Safire™ 402810Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 05414734206013), received between Jul 24, 2019 and Aug 28, 2025 — classified as 3 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Signal Artifact/Noise” (7 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 18, 2026.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryAug 28, 2025High impedance; High impedance

  DURING A SVT LEFT LATERAL ACCESSORY PATHWAY PROCEDURE, THE PATIENT WENT INTO VT/AFIB REQUIRING CARDIOVERSION AND TRANSSEPTAL ACCESS WAS LOST RESULTING IN CANCELLATION OF THE PROCEDURE. AFTER INSERTING THE SAFIRE CATHETER, HIGH IMPEDANCE WAS OBSERVED. WHEN ABLATION CAME ON, IT WOULD SPIKE FOR ONE SECOND AND THEN DROP TO ALMOST NOTHING. A NEW CABLE AND GROUNDING PAD WERE ADDED BUT NO RESOLVE. WHEN PULLING THE SHEATH AND CATHETER BACK TO SWAP FOR A NEW SAFIRE CATHETER, THE PATIENT WENT INTO VT / AFIB AND TRANSSEPTAL ACCESS WAS LOST. THE SHEATH AND CATHETER WERE THEN PULLED INTO THE RIGHT ATRIUM. IT IS ALLEGED THAT ONCE THE SHEATH WAS PULLED BACK, THE CATHETER WAS STICKING OUT OF THE SHEATH AND MADE CONTACT WITH THE HEART CAUSING THE VT/AFIB, NOT THE IMPEDANCE ISSUES. THE PATIENT WAS CARDIOVERTED AND STABILIZED. TRANSSEPTAL ACCESS WAS THEN UNABLE TO BE REOBTAINED. GETTING TRANSSEPTAL ACCESS WAS ALSO DIFFICULT INITIALLY DUE TO THE SIZE OF THE HEART. ANOTHER CATH DOCTOR WAS CALLED IN ORIGINALLY TO ASSIST AS THE PATIENT WAS ALSO HEMODYNAMICALLY UNSTABLE.

  Patient problems: Arrhythmia

  MAUDE report 22910229 ↗
• MalfunctionApr 3, 2025Communication or Transmission Problem; Communication or Transmission Problem

  DURING A SUPRAVENTRICULAR TACHYCARDIA PROCEDURE, A COMMUNICATION ISSUE OCCURRED CAUSING A PROCEDURE DELAY. AN ERROR MESSAGE WAS NOTED ON THE AMPERE GENERATOR STATING THAT THE CATHETER WAS NOT CONNECTED (DESPITE THE CATHETER BEING VISUALIZED WITH GOOD SIGNAL QUALITY) AND ABLATION WAS NOT POSSIBLE. THE CABLE AND GENERATOR WERE EXCHANGED WHICH DID NOT RESOLVE THE ISSUE. THE CATHETER WAS THEN EXCHANGED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21766254 ↗
• MalfunctionOct 29, 2024Signal Artifact/Noise; Signal Artifact/Noise

  RELATED MANUFACTURING REFERENCE: (B)(4). DURING THE SUPRAVENTRICULAR TACHYCARDIA PROCEDURE, SIGNAL ISSUES WITH THE CATHETERS RESULTED IN A PROCEDURAL DELAY. IT WAS NOTED THAT THE CATHETER WAS NOISY ON THE ENSITE X. THE CABLE WAS EXCHANGED, WITH NO RESOLUTION. THE CATHETER WAS EXCHANGED, BUT THE ISSUE PERSISTED. THE CATHETER WAS THEN EXCHANGED AGAIN, AND THE ISSUE WAS RESOLVED TO COMPLETE THE PROCEDURE WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20557693 ↗
• MalfunctionOct 29, 2024Signal Artifact/Noise; Signal Artifact/Noise

  RELATED MANUFACTURING REFERENCE: (B)(4). DURING THE SUPRAVENTRICULAR TACHYCARDIA PROCEDURE, SIGNAL ISSUES WITH THE CATHETERS RESULTED IN A PROCEDURAL DELAY. IT WAS NOTED THAT THE CATHETER WAS NOISY ON THE ENSITE X. THE CABLE WAS EXCHANGED, WITH NO RESOLUTION. THE CATHETER WAS EXCHANGED, BUT THE ISSUE PERSISTED. THE CATHETER WAS THEN EXCHANGED AGAIN, AND THE ISSUE WAS RESOLVED TO COMPLETE THE PROCEDURE WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20557246 ↗
• MalfunctionSep 30, 2024Signal Artifact/Noise; High impedance; Signal Artifact/Noise; High impedance

