Safire™ TX 402841Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05414734300179), received between Apr 24, 2019 and Apr 24, 2019 — classified as 1 injury.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryApr 24, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING AN ATRIAL FIBRILLATION ABLATION PROCEDURE A CARDIAC PERFORATION OCCURRED. FOLLOWING ABLATION OF THE CAVO-TRICUSPID ISTHMUS LINE WITH A SAFIRE ABLATION CATHETER, A CONTACT FORCE CATHETER WAS USED TO ABLATE THE PULMONARY VEINS (PVS). WHILE ABLATING THE PVS, THE GRAMS OF FORCE WAS INTERMITTENTLY DISPLAYED AND THE FTI VALUES WERE NOT DISPLAYED AT ALL. THE CATHETER WAS EXCHANGED TO RESOLVE THE ISSUE WHEN A CARDIAC PERFORATION WAS NOTED. TRANSESOPHAGEAL ECHOCARDIOGRAPHY CONFIRMED THE PERFORATION TO BE ON THE RIGHT SIDE OF THE HEART WHERE THE FIRST ABLATION CATHETER WAS USED. A PERICARDIOCENTESIS WAS PERFORMED TO STABILIZE THE PATIENT. THE ABLATION PROCEDURE WAS NOT CONTINUED. THERE WERE NO PERFORMANCE ISSUES ALLEGED AGAINST THE FIRST ABLATION CATHETER.

  Patient problems: Cardiac Perforation

  MAUDE report 8545641 ↗

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-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-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-0309-2007 · Nov 8, 2006 · Terminated
  Endologix Infrarenal Bifurcated Powerlink System with Visifiex Delivery System (endovascular graft). Model Number 25-16-155BL
• Z-0310-2007 · Nov 8, 2006 · Terminated
  Endologix Infrarenal Bifurcated Powerlink System with Visifiex Delivery System (endovascular graft), Model Number 28-16-155BL