Swartz™ 407453Recalls & reported problems

Summary

The FDA's MAUDE database contains 287 adverse event reports that list this exact device (DI 05414734205771), received between Jun 12, 2018 and Sep 29, 2026 — classified as 4 deaths, 24 injuries, 259 malfunctions.

The most frequently reported specific device problem is “Gas/Air Leak” (79 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 287 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Flaked

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50939098 ↗
• MalfunctionSep 24, 2026Gas/Air Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50887840 ↗
• MalfunctionSep 1, 2026Gas/Air Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50543705 ↗
• MalfunctionAug 13, 2026Gas/Air Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50241051 ↗
• MalfunctionJun 15, 2026Gas/Air Leak

  DURING THE LEFT SIDED ACCESSORY PATHWAY ABLATION PROCEDURE, AN AIR LEAK WAS NOTED WHEN ASPIRATING THE SHEATH. WHILE ASPIRATING THERE WAS INITIALLY BLOOD AND THEN CONTINUOUS AIR ASPIRATION. THE BRK NEEDLE WAS EXCHANGED WITH RESOLUTION OF THE ISSUE AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE PATIENT HEALTH CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25511898 ↗
• MalfunctionJun 10, 2026Flaked

  THIS REPORT IS TO ADVISE OF SKIVING FOUND IN THE SHEATH DURING ANALYSIS. DURING THE ATRIAL FIBRILLATION PROCEDURE, RESISTANCE WAS FELT WHEN INSERTING THE BRK NEEDLE INTO THE SWARTZ 8.5 FR SHEATH. THE NEEDLE WAS REMOVED AND THE SWARTZ 8.5 FR SHEATH WAS EXCHANGED. THE PROCEDURE WAS COMPLETED AND THERE WERE NO ADVERSE PATIENT HEALTH OUTCOMES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25458756 ↗
• MalfunctionJun 4, 2026Flaked

  THIS REPORT IS TO ADVISE OF SKIVING FOUND DURING ANALYSIS. DURING THE PVI PROCEDURE, THERE WERE INSERTION DIFFICULTIES WHEN INSERTING THE BRK INTO THE SHEATH. 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 25394010 ↗
• MalfunctionMay 4, 2026Material Separation; Gas/Air Leak

  DURING THE AF PROCEDURE, AFTER THE TRANSSEPTAL PUNCTURE, THE GUIDWIRE WAS ADVANCED THROUGH THE SHEATH. IT WAS THEN NOTED THAT THERE WAS A SIGNIFICANT NUMBER OF BUBBLES IN THE SALINE TUBE. IT WAS THEN NOTED THAT THE SALINE LINE HAD BECOME DISCONNECTED FROM THE JUNCTION. THE 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 25070681 ↗
• MalfunctionApr 22, 2026Gas/Air Leak

  DURING THE ATRIAL FIBRILLATION PROCEDURE, AIR LEAKED FROM THE SHEATH. AFTER CATHETER INSERTION, AIR ENTRY WAS OBSERVED DURING BLOOD BACKFLOW. 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 24957240 ↗
• MalfunctionApr 8, 2026Gas/Air Leak

  DURING THE PROCEDURE, AIR LEAKED FROM THE SHEATH. 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 24819265 ↗
• MalfunctionApr 8, 2026Fluid/Blood Leak; Gas/Air Leak

  THIS REPORT IS TO ADVISE OF AN AIR LEAK AND A FLUID LEAK THAT WERE NOTED DURING ANALYSIS. DURING THE AF PROCEDURE, WHILE ATTEMPTING TO IRRIGATE THE SHEATH AFTER SEPTAL PUNCTURE, BLOOD WAS NOT FLUSHING BACK THROUGH THE IRRIGATION PORT. 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 24817224 ↗
• MalfunctionApr 8, 2026Flaked

  DURING THE ATRIAL FIBRILLATION PROCEDURE, THE INNER DILATOR OF THE SHEATH WAS SCRATCHED BY THE TRANSSEPTAL NEEDLE, AND THE PLASTIC WAS STUCK ON THE NEEDLE WHEN IT WAS BEING ADVANCED. BOTH DEVICES WERE REPLACED AND THE ISSUE WAS RESOLVED AND THE PROCEDURE WAS COMPLETED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES BEFORE, DURING AND AFTER THE PROCEDURE. THE STYLET WAS NOT USED, AND THE NEEDLE WAS NOT RESHAPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24816266 ↗
• MalfunctionMar 31, 2026Fluid/Blood Leak

  DURING THE PROCEDURE, THE HEMOSTASIS VALVE LEAKED SALINE. THE SHEATH WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24743933 ↗
• MalfunctionMar 31, 2026Flaked

  THIS REPORT IS TO ADVISE OF SKIVING FOUND DURING INVESTIGATION. DURING THE DURING THE LEFT SIDED ATYPICAL FLUTTER PROCEDURE, WHEN ATTEMPTING TRANSSEPTAL PUNCTURE IN THE LEFT ATRIUM, IT WAS NOTED THAT THE NEEDLE COULD NOT BE INSERTED INTO THE SHEATH. THE 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 24740109 ↗
• MalfunctionMar 25, 2026Fluid/Blood Leak

  DURING THE ATRIAL FIBRILLATION PROCEDURE WITH CARTO, FLUID BACKFLOW WAS OBSERVED FROM THE HEMOSTATIC VALVE OF THE SWARTZ SHEATH FOLLOWING THE REMOVAL OF THE GUIDEWIRE AND DILATOR. THE SWARTZ 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 24689434 ↗
• MalfunctionMar 20, 2026Fluid/Blood Leak

  DURING THE ATRIAL FIBRILLATION PROCEDURE, BLOOD LEAKED FROM THE HEMOSTASIS VALVE OF THE SHEATH. AFTER THE SHEATH WAS INSERTED INTO THE LEFT ATRIUM, THE MAPPING CATHETER WAS ADVANCED THROUGH THE SHEATH, AND BLOOD LEAKAGE WAS OBSERVED FROM THE HEMOSTATIC VALVE. 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 24649246 ↗
• MalfunctionMar 4, 2026Gas/Air Leak

  DURING THE ATRIAL FIBRILLATION PROCEDURE, AIR WAS ASPIRATED FROM THE HEMOSTASIS VALVE. THE INTRODUCER WAS REPLACED, BUT THE SAME ISSUE OCCURRED. THE INTRODUCER WAS REPLACED AGAIN, AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24512988 ↗
• MalfunctionMar 4, 2026Gas/Air Leak

  DURING THE ATRIAL FIBRILLATION PROCEDURE, AIR WAS ASPIRATED FROM THE HEMOSTASIS VALVE. THE INTRODUCER WAS REPLACED, BUT THE SAME ISSUE OCCURