Safire™ 402807Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 05414734205986), received between Jul 28, 2022 and Mar 19, 2025 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (2 reports).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 19, 2025Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  RELATED MANUFACTURING REF: 2182269-2025-00005. DURING A PAROXYSMAL SUPRAVENTRICULAR TACHYCARDIA PROCEDURE, THE CATHETERS COULD NOT BE STRAIGHTENED CAUSING A PROCEDURE DELAY. WHEN BENDING THE CATHETER, IT COULD NOT BE STRAIGHTENED. THE CATHETER WAS REPLACED AND THE SAME ISSUE OCCURRED. A THIRD CATHETER WAS USED TO COMPLETE THE PROCEDURE WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21641758 ↗
• MalfunctionMar 19, 2025Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  RELATED MANUFACTURING REF: 2182269-2025-00004. DURING A PAROXYSMAL SUPRAVENTRICULAR TACHYCARDIA PROCEDURE, THE CATHETERS COULD NOT BE STRAIGHTENED CAUSING A PROCEDURE DELAY. WHEN BENDING THE CATHETER, IT COULD NOT BE STRAIGHTENED. THE CATHETER WAS REPLACED AND THE SAME ISSUE OCCURRED. A THIRD CATHETER WAS USED TO COMPLETE THE PROCEDURE WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21641739 ↗
• MalfunctionMay 1, 2024Signal Artifact/Noise; Signal Artifact/Noise

  DURING THE ATRIOVENTRICULAR NODAL REENTRANT TACHYCARDIA (AVNRT) PROCEDURE, SIGNAL ISSUES RESULTED IN A PROCEDURAL DELAY. WHEN THE CATHETER WAS INSERTED INTO THE PATIENT, NOISE WAS NOTED ON THE DISTAL ELECTRODE AND WAS PRESENT ON BOTH THE ENSITE SYSTEM AND THE NON-ABBOTT SYSTEM (GE RECORDING SYSTEM). THE CABLE WAS REPLACED BUT THE ISSUE WAS NOT RESOLVED. THE CATHETER WAS REPLACED WITH ANOTHER SAFIRE BI-DIRECTIONAL ABLATION CATHETER, BUT THE ISSUE PERSISTED. THE SECOND CATHETER WAS REPLACED WITH A TACTICATH SE ABLATION CATHETER WHICH RESOLVED THE ISSUE. THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19226047 ↗
• MalfunctionMay 1, 2024Signal Artifact/Noise; Signal Artifact/Noise

  DURING THE ATRIOVENTRICULAR NODAL REENTRANT TACHYCARDIA (AVNRT) PROCEDURE, SIGNAL ISSUES RESULTED IN A PROCEDURAL DELAY. WHEN THE CATHETER WAS INSERTED INTO THE PATIENT, NOISE WAS NOTED ON THE DISTAL ELECTRODE AND WAS PRESENT ON BOTH THE ENSITE SYSTEM AND THE NON-ABBOTT SYSTEM (GE RECORDING SYSTEM). THE CABLE WAS REPLACED BUT THE ISSUE WAS NOT RESOLVED. THE CATHETER WAS REPLACED WITH ANOTHER SAFIRE BI-DIRECTIONAL ABLATION CATHETER, BUT THE ISSUE PERSISTED. THE SECOND CATHETER WAS REPLACED WITH A TACTICATH SE ABLATION CATHETER WHICH RESOLVED THE ISSUE. THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19225969 ↗
• MalfunctionNov 23, 2022Failure to Deliver Energy; High impedance; Failure to Deliver Energy; High impedance

  RELATED MANUFACTURING REFERENCE: 2182269-2022-00063. DURING THE SVT PROCEDURE, IT WAS NOTED THAT THE CATHETER DISPLAYED A HIGH IMPEDANCE. THE DEVICE WAS REPLACED, AND LOW NO POWER AND HIGH IMPEDANCE WERE NOTED. THE DEVICE WAS REPLACED A SECOND TIME, AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15852690 ↗
• MalfunctionNov 23, 2022High impedance; High impedance

  RELATED MANUFACTURING REFERENCE: 2182269-2022-00064. DURING THE SVT PROCEDURE, IT WAS NOTED THAT THE CATHETER DISPLAYED A HIGH IMPEDANCE. THE DEVICE WAS REPLACED, AND LOW NO POWER AND HIGH IMPEDANCE WERE NOTED. THE DEVICE WAS REPLACED A SECOND TIME, AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15852673 ↗
• MalfunctionJul 28, 2022Use of Device Problem; Use of Device Problem

  DURING THE ATRIAL TACHYCARDIA PROCEDURE, AN EXPIRED DEVICE WAS USED. THERE WAS NO PERFORMANCE ISSUES NOTED AND THERE WAS NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15118647 ↗

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