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

Summary

The FDA's MAUDE database contains 151 adverse event reports that list this exact device (DI 05415067050182), received between Mar 6, 2025 and Sep 30, 2026 — classified as 18 injuries, 133 malfunctions.

The most frequently reported specific device problem is “Gas/Air Leak” (89 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 151 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50952427 ↗
• MalfunctionSep 28, 2026Fluid/Blood Leak; Gas/Air Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50924874 ↗
• MalfunctionSep 28, 2026Gas/Air Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50917641 ↗
• MalfunctionSep 24, 2026Gas/Air Leak

  During a pulsed field ablation atrial fibrillation procedure, air was aspirated from the Agilis 13F sheath upon insertion of the Volt catheter. The catheter was removed and the Agilis sheath was aspirated with no issue. A second attempt to insert the Volt catheter was made, but the issue was not resolved. The sheath was exchanged for a second Agilis 13F sheath, but upon insertion of the Volt catheter, air was aspirated. An additional attempt was made to insert to the catheter, but the issue was not resolved. The Volt catheter was exchanged, but the issue was not resolved. The sheath was exchanged for a third Agilis 13F sheath, and the procedure was completed with no adverse consequences to the patient.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50885504 ↗
• MalfunctionSep 24, 2026Gas/Air Leak

  During a pulsed field ablation atrial fibrillation procedure, air was aspirated from the Agilis 13F sheath upon insertion of the Volt catheter. The catheter was removed and the Agilis sheath was aspirated with no issue. A second attempt to insert the Volt catheter was made, but the issue was not resolved. The sheath was exchanged for a second Agilis 13F sheath, but upon insertion of the Volt catheter, air was aspirated. An additional attempt was made to insert to the catheter, but the issue was not resolved. The Volt catheter was exchanged, but the issue was not resolved. The sheath was exchanged for a third Agilis 13F sheath, and the procedure was completed with no adverse consequences to the patient.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50885488 ↗
• MalfunctionAug 4, 2026Activation, Positioning or Separation Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50132551 ↗
• MalfunctionJul 1, 2026Improper or Incorrect Procedure or Method; Gas/Air Leak

  DURING AN ATRIAL FIBRILLATION PROCEDURE, AN AIR LEAK WAS NOTED ON THE AGILIS SHEATH AFTER INSERTION OF THE VOLT CATHETER. THE VOLT CATHETER WAS INSERTED AFTER TRANSSEPTAL PUNCTURE, AND THE AIR LEAK WAS NOTED WHILE ASPIRATING THE AGILIS SHEATH. THE AGILIS SHEATH WAS EXCHANGED, AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE PATIENT HEALTH CONSEQUENCES. THE AGILIS SHEATH WAS IRRIGATED USING A PRESSURE BAG, WHICH GOES AGAINST THE DEVICE INSTRUCTIONS FOR USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25677018 ↗
• MalfunctionJun 23, 2026Gas/Air Leak

  DURING A PULSED FIELD ABLATION PROCEDURE, AN AIR LEAK WAS NOTED ON THE AGILIS 13F SHEATH AFTER THE NON-ABBOTT DEVICE (FARAWAVE) WAS INSERTED. THE AGILIS 13F SHEATH WAS EXCHANGED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25597946 ↗
• MalfunctionJun 9, 2026Gas/Air Leak

  DURING AN ATRIAL FIBRILLATION PROCEDURE, AN AIR LEAK WAS NOTED WHEN THE VOLT CATHETER WAS INSERTED INTO THE AGILIS SHEATH. THE VOLT CATHETER WAS REMOVED, AND THE AGILIS SHEATH WAS ASPIRATED WITH BLOOD RETURN. THE VOLT CATHETER WAS EXCHANGED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE PATIENT HEALTH CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25447689 ↗
• InjuryJun 9, 2026Device Contamination with Body Fluid

  DURING THE PFA PROCEDURE, A CLOT WAS OBSERVED IN THE SHEATH WHEN REMOVING THE ADVISOR HD GRID CATHETER FROM THE LEFT ATRIUM TO SWITCH TO THE NON-ABBOTT (FARAWAVE) CATHETER. THE SHEATH WAS ASPIRATED AND THE CLOT WAS REMOVED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING THE SAME SHEATH. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 25446489 ↗
• MalfunctionMay 29, 2026Fluid/Blood Leak

