical 14901 DeVeau Place, M