Agilis™ NxT Steerable Introducer Dual-Reach™ SI-1371-MRecalls & reported problems

Summary

The FDA's MAUDE database contains 301 adverse event reports that list this exact device (DI 05415067051851), received between Mar 20, 2025 and Sep 30, 2026 — classified as 1 death, 25 injuries, 275 malfunctions.

The most frequently reported specific device problem is “Gas/Air Leak” (189 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, 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 25 most recent of 301 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Unspecified Heart Problem

  MAUDE report 50953714 ↗
• MalfunctionSep 29, 2026Gas/Air Leak

  During the atrial fibrillation procedure, an air leak was noted on the Agilis sheath after insertion of the Volt catheter. After inserting the Volt catheter into the Agilis sheath, air intake was observed several times. The Agilis sheath was exchanged, and the procedure was completed with no adverse patient health consequences.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50935693 ↗
• MalfunctionSep 28, 2026Fluid/Blood Leak; Gas/Air Leak

  During a procedure, air was aspirated from the Agilis 13F sheath and blood was dripping out of the dilator. When inserting the non-Abbott (Boston Scientific Farawave) catheter, more air was aspirated and blood was dripping from the hemostasis valve. The sheath was exchanged, and the procedure was completed with no adverse patient consequences.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50916460 ↗
• MalfunctionSep 23, 2026Gas/Air Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50873884 ↗
• MalfunctionSep 17, 2026Fluid/Blood Leak; Gas/Air Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50808729 ↗
• MalfunctionAug 24, 2026Difficult to Insert; Gas/Air Leak

  During an atrial fibrillation procedure, an air leak was noted on the hemostasis valve of the Agilis sheath after Volt catheter insertion. Prior to Volt catheter insertion, it was noted that there was increased resistance requiring more force than normal when inserting the dilator into the Agilis sheath. After the Volt catheter was inserted, an air leak was noted to be coming from the hemostasis valve. The Agilis sheath was exchanged, and the procedure was completed with no adverse patient health consequences.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50410996 ↗
• MalfunctionAug 6, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50159157 ↗
• MalfunctionJul 30, 2026Difficult to Insert; Gas/Air Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50083426 ↗
• InjuryJul 13, 2026Difficult to Insert

  DURING AN ATRIAL FIBRILLATION PROCEDURE, IT WAS NOTED THAT THE ILIAC VEIN WAS PERFORATED WHICH RESULTED IN A BALLOON BEING PLACED TO SEAL THE PERFORATION. ACCESS WAS GAINED IN BOTH THE RIGHT AND LEFT FEMORAL VEINS. THE CS CATHETER WAS INSERTED THROUGH THE LEFT FEMORAL VEIN WITH NO ISSUE AND POSITIONED IN THE CORONARY SINUS. AN ICE CATHETER WAS INSERTED THROUGH THE RIGHT FEMORAL VEIN ACCESS INTO THE RA WITH NO ISSUE. THE AMPLATZ SUPER STIFF 0.035¿ WIRE WAS INSERTED THROUGH THE RIGHT FEMORAL VEIN INTO THE SVC WITH NO ISSUE EITHER. THE SHORT SHEATH WAS REMOVED FROM THE RIGHT FEMORAL ACCESS AND AN AGILIS 13F WITH THE DILATOR OVER THE WIRE WAS ADVANCED. WHILE ADVANCING, RESISTANCE WAS MET. A FEW ATTEMPTS WERE MADE TO MANEUVER PAST THE RESISTANCE WITH NO RESOLUTION. THE AMPLATZ WIRE, AGILIS 13F, AND DILATOR WERE REMOVED FROM THE PATIENT. AFTER WITHDRAWING, THE RESISTANCE WAS MET AGAIN. ICE WAS USED TO VISUALIZE THE AREA OF RESISTANCE IN THE GROIN. THE ICE CATHETER WAS REMOVED, AND THE SHORT SHEATH WAS INSERTED AGAIN. CONTRAST WAS INSERTED THROUGH THE RIGHT FEMORAL SHEATH UNDER FLUOROSCOPY. CONTRAST WAS SEEN EXITING THE OUT THE RIGHT SIDE OF THE RIGHT ILIAC VEIN INTO THE EXTRA-VENOUS SPAC

  Patient problems: Unspecified Tissue Injury

  MAUDE report 25798398 ↗
• MalfunctionJun 29, 2026Activation, Positioning or Separation Problem

  THIS REPORT IS TO ADVISE OF A DISPLACEMENT OF THE PULL RING AT THE TIP OF THE SHEATH. DURING A PFA ATRIAL FIBRILLATION ABLATION PROCEDURE USING VOLT 2.0, THE AGILIS SHEATH SUDDENLY LOST DEFLECTION WHILE PROBING THE RIGHT INFERIOR PULMONARY VEIN. THE SHEATH WAS REPLACED, AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25656913 ↗
• MalfunctionJun 25, 2026Gas/Air Leak