  DURING A PVI ATRIAL FIBRILLATION PROCEDURE, PERSISTENT BLOOD BACKFLOW WAS OBSERVED FROM THE AGILIS SHEATH. DESPITE APPLYING A WATER SEAL, THE BLOOD LEAKAGE CONTINUED UPON INSERTION OF AN ADVISOR HD GRID X CATHETER. AS THE PROCEDURE WAS IN THE 'POST MAP' STAGE, THE SHEATH WAS NOT EXCHANGED, AND THE CASE WAS COMPLETED WITHOUT ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25331570 ↗
• InjuryMay 22, 2026Adverse Event Without Identified Device or Use Problem

  DURING AN ATRIAL FIBRILLATION PROCEDURE, THE SHEATH WITH THE DILATOR WAS INSERTED INTO THE PATIENT¿S BODY USING THE WIRE SUPPLIED WITH FARAWAVE NAV, AND RESISTANCE WAS NOTED IN THE BLOOD VESSEL. THEREFORE, THE SHEATH ALONG WITH THE DILATOR WAS WITHDRAWN COMPLETELY FROM THE PATIENT. WHEN CHECKING THE DEVICE, THE TIP OF THE DILATOR WAS FOUND TO BE BENT. WHEN INSERTING THE SECOND AGILIS 13FR INTO THE PATIENT'S BODY, RESISTANCE WAS NOTED IN THE BLOOD VESSEL AGAIN. WHEN CONTRAST IMAGING WAS PERFORMED THROUGH THE SHEATH¿S FLUSH PORT, DISSECTION OF THE FEMORAL VEIN WAS NOTED. THE AGILIS WAS LEFT IN PLACE FOR HEMOSTASIS, AND THE REPLACEMENT SHEATH WAS INSERTED THROUGH THE CONTRALATERAL FEMORAL VEIN TO PERFORM THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH NO FURTHER ISSUES. AFTER COMPLETION OF THE PROCEDURE, AND REMOVAL OF THE SHEATH, CONTRAST IMAGING WAS PERFORMED AGAIN, AND IT WAS CONFIRMED THAT THERE WAS NO ENLARGEMENT OF THE DISSECTION OR HEMATOMA, SO THE PATIENT WAS RETURNED TO RECOVERY WITHOUT INTERVENTION NEEDED AND HAS SINCE BEEN DISCHARGED. THERE WERE NO ALLEGED PERFORMANCE ISSUES WITH ANY ABBOTT DEVICES.

  Patient problems: Vascular Dissection

  MAUDE report 25250930 ↗
• InjuryMay 22, 2026Material Twisted/Bent

  DURING AN ATRIAL FIBRILLATION PROCEDURE, THE SHEATH WITH THE DILATOR WAS INSERTED INTO THE PATIENT¿S BODY USING THE WIRE SUPPLIED WITH FARAWAVE NAV, AND RESISTANCE WAS NOTED IN THE BLOOD VESSEL. THEREFORE, THE SHEATH ALONG WITH THE DILATOR WAS WITHDRAWN COMPLETELY FROM THE PATIENT. WHEN CHECKING THE DEVICE, THE TIP OF THE DILATOR WAS FOUND TO BE BENT. WHEN INSERTING THE SECOND AGILIS 13FR INTO THE PATIENT'S BODY, RESISTANCE WAS NOTED IN THE BLOOD VESSEL AGAIN. WHEN CONTRAST IMAGING WAS PERFORMED THROUGH THE SHEATH¿S FLUSH PORT, DISSECTION OF THE FEMORAL VEIN WAS NOTED. THE AGILIS WAS LEFT IN PLACE FOR HEMOSTASIS, AND THE REPLACEMENT SHEATH WAS INSERTED THROUGH THE CONTRALATERAL FEMORAL VEIN TO PERFORM THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH NO FURTHER ISSUES. AFTER COMPLETION OF THE PROCEDURE, AND REMOVAL OF THE SHEATH, CONTRAST IMAGING WAS PERFORMED AGAIN, AND IT WAS CONFIRMED THAT THERE WAS NO ENLARGEMENT OF THE DISSECTION OR HEMATOMA, SO THE PATIENT WAS RETURNED TO RECOVERY WITHOUT INTERVENTION NEEDED AND HAS SINCE BEEN DISCHARGED. THERE WERE NO ALLEGED PERFORMANCE ISSUES WITH ANY ABBOTT DEVICES.

