Safire™ 402811Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 05414734206020), received between Sep 30, 2021 and May 23, 2025 — classified as 1 injury, 8 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (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. 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryMay 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A SUPRAVENTRICULAR TACHYCARDIA PROCEDURE, A HEART BLOCK OCCURRED REQUIRING A PERMANENT PACEMAKER TO RESOLVE. A SLOW PATHWAY AND 2 ECHO BEATS WERE SEEN INITIALLY. A BRIEF RUN OF SUPRAVENTRICULAR TACHYCARDIA WAS INDUCED WITH A LEFT LATERAL CONCEALED PATHWAY. THE CORONARY SINUS 1-2 SHOWED THE EARLIEST RETROGRADE A. DURING ABLATION OF THE SLOW PATHWAY FOR ATRIOVENTRICULAR NODAL REENTRANT TACHYCARDIA, THE LESION PROVIDED MULTIPLE CONSECUTIVE SLOW JUNCTIONAL BEATS, TWO RAPID ATRIAL BEATS THEN COMPLETE HEART BLOCK. RF OFF WAS CALLED IMMEDIATELY WHEN THE 2 RAPID BEATS OCCURRED. AFTER WAITING FOR 30 MINUTES WITHOUT ANY RESOLUTION TO SINUS RHYTHM A PERMANENT DUAL CHAMBER PACEMAKER WAS PLACED. THE PATIENT WAS STABLE.

  Patient problems: Heart Block

  MAUDE report 22075730 ↗
• MalfunctionMay 13, 2024Failure to Deliver Energy; Failure to Deliver Energy

  DURING AN ATRIAL TACHYCARDIA PROCEDURE, THE CATHETER DID NOT POWER UP. ANOTHER CATHETER OF THE SAME TYPE WAS USED WHICH DID NOT RESOLVE THE ISSUE. A CONTACT FORCE CATHETER WAS THEN USED TO COMPLETE THE PROCEDURE WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19300758 ↗
• MalfunctionApr 29, 2024Signal Artifact/Noise; Signal Artifact/Noise

  DURING AN ATRIOVENTRICULAR NODAL REENTRANT TACHYCARDIA PROCEDURE, IT WAS NOTED THAT THERE WAS NOISE ON THE SAFIRE BI-DIRECTIONAL ABLATION CATHETER. THE CABLE WAS REPLACED TWICE BUT WITH NO RESOLUTION. THE SAFIRE BI-DIRECTIONAL ABLATION CATHETER WAS EXCHANGED BUT NOISE WAS ALSO NOTED ON THE SECOND SAFIRE BI-DIRECTIONAL ABLATION CATHETER. THE SECOND SAFIRE BI-DIRECTIONAL ABLATION CATHETER WAS EXCHANGED FOR TACTIFLEX SE ABLATION CATHETER AND THE PROCEDURE WAS ABLE TO BE COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19205572 ↗
• MalfunctionMay 15, 2023Electrical Shorting; Electrical Shorting

  THIS REPORT IS TO ADVISE OF A SHORT CIRCUIT NOTED DURING ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16935424 ↗
• MalfunctionMar 22, 2023Signal Artifact/Noise; Overheating of Device; Signal Artifact/Noise; Overheating of Device

  RELATED MANUFACTURING REFERENCE: 2182269-2023-00016. DURING A PAROXYSMAL SUPRAVENTRICULAR TACHYCARDIA (PSVT) PROCEDURE, THE GENERATOR SHOWED THE CATHETER TEMPERATURE AS HIGH. THE CABLE WAS EXCHANGED WITH NO RESOLUTION. THE CATHETER WAS EXCHANGED BUT THE HIGH TEMPERATURE ISSUE WAS NOT RESOLVED AND NOISE WAS ALSO NOTED. THE CATHETER WAS EXCHANGED TO A THIRD ONE AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCE TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16591508 ↗
• MalfunctionMar 22, 2023Overheating of Device; Overheating of Device

