SafireRecalls & reported problems across all models
St. Jude Medical Cardiovascular Division · 5 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 31
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls
- 0
We found 5 models of Safire by St. Jude Medical Cardiovascular Division in the FDA's device registry (GUDID). Together they are named in 31 adverse event reports in the FDA's MAUDE database, received between Jul 24, 2019 and Aug 28, 2025 — classified as 5 injuries, 26 malfunctions.
The most frequently reported specific device problem is “Signal Artifact/Noise” (11 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Safire problems
Device problems
- Signal Artifact/Noise11
- High impedance6
- Adverse Event Without Identified Device or Use Problem4
- Failure to Deliver Energy3
- Activation, Positioning or Separation Problem2
- Communication or Transmission Problem2
- Material Twisted/Bent2
- Overheating of Device2
Patient problems
- No Clinical Signs, Symptoms or Conditions26
- Heart Block2
- Arrhythmia1
- Cardiac Perforation1
- Complete Heart Block1
Safire models
5 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Safire™ 402810Cardiac ablation percutaneous catheter12 reports
- Safire™ 402811Cardiac ablation percutaneous catheter9 reports
- Safire™ 402807Cardiac ablation percutaneous catheter7 reports
- Safire™ 402806Cardiac ablation percutaneous catheter2 reports
- Safire™ 402808Cardiac ablation percutaneous catheter1 report
Recent Safire adverse event reports
The 15 most recent reports across all models, 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 ↗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 ↗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 ↗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 ↗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
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 ↗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 ↗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 ↗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 ↗
Other St. Jude Medical Cardiovascular Division products
All St. Jude Medical Cardiovascular Division devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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