  Patient problems: Vascular Dissection

  MAUDE report 25250913 ↗
• MalfunctionMay 19, 2026Fluid/Blood Leak

  DURING AN ATRIAL FIBRILLATION PROCEDURE, THERE WAS A BLOOD LEAK NOTED FROM THE VALVE ON THE AGILIS 13 FR SHEATH. THE BLOOD LEAK WAS NOTED AFTER INSERTING THE DILATOR INTO THE AGILIS 13 FR SHEATH. THE AGILIS 13 FR SHEATH WAS EXCHANGED, AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE PATIENT HEALTH CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25212130 ↗
• MalfunctionMay 15, 2026Fluid/Blood Leak

  DURING A PULSED FIELD ABLATION PROCEDURE, A BACKFLOW OF BLOOD WAS OBSERVED FROM THE HEMOSTATIC VALVE OF THE AGILIS SHEATH. THE DILATOR HAD BEEN INSERTED THROUGH THE AGILIS 13F SHEATH, AND THE ASSEMBLY WAS ADVANCED OVER A NON-ABBOTT (BAYLIS/BOSTON SCIENTIFIC) VERSACROSS TRANSSEPTAL WIRE. AFTER THE DILATOR WAS REMOVED, AN ADVISOR HD GRID CATHETER WAS INSERTED INTO THE AGILIS SHEATH. THE LEAKING AGILIS SHEATH VALVE WAS NOTICED UPON THE REMOVAL OF THE ADVISOR HD GRID CATHETER. THE AGILIS SHEATH WAS EXCHANGED, AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25184519 ↗
• MalfunctionMay 15, 2026Fluid/Blood Leak; Gas/Air Leak

  DURING AN ATRIAL FIBRILLATION PROCEDURE USING A NON-ABBOTT SYSTEM (FARAPULSE), BACKFLOW OF BLOOD WAS OBSERVED FROM THE SHEATH HEMOSTASIS VALVE WHEN A NON-ABBOTT CATHETER (PULSE CATHETER) WAS INSERTED INTO THE SHEATH. WHEN AIR ASPIRATION WAS PERFORMED VIA THE SIDE PORT USING A SYRINGE, AIR WAS ASPIRATED. THE SHEATH WAS REPLACED WITH A NON-ABBOTT SHEATH (FARA DRIVE), AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25184140 ↗
• MalfunctionMay 14, 2026Gas/Air Leak

  DURING THE SECOND VOLT PULSED FIELD ABLATION PROCEDURE IN THE LA, AIR WAS ASPIRATED FROM THE SHEATH AND ST ELEVATION WAS NOTED ON ECG AFTER THE VOLT CATHETER WAS INSERTED. THE AGILIS SHEATH WAS REPLACED AND THE VOLT CATHETER WAS INSERTED STRAIGHT WITH THE AGILIS HANDLE BELOW PATIENT LEVEL. AIR WAS ASPIRATED FROM THE SECOND SHEATH AS WELL. THERE WAS NO FURTHER ST ELEVATION. THE PHYSICIAN WAS ABLE TO TURN THE AGILIS ANGLE WITH THE IRRIGATION PORT 360 DEGREES WHILE ASPIRATING WITH A 2 ML SYRINGE TO REDUCE VACUUM PRESSURE. NO INTERVENTION WAS PERFORMED. THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25175365 ↗
• MalfunctionMay 14, 2026Gas/Air Leak

  DURING THE SECOND VOLT PULSED FIELD ABLATION PROCEDURE IN THE LA, AIR WAS ASPIRATED FROM THE SHEATH AND ST ELEVATION WAS NOTED ON ECG AFTER THE VOLT CATHETER WAS INSERTED. THE AGILIS SHEATH WAS REPLACED AND THE VOLT CATHETER WAS INSERTED STRAIGHT WITH THE AGILIS HANDLE BELOW PATIENT LEVEL. AIR WAS ASPIRATED FROM THE SECOND SHEATH AS WELL. THERE WAS NO FURTHER ST ELEVATION. THE PHYSICIAN WAS ABLE TO TURN THE AGILIS ANGLE WITH THE IRRIGATION PORT 360 DEGREES WHILE ASPIRATING WITH A 2 ML SYRINGE TO REDUCE VACUUM PRESSURE. NO INTERVENTION WAS PERFORMED. THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: Air Embolism; Arrhythmia

  MAUDE report 25175305 ↗
• MalfunctionMay 12, 2026Fluid/Blood Leak

  DURING THE ATRIAL FIBRILLATION PROCEDURE, PERSISTENT BLOOD LEAKAGE FROM THE SHEATH VALVE WAS OBSERVED DURING PRE-MAPPING. 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 25149769 ↗
• MalfunctionMay 7, 2026Fluid/Blood Leak; Gas/Air Leak

