Safire™ TX 402840Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 05414734300162), received between Aug 27, 2018 and Jun 27, 2025 — classified as 3 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Communication or Transmission Problem” (3 reports).

4 other recalls cover devices cleared under the same FDA submission (P040042); 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 27, 2025Communication or Transmission Problem; Material Twisted/Bent; Communication or Transmission Problem; Material Twisted/Bent

  DURING AN ATRIAL FLUTTER PROCEDURE, THE CATHETER WAS NOT RECOGNIZED BY THE SYSTEM AND COULD NOT DELIVER RF ENERGY CAUSING A DELAY IN PROCEDURE. ALL HARDWARE AND SOFTWARE TROUBLESHOOTING WERE DONE, WITH NO RESOLUTION. THE CATHETER WAS REMOVED FROM THE PATIENT, AND THE TIP OF THE CATHETER APPEARED BENT AND INCORRECT. THE CATHETER WAS EXCHANGED AND THERE WERE NO ADVERSE PATIENT HEALTH CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22344855 ↗
• MalfunctionMar 11, 2024Communication or Transmission Problem; Communication or Transmission Problem

  RELATED MANUFACTURING REFERENCE: 2030404-2024-00015. DURING AN ATRIOVENTRICULAR NODAL REENTRANT TACHYCARDIA (AVNRT) CASE, COMMUNICATION ISSUES WITH THE CATHETERS RESULTED IN A PROCEDURAL DELAY. THE CATHETER DID NOT REGISTER ON THE AMPERE GENERATOR AND NO SIGNALS OR PROPER DISPLAY OF THE CATHETER WAS SEEN ON THE ENSITE X OR ON THE NON-ABBOTT RECORDING SYSTEM (GE). ALL THE CONNECTIONS WERE CHECKED TO ENSURE PROPER HOOK-UP, THE CATHETER CONNECTION CABLE WAS CHANGED, THE GEN CONNECT CABLE WAS CHANGED, THE GENERATOR WAS EXCHANGED, THE CATHETER WAS EXCHANGED, AND THE SYSTEM WAS POWER CYCLED. THE ISSUE WAS NOT RESOLVED, THE NEW CATHETER DID NOT REGISTER IN THE GENERATOR AS BEING CONNECTED AND NO SIGNALS OR CATHETER DISPLAY WAS SEEN. THIS SECOND CATHETER WAS EXCHANGED FOR A TACTICATH SE ABLATION CATHETER AND THE ISSUE WAS RESOLVED. THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18874800 ↗
• MalfunctionMar 11, 2024Communication or Transmission Problem; Communication or Transmission Problem

  RELATED MANUFACTURING REFERENCE: 2030404-2024-00016. DURING AN ATRIOVENTRICULAR NODAL REENTRANT TACHYCARDIA (AVNRT) CASE, COMMUNICATION ISSUES WITH THE CATHETERS RESULTED IN A PROCEDURAL DELAY. THE CATHETER DID NOT REGISTER ON THE AMPERE GENERATOR AND NO SIGNALS OR PROPER DISPLAY OF THE CATHETER WAS SEEN ON THE ENSITE X OR ON THE NON-ABBOTT RECORDING SYSTEM (GE). ALL THE CONNECTIONS WERE CHECKED TO ENSURE PROPER HOOK-UP, THE CATHETER CONNECTION CABLE WAS CHANGED, THE GEN CONNECT CABLE WAS CHANGED, THE GENERATOR WAS EXCHANGED, THE CATHETER WAS EXCHANGED, AND THE SYSTEM WAS POWER CYCLED. THE ISSUE WAS NOT RESOLVED, THE NEW CATHETER DID NOT REGISTER IN THE GENERATOR AS BEING CONNECTED AND NO SIGNALS OR CATHETER DISPLAY WAS SEEN. THIS SECOND CATHETER WAS EXCHANGED FOR A TACTICATH SE ABLATION CATHETER AND THE ISSUE WAS RESOLVED. THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18874747 ↗
• MalfunctionJan 25, 2024Impedance Problem; Impedance Problem

  RELATED MANUFACTURING REFERENCE: 2030404-2024-00004. DURING AN AV NODE ABLATION PROCEDURE, IMPEDANCE ISSUES REQUIRED MULTIPLE TROUBLESHOOTING MEASURES WITHOUT RESOLVING THE ISSUE AND THE PROCEDURE WAS CANCELLED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT. IT WAS NOTED THAT THE ABLATION CATHETER WAS NOT DELIVERING ENERGY DUE TO "IMPEDANCE OUT OF RANGE" ERROR ON THE AMPERE. THE IMPEDANCE WAS AROUND 48-50OHMS. WE HAD TWO GROUNDING PADS ON THE PATIENT LOCATED ON HIS LEFT SCAPULA AND SECOND ONE UNDERNEATH. WE CHANGED CABLES (BOTH WERE REPROCESSED), BUT THE ISSUE WAS NOT RESOLVED. WE CHANGED THE LOCATION OF THE GROUNDING PADS, ONE LEFT FOOT AND ONE ON THE BACK BUT STILL COULD NOT ABLATE. THE CATHETER WAS EXCHANGED BUT THE SAME ISSUE OCCURRED SO WE USED TWO GROUNDS ON THE LEGS TO INCREASE IMPEDANCE UP TO 68-70 OHMS. WE WERE ABLE TO DELIVER ENERGY FROM AMPERE BUT NOTHING WAS HAPPENING REGARDING ABLATING THE AV NODE SO THE PHYSICIAN DECIDED TO STOP BECAUSE WE WEREN'T SURE OF THE AMOUNT OF ENERGY DELIVERY NOR WHERE IT IS GOING. PATIENT STATUS IS GOOD AND THE PROCEDURE WILL BE RESCHEDULED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18582513 ↗
• MalfunctionJan 25, 2024Impedance Problem; Impedance Problem