  RELATED MANUFACTURING REFERENCE: 2182269-2023-00017. DURING A PAROXYSMAL SUPRAVENTRICULAR TACHYCARDIA (PSVT) PROCEDURE, THE GENERATOR SHOWED THE CATHETER TEMPERATURE AS HIGH. THE CABLE WAS EXCHANGED WITH NO RESOLUTION. THE CATHETER WAS EXCHANGED BUT THE HIGH TEMPERATURE ISSUE WAS NOT RESOLVED AND NOISE WAS ALSO NOTED. THE CATHETER WAS EXCHANGED TO A THIRD ONE AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCE TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16591505 ↗
• MalfunctionFeb 28, 2023Impedance Problem; Impedance Problem

  RELATED MANUFACTURING REFERENCE: 3008452825-2023-00049 AND 3008452825-2023-00050. DURING THE AFL PROCEDURE, WHILE USING ENSITE X IN NAVX, IMPEDANCE AND DISPLAY ISSUES WERE NOTED WHICH CAUSED DELAYS TO TREATMENT. THE PROCEDURE WAS COMPLETED USING A NON-ABBOTT CATHETER (BLAZER 8MM) AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT. DURING THE PROCEDURE, IT WAS NOTED AFTER 15 SECONDS OF ABLATING AT 30W THAT THE IMPEDANCE SPIKED TO 532 AND THEN TO 999 OHMS AND THAT THE CATHETER APPEARED DISTORTED AND TURNED RED ON THE SYSTEM. THE FOLLOWING TROUBLESHOOTING WAS DONE WITH NO RESOLUTION: CHECKING THE PHYSICAL CONNECTION BETWEEN THE GROUNDING PADS AND PATIENT'S BODY, CHECKING THAT THE GROUNDS WERE STILL PLUGGED INTO THE AMPERE GENERATOR, REPLACING THE FLEXABILITY SE CABLE, REPLACING THE FLEXABILITY SE CATHETER, REPLACING THE FLEXABILITY CATHETER, REPLACING THE SAFIRE CATHETER, REPLACING THE GENERATOR, REPLACING THE POWER CABLE AND PLUGGING DIRECTLY INTO THE HOSPITAL GROUNDED PLUG RECEPTACLE, POWER CYCLING BOTH AMPERE GENERATORS, RECONNECTING THE GROUNDING PAD CABLES FROM BOTH GENERATORS., PUTTING A NEW NON-ABBOTT GROUNDING PAD (MACROLYTE) IN A NEW LOCATION, PUTTING

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16453789 ↗
• MalfunctionSep 30, 2021Material Twisted/Bent; Material Twisted/Bent

  MANUFACTURER REPORT NUMBER: 2182269-2021-00076. DURING AN AV NODAL REENTRY TACHYCARDIA (AVNRT) PROCEDURE, THE CATHETER TIP WAS NOTED TO BE BENT PRIOR TO ABLATION. THE CATHETER WAS REPLACED, HOWEVER, THE SECOND CATHETER WAS ALSO BENT, BUT NOT INSERTED INTO THE PATIENT. A THIRD CATHETER WAS USED TO COMPLETE THE PROCEDURE WITHOUT ANY CONSEQUENCES TO THE PATIENT. A PROCEDURE DELAY OCCURRED DUE TO THESE ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12555786 ↗
• MalfunctionSep 30, 2021Material Twisted/Bent; Material Twisted/Bent

  MANUFACTURER REPORT NUMBER: 2182269-2021-00075. DURING AN AV NODAL REENTRY TACHYCARDIA (AVNRT) PROCEDURE, THE CATHETER TIP WAS NOTED TO BE BENT PRIOR TO ABLATION. THE CATHETER WAS REPLACED, HOWEVER, THE SECOND CATHETER WAS ALSO BENT, BUT NOT INSERTED INTO THE PATIENT. A THIRD CATHETER WAS USED TO COMPLETE THE PROCEDURE WITHOUT ANY CONSEQUENCES TO THE PATIENT. A PROCEDURE DELAY OCCURRED DUE TO THESE ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12555766 ↗

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