  DURING A PULSED FIELD ABLATION PULMONARY VEINS ISOLATION PROCEDURE, AIR ASPIRATED FROM THE AGILIS 13F SHEATH. TRANSSEPTAL ACCESS WAS PERFORMED WITH AGILIS 13F SHEATH. THE LEFT ATRIUM WAS MAPPED WITH AN ADVISOR HD GRID X CATHETER, WHICH WAS THEN SWAPPED OUT FOR A VOLT CATHETER. AFTER THE VOLT CATHETER WAS INSERTED INTO THE AGILIS 13F, ASPIRATION WAS ATTEMPTED BUT AIR ENTERED THE SYRINGE. THE AGILIS 13F SHEATH WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25623392 ↗
• MalfunctionJun 17, 2026Gas/Air Leak

  DURING A PFA/AF PROCEDURE, AIR ASPIRATED FROM THE SHEATH AFTER THE VOLT CATHETER WAS INSERTED. THE SHEATH WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25535683 ↗
• MalfunctionJun 15, 2026Fluid/Blood Leak

  DURING AN ATRIAL FIBRILLATION PROCEDURE, THE AGILIS M 13F SHEATH WAS NOTED TO BE LEAKING BLOOD FROM THE END OF THE SHEATH AT THE VALVE AFTER REMOVING THE DILATOR WHILE IN THE LEFT ATRIUM. THE SHEATH WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25505857 ↗
• MalfunctionJun 8, 2026Material Puncture/Hole; Material Twisted/Bent

  DURING A PVI PROCEDURE, THE NEEDLE PUNCTURED THE DILATOR. WHEN ATTEMPTING TRANSSEPTAL PUNCTURE, IT WAS NOTED THAT THE DILATOR WAS BENT. WHEN THE NEEDLE WAS INSERTED, IT PUNCTURED THE DILATOR. THE SHEATH AND NEEDLE WERE REPLACED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT. THE STYLET WAS USED WITH THE NEEDLE AND NO ADDITIONAL PUNCTURE SITE WAS NEEDED. HOWEVER, THE NEEDLE WAS RESHAPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25429998 ↗
• InjuryJun 5, 2026Adverse Event Without Identified Device or Use Problem

  DURING AN ATRIAL FIBRILLATION PROCEDURE, FOLLOWING TRANSSEPTAL PUNCTURE, WHEN THE ADVISOR HD GRID CATHETER WAS ADVANCED THROUGH THE AGILIS SHEATH AND INTO THE LEFT ATRIUM, TRANSIENT ST ELEVATION OCCURRED. THE ST ELEVATION SELF RESOLVED WITH NO INTERVENTION REQUIRED AND THE PROCEDURE WAS COMPLETED WITH NO FURTHER ISSUES. THERE WERE NO ALLEGED PERFORMANCE ISSUES WITH ANY DEVICES.

  Patient problems: Arrhythmia

  MAUDE report 25403329 ↗
• InjuryJun 5, 2026Adverse Event Without Identified Device or Use Problem

  DURING AN ATRIAL FIBRILLATION PROCEDURE, FOLLOWING TRANSSEPTAL PUNCTURE, WHEN THE ADVISOR HD GRID CATHETER WAS ADVANCED THROUGH THE AGILIS SHEATH AND INTO THE LEFT ATRIUM, TRANSIENT ST ELEVATION OCCURRED. THE ST ELEVATION SELF RESOLVED WITH NO INTERVENTION REQUIRED AND THE PROCEDURE WAS COMPLETED WITH NO FURTHER ISSUES. THERE WERE NO ALLEGED PERFORMANCE ISSUES WITH ANY DEVICES.

  Patient problems: Arrhythmia

  MAUDE report 25403328 ↗
• InjuryJun 4, 2026Adverse Event Without Identified Device or Use Problem

  DURING A PFA/PVI PROCEDURE, A PERICARDIAL EFFUSION WAS NOTED FROM A PERFORATION WITH ECHO. CARDIAC INTERVENTION WAS PERFORMED TO PATCH UP THE HOLE. THE PHYSICIAN ALLEGES THAT THE PERICARDIAL PUNCTURE OCCURRED WITH THE AGILIS AND GUIDEWIRE AT THE LAA. THE PROCEDURE WAS ABANDONED. THERE WERE NO INSERTION OR REMOVAL DIFFICULTIES NOTED WITH THE GUIDEWIRE OR THE SHEATH. ACT WAS AROUND 300. THE PATIENT IS RECOVERING. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICE.

