Agilis NxT Steerable Introducer Dual-ReachRecalls & reported problems across all models

We found 3 models of Agilis NxT Steerable Introducer Dual-Reach by St. Jude Medical, Inc. in the FDA's device registry (GUDID). Together they are named in 457 adverse event reports in the FDA's MAUDE database, received between Mar 6, 2025 and Sep 30, 2026 — classified as 1 death, 44 injuries, 412 malfunctions.

The most frequently reported specific device problem is “Gas/Air Leak” (282 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

Most reported Agilis NxT Steerable Introducer Dual-Reach problems

Agilis NxT Steerable Introducer Dual-Reach models

3 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Agilis™ NxT Steerable Introducer Dual-Reach™ SI-1371-M

  Introducer, catheter
  1 death301 reports
• Agilis™ NxT Steerable Introducer Dual-Reach™ SI-1371-S

  Introducer, catheter
  151 reports
• Agilis™ NxT Steerable Introducer Dual-Reach™ SI-1371-L

  Introducer, catheter
  5 reports

Recent Agilis NxT Steerable Introducer Dual-Reach adverse event reports

The 15 most recent reports across all models, 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 30, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50952427 ↗
• 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

  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 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 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 ↗
• 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 ↗
• MalfunctionAug 4, 2026Activation, Positioning or Separation Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50132551 ↗
• 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 ↗

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