  RELATED MANUFACTURE REF: 2182269-2024-00033. DURING A WOLFF PARKINSON WHITE (WPW) PROCEDURE, NOISE WAS NOTED CAUSING A DELAY IN PROCEDURE. DURING THE PROCEDURE, A REPROCESSED NON-ABBOTT (BARD) CATHETER DID NOT DISPLAY ELECTRODES 1 AND 10 ACCURATELY ON THE MAPPING SYSTEM. THE CABLE WAS REPLACED, WITHOUT RESOLUTION. A SAFIRE ABLATION CATHETER WAS INSERTED INTO THE RIGHT ATRIUM AND THE GENERATOR WAS TURNED ON.; NOISE WAS NOTED ON ELECTRODE PAIRS 1-2 AND 9-10 ON BOTH THE MAPPING AND RECORDING SYSTEMS. ADDITIONALLY, THE IMPEDANCE READING ON THE GENERATOR WAS 215 OHMS, HIGHER THAN EXPECTED. THE GROUNDING PAD WAS SWAPPED TO A SECONDARY INPUT PORT ON THE GENERATOR WITH NO RESOLVE. A NEW GROUNDING PAD WAS PLACED ON THE PATIENT AND PLUGGED INTO ONE OF THE INPUT PORTS ON THE GENERATOR; IMPEDANCE WAS STILL HIGH. THE GROUNDING PAD WAS SWAPPED TO THE OTHER PORT WHICH DID NOT RESOLVE THE ISSUE. THE CABLE FOR THE ABLATION CATHETER WAS EXCHANGED WITH NO RESOLVE. THE GENERATOR WAS POWER CYCLED WITH NO RESOLVE. BOTH GROUNDING PADS WERE PLUGGED IN WITH NO RESOLVE. THE CATHETER WAS EXCHANGED FOR A NEW ONE, WITHOUT RESOLUTION. WHENEVER THE GENERATOR WAS POWERED OFF, THE EGM ARTIFACTS CLEARED UP AND THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20335216 ↗
• MalfunctionSep 30, 2024Signal Artifact/Noise; High impedance; Signal Artifact/Noise; High impedance

  RELATED MANUFACTURE REFERENCE: 2182269-2024-00032. DURING A WOLFF PARKINSON WHITE (WPW) PROCEDURE, NOISE WAS NOTED CAUSING A DELAY IN PROCEDURE. DURING THE PROCEDURE, A REPROCESSED NON-ABBOTT (BARD) CATHETER DID NOT DISPLAY ELECTRODES 1 AND 10 ACCURATELY ON THE MAPPING SYSTEM. THE CABLE WAS REPLACED, WITHOUT RESOLUTION. A SAFIRE ABLATION CATHETER WAS INSERTED INTO THE RIGHT ATRIUM AND THE GENERATOR WAS TURNED ON.; NOISE WAS NOTED ON ELECTRODE PAIRS 1-2 AND 9-10 ON BOTH THE MAPPING AND RECORDING SYSTEMS. ADDITIONALLY, THE IMPEDANCE READING ON THE GENERATOR WAS 215 OHMS, HIGHER THAN EXPECTED. THE GROUNDING PAD WAS SWAPPED TO A SECONDARY INPUT PORT ON THE GENERATOR WITH NO RESOLVE. A NEW GROUNDING PAD WAS PLACED ON THE PATIENT AND PLUGGED INTO ONE OF THE INPUT PORTS ON THE GENERATOR; IMPEDANCE WAS STILL HIGH. THE GROUNDING PAD WAS SWAPPED TO THE OTHER PORT WHICH DID NOT RESOLVE THE ISSUE. THE CABLE FOR THE ABLATION CATHETER WAS EXCHANGED WITH NO RESOLVE. THE GENERATOR WAS POWER CYCLED WITH NO RESOLVE. BOTH GROUNDING PADS WERE PLUGGED IN WITH NO RESOLVE. THE CATHETER WAS EXCHANGED FOR A NEW ONE, WITHOUT RESOLUTION. WHENEVER THE GENERATOR WAS POWERED OFF, THE EGM ARTIFACTS CLEARED UP AN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20335112 ↗
• MalfunctionMay 13, 2024Failure to Deliver Energy; Failure to Deliver Energy