  Patient problems: Cardiac Perforation

  MAUDE report 25402512 ↗
• MalfunctionJun 4, 2026Gas/Air Leak

  DURING AN ATRIAL FIBRILLATION PROCEDURE, THE VOLT CATHETER INTO THE SHEATH AND WHILE ASPIRATING, AIR BUBBLES WERE OBSERVED. SEVERAL ATTEMPTS WERE MADE TO CLEAR THE AIR, BUT THE ISSUE PERSISTED. THE SHEATH WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25398088 ↗
• MalfunctionJun 2, 2026Activation, Positioning or Separation Problem

  THIS REPORT IS TO ADVISE OF A DISPLACEMENT OF THE PULL RING AT THE DISTAL END OF THE SHEATH. DURING THE PFA/AF PROCEDURE, TWO VEINS HAD BEEN ISOLATION WHEN DEFLECTION STOPPED WHILE ATTEMPTING TO ACCESS THE RIGHT INFERIOR PULMONARY VEIN. DUE TO SUPPLY DIFFICULTIES WITH VOLT CATHETERS, THE CATHETER WAS REPLACED WITH A TACTICATH CATHETER AND THE AGILIS 13F WAS REPLACED WITH A SHEATH TO GO WITH THE TACTICATH. THE REMAINING TWO VEINS WERE ISOLATED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25367441 ↗
• MalfunctionJun 2, 2026Activation, Positioning or Separation Problem

  THIS REPORT APPLIES TO THE AGILIS INTRODUCER THAT EXPERIENCED THE STEERING / DEFLECTION ISSUE AND IS TO ADVISE OF A DISPLACEMENT OF THE PULL RING AT THE DISTAL END OF THE SHEATH. DURING AN ATRIAL FIBRILLATION PFA PROCEDURE, IT WAS NOTED TO BE DIFFICULT TO REACH THE RIGHT INFERIOR PULMONARY VEINS (RIPV). ALL 3 OTHER VEINS WERE TARGETED WITH EASE. THE PHYSICIAN NOTED THAT THE SHEATH STOPPED STEERING AS EXPECTED, THINKING THE PULL WIRE MAY BE BROKEN. THE SHEATH WAS REPLACED AND THE CATHETER AND NON-ABBOTT GUIDEWIRE (STARTER GUIDEWIRE BY BOSTON SCIENTIFIC) WERE ALSO REMOVED. THE PROCEDURE WAS FINISHED WITHOUT ABLATION IN THE RIPV. THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25367437 ↗
• MalfunctionJun 2, 2026Activation, Positioning or Separation Problem

  THIS REPORT IS TO ADVISE OF A DISPLACEMENT OF THE PULL RING AT THE DISTAL END OF THE SHEATH. DURING THE AF PROCEDURE WITH VOLT, IT WAS NOTED THAT THE AGILIS COULD NO LONGER BE MANEUVERED AFTER ABLATING 3 OF THE 4 VEINS. TO FINISH ABLATING THE RIGHT INFERIOR PULMONARY VEIN, A TACTIFLEX CATHETER WAS USED TO COMPLETE THE PROCEDURE AS THERE WAS NO REPLACEMENT AGILIS ON HAND TO USE WITH THE VOLT CATHETER. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25366854 ↗
• MalfunctionJun 2, 2026Gas/Air Leak

  DURING AN ATRIAL FIBRILLATION PROCEDURE, AIR ASPIRATED FROM THE SHEATH AFTER THE VOLT CATHETER WAS INSERTED. ASPIRATION WAS ATTEMPTED AGAIN WITH NO RESOLUTION. THE SHEATH WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25358570 ↗
• MalfunctionMay 26, 2026Material Puncture/Hole

  DURING AN ATRIAL FIBRILLATION PROCEDURE, THE NEEDLE PUNCTURED THE DILATOR. THE AGILIS WAS ADVANCED INTO THE RA OVER THE GUIDEWIRE WITH THE DILATOR INSERTED. THE GUIDEWIRE WAS THEN EXCHANGED FOR THE BRK NEEDLE. FLUOROSCOPY SHOWED THAT THE NEEDLE WAS STICKING OUT THE SIDE OF THE AGILIS DILATOR. THE WHOLE SYSTEM WAS REMOVED AND EXCHANGED. THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25281143 ↗
• MalfunctionMay 25, 2026Gas/Air Leak

  DURING THE ATRIAL FIBRILLATION PFA PROCEDURE, AIR INGRESS WAS OBSERVED WHILE FLUSHING WHICH DID NOT SUBSIDE DESPITE REPEATED ATTEMPTS. THE SHEATH WAS REPLACED WHICH RESOLVED THE ISSUE. THE PROCEDURE WAS COMPLETED WITH NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25273180 ↗
• MalfunctionMay 23, 2026Difficult to Insert

  DURING A PVI PFA PROCEDURE, COMMUNICATION AND POSITIONING ISSUES RESULTED IN THE CANCELLATION OF THE PROCEDURE. AFTER A FEW PFA DELIVERIES, IT WAS NOTED THAT ELECTRODE 3 TURNED INVALID (YELLOW) AND DID NOT TURN BACK, EVEN AFTER RESETTING THE BASELINE. AFTER A WHILE THE SAME HAPPENED WITH ELECTRODE 7. IT WAS ALSO NOTED THAT THE PULL MECHANISM ON THE SHEATH STOPPED WORKING. THE CATHETER AND SHEATH WERE REPLACED BUT THE SECOND CATHETER DID NOT COLLECT ANY GEOMETRY AND IT WAS NOT POSSIBLE TO ADVANCE THE CATHETER OUT OF THE SHEATH WITHOUT EXTRA FORCE. THE PHYSICIAN STOPPED THE PROCEDURE AT THIS POINT. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25264492 ↗