  RELATED MANUFACTURING REFERENCE: (B)(4).   DURING AN AV NODE ABLATION PROCEDURE, IMPEDANCE ISSUES REQUIRED MULTIPLE TROUBLESHOOTING MEASURES WITHOUT RESOLVING THE ISSUE AND THE PROCEDURE WAS CANCELLED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT. IT WAS NOTED THAT THE ABLATION CATHETER WAS NOT DELIVERING ENERGY DUE TO "IMPEDANCE OUT OF RANGE" ERROR ON THE AMPERE. THE IMPEDANCE WAS AROUND 48-50OHMS. WE HAD TWO GROUNDING PADS ON THE PATIENT LOCATED ON HIS LEFT SCAPULA AND SECOND ONE UNDERNEATH. WE CHANGED CABLES (BOTH WERE REPROCESSED), BUT THE ISSUE WAS NOT RESOLVED. WE CHANGED THE LOCATION OF THE GROUNDING PADS, ONE LEFT FOOT AND ONE ON THE BACK BUT STILL COULD NOT ABLATE. THE CATHETER WAS EXCHANGED BUT THE SAME ISSUE OCCURRED SO WE USED TWO GROUNDS ON THE LEGS TO INCREASE IMPEDANCE UP TO 68-70 OHMS. WE WERE ABLE TO DELIVER ENERGY FROM AMPERE BUT NOTHING WAS HAPPENING REGARDING ABLATING THE AV NODE SO THE PHYSICIAN DECIDED TO STOP BECAUSE WE WEREN'T SURE OF THE AMOUNT OF ENERGY DELIVERY NOR WHERE IT IS GOING. PATIENT STATUS IS GOOD AND THE PROCEDURE WILL BE RESCHEDULED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18582499 ↗
• InjuryOct 13, 2020Failure to Analyze Signal; Failure to Analyze Signal

  DURING AN AV NODE ABLATION PROCEDURE, SIGNAL DID NOT APPEAR FOR THE ABLATION CATHETER. THE CATHETER WAS EXCHANGED WITH NO SUCCESS. TECH SUPPORT WAS CALLED, AND THE ISSUE REMAINED AFTER CHECKING THE CABLES AND CONNECTIONS. THE CATHETER WAS EXCHANGED WITH A NON-ABBOTT CATHETER TO COMPLETE THE PROCEDURE WITH NO ADVERSE PATIENT CONSEQUENCES. HOWEVER, THERE WAS A 45 MINUTE DELAY DUE TO THE ISSUE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10669281 ↗
• InjuryOct 13, 2020Failure to Analyze Signal; Failure to Analyze Signal

  DURING AN AV NODE ABLATION PROCEDURE, SIGNAL DID NOT APPEAR FOR THE ABLATION CATHETER. THE CATHETER WAS EXCHANGED WITH NO SUCCESS. TECH SUPPORT WAS CALLED, AND THE ISSUE REMAINED AFTER CHECKING THE CABLES AND CONNECTIONS. THE CATHETER WAS EXCHANGED WITH A NON-ABBOTT CATHETER TO COMPLETE THE PROCEDURE WITH NO ADVERSE PATIENT CONSEQUENCES. HOWEVER, THERE WAS A 45 MINUTE DELAY DUE TO THE ISSUE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10669278 ↗
• InjuryAug 27, 2018No Display/Image; No Display/Image

  RELATED MANUFACTURING REF: 2184149-2018-00138. DURING AN ATRIAL VENTRICULAR NODE ABLATION, THE ABLATION SIGNALS AND RADIOFREQUENCY DATA WERE UNABLE TO BE SEEN FROM THE AMPERE GENERATOR AND THE PROCEDURE WAS CANCELLED. THE CABLES WERE RECONNECTED, THE GENERATOR SELECTION WAS VERIFIED, AND THE PATCHES WERE CONFIRMED TO BE CONNECTED TO THE PATIENT WITH NO RESOLUTION. THE PROCEDURE WAS CANCELLED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7819776 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P040042. One submission often covers many models, so check the product and lot details in each record.

• Z-0593-2010 · Nov 25, 2009 · Terminated
  Powerlink System with IntuiTrak Delivery System (Endovascular Graft): Model Number 34-34-80L, LOTS W09-2966 AND W09-2998.
• Z-0594-2010 · Nov 25, 2009 · Terminated
  Powerlink System with IntuiTrak Delivery System (Endovascular Graft): Model Number 34-34-80LE, LOTS W09-2967 AND W09-3000.
• Z-0310-2007 · Nov 8, 2006 · Terminated
  Endologix Infrarenal Bifurcated Powerlink System with Visifiex Delivery System (endovascular graft), Model Number 28-16-155BL
• Z-0309-2007 · Nov 8, 2006 · Terminated
  Endologix Infrarenal Bifurcated Powerlink System with Visifiex Delivery System (endovascular graft). Model Number 25-16-155BL