  DURING AN AF ABLATION PROCEDURE, PERSISTENT AIR INGRESS WAS OBSERVED INVOLVING THE AGILIS SHEATH AND VOLT CATHETER FOLLOWING SUCCESSFUL TRANSSEPTAL PUNCTURE AND MAPPING WITH AN ADVISOR HD GRID X CATHETER. UPON INITIAL ADVANCEMENT OF THE VOLT CATHETER, AIR WAS ASPIRATED BUT THERE WAS NO BLOOD RETURN. THE ADVISOR HD GRID X CATHETER WAS REINSERTED INTO THE SAME SHEATH AND BLOOD ASPIRATION WAS CONFIRMED. REINTRODUCTION OF THE VOLT CATHETER AGAIN RESULTED IN CONSISTENT AIR ASPIRATION. BOTH THE AGILIS SHEATH AND VOLT CATHETER WERE REPLACED; HOWEVER, AIR ASPIRATION PERSISTED. BLOOD WAS SUBSEQUENTLY OBSERVED LEAKING FROM THE AGILIS HEMOSTATIC VALVE. THE ABBOTT DEVICES WERE REPLACED, AND THE PROCEDURE WAS COMPLETED USING NON-ABBOTT DEVICES (FARADRIVE STEERABLE SHEATH AND FARAWAVE PFA CATHETER) WITH NO ADVERSE PATIENT OUTCOMES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25117028 ↗
• MalfunctionMay 7, 2026Gas/Air Leak

  DURING AN AF ABLATION PROCEDURE, PERSISTENT AIR INGRESS WAS OBSERVED INVOLVING THE AGILIS SHEATH AND VOLT CATHETER FOLLOWING SUCCESSFUL TRANSSEPTAL PUNCTURE AND MAPPING WITH AN ADVISOR HD GRID X CATHETER. UPON INITIAL ADVANCEMENT OF THE VOLT CATHETER, AIR WAS ASPIRATED BUT THERE WAS NO BLOOD RETURN. THE ADVISOR HD GRID X CATHETER WAS REINSERTED INTO THE SAME SHEATH AND BLOOD ASPIRATION WAS CONFIRMED. REINTRODUCTION OF THE VOLT CATHETER AGAIN RESULTED IN CONSISTENT AIR ASPIRATION. BOTH THE AGILIS SHEATH AND VOLT CATHETER WERE REPLACED; HOWEVER, AIR ASPIRATION PERSISTED. BLOOD WAS SUBSEQUENTLY OBSERVED LEAKING FROM THE AGILIS HEMOSTATIC VALVE. THE ABBOTT DEVICES WERE REPLACED, AND THE PROCEDURE WAS COMPLETED USING NON-ABBOTT DEVICES (FARADRIVE STEERABLE SHEATH AND FARAWAVE PFA CATHETER) WITH NO ADVERSE PATIENT OUTCOMES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25117025 ↗
• MalfunctionMay 7, 2026Difficult to Insert; Gas/Air Leak

  DURING THE AF PROCEDURE WITH VOLT, IT WAS NOTED THAT IT WAS DIFFICULT TO INTRODUCE THE VOLT CATHETER INTO THE AGILIS. ONLY AIR WAS PULLED OUT OF THE SYRINGE WHEN THE VOLT WAS INSERTED INTO THE AGILIS. IT WOULD NOT ASPIRATE AS EXPECTED. THE AGILIS WAS THE DEVICE THAT SEEMED TO HAVE AIR PULLING INTO IT. THE AGILIS WAS REPLACED, WHICH RESOLVED THE ISSUE, AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25115796 ↗
• MalfunctionMay 6, 2026Material Puncture/Hole

  THIS REPORT IS TO ADVISE OF A PUNCTURED DILATOR THAT WAS NOTED DURING ANALYSIS. DURING THE ATRIAL FIBRILLATION PROCEDURE, THE TIP OF THE DILATOR WAS BENT DURING THE PASSAGE OF THE BRK NEEDLE. THE PATIENT ANATOMY WAS UNUSUAL AND THE CURVATURE OF THE VEIN COMPLICATED ACCESS FOR THE TRANSSEPTAL PUNCTURE. THE SHEATH WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25107928 ↗
• MalfunctionMay 6, 2026Gas/Air Leak

  DURING A PFA PROCEDURE, AFTER INSERTING THE VOLT CATHETER INTO THE SHEATH AND ASPIRATING FIRST WITH A 20CC SYRINGE THEN WITH A 50CC SYRINGE, ONLY AIR WAS ASPIRATED. 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 25107819 ↗
• MalfunctionMay 6, 2026Material Puncture/Hole

  DURING A PFA/AF PROCEDURE, TRANSSEPTAL PUNCTURE WAS ATTEMPTED AND THE DILATOR WAS PUNCTURED. WHEN POSITIONING THE AGILIS AND DILATOR ON THE FO, THE DILATOR WAS BENT A LITTLE AND THE BRK PUNCTURED THE DILATOR. THE INTRODUCER WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25097993 ↗