  THIS REPORT INCLUDES CORRECTED MANUFACTURING SITE INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19300675 ↗
• InjuryOct 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING AN ATRIOVENTRICULAR NODAL RE-ENTRY PROCEDURE A HEART BLOCK OCCURRED. DURING ONE OF THE RF APPLICATIONS, THE ABLATION CATHETER WAS NOTED TO HAVE RISEN INTO THE FAST PATHWAY AREA AND HEART BLOCK WAS OBSERVED. CONDUCTION QUICKLY RECOVERED AND ANOTHER RF APPLICATION WAS APPLIED TO THE SLOW PATHWAY LOCATION. AFTER THE APPLICATION, THE CATHETER SWUNG THROUGH THE HIS ZONE AND HEART BLOCK WAS ONCE AGAIN OBSERVED. THIS TIME 2:1 HEART BLOCK THAT RECOVERED TO MOBITZ TYPE 1 AND THEN IT RECOVERED TO 1:1. THE PATIENT WAS GIVEN A TEMPORARY PACING WIRE AND SENT TO THE FLOOR FOR OBSERVATION AND THEN WAS GIVEN A PERMANENT PACEMAKER IMPLANT A FEW DAYS LATER.

  Patient problems: Heart Block

  MAUDE report 15541387 ↗
• MalfunctionFeb 25, 2022Signal Artifact/Noise; Signal Artifact/Noise

  DURING AN ATRIOVENTRICULAR NODAL REENTRANT TACHYCARDIA PROCEDURE, DUE TO A NOISE ISSUE AND THE TROUBLESHOOTING INVOLVED, A PROLONGED PROCEDURE OCCURRED. INITIALLY THE CABLE AND GENERATOR WERE EXCHANGED, BUT THE ISSUE REMAINED. THE CATHETER WAS THEN EXCHANGED AND THE ISSUE WAS RESOLVED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13599005 ↗
• MalfunctionDec 28, 2021Signal Artifact/Noise; Signal Artifact/Noise

  RELATED MANUFACTURING REF: 2182269-2021-00095. DURING AN ATRIOVENTRICULAR NODAL REENTRANT TACHYCARDIA (AVNRT) SLOW PATHWAY ABLATION PROCEDURE, NOISE WAS NOTED ON THE CATHETER. THE CABLES, AMPLIFIER AND CATHETER WERE EXCHANGED WITH NO RESOLUTION. ANOTHER CATHETER WAS USED TO COMPLETE THE PROCEDURE WITH NO CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13095132 ↗
• MalfunctionDec 28, 2021Signal Artifact/Noise; Signal Artifact/Noise

  RELATED MANUFACTURING REF: 2182269-2021-00096. DURING AN ATRIOVENTRICULAR NODAL REENTRANT TACHYCARDIA (AVNRT) SLOW PATHWAY ABLATION PROCEDURE, NOISE WAS NOTED ON THE CATHETER. THE CABLES, AMPLIFIER AND CATHETER WERE EXCHANGED WITH NO RESOLUTION. ANOTHER CATHETER WAS USED TO COMPLETE THE PROCEDURE WITH NO CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13095126 ↗
• InjuryJul 24, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURING REFERENCE: 3008452825-2019-00358, 2182269-2019-00100, 3008452825-2019-00359, 2030404-2019-00058. DURING A PULMONARY VEIN CONTRACTION (PVC) ABLATION PROCEDURE A PERICARDIAL EFFUSION OCCURRED. FOLLOWING ABLATION OF THE RIGHT CORONARY CUSP, THE USER ATTEMPTED A SECOND PVC IN THE LEFT VENTRICLE (LV) THROUGH THE CORONARY SINUS (CS). A FLEXABILITY CATHETER WAS USED FIRST THROUGH AN AGILIS SHEATH BUT THERE WAS NO SUCCESS IN REACHING THE TARGET SITE. A SAFIRE CATHETER WAS THEN ATTEMPTED BUT IT WAS DECIDED THE ANATOMY OF THE PATIENT WAS TOO DIFFICULT TO PLACE A CATHETER OUT DISTALLY IN THE CS. THE USER DECIDED TO FORGO FURTHER ABLATION AND PROCEEDED WITH AN EP STUDY. DURING THE EP STUDY THE PATIENT BECAME HYPOTENSIVE AND ECHOCARDIOGRAPHY CONFIRMED FLUID IN THE PERICARDIUM NECESSITATING A PERICARDIOCENTESIS. ONCE STABILIZED THE PATIENT WAS TRANSFERRED OUT OF THE OR. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICE.

  Patient problems: Cardiac Perforation

  MAUDE report 8821457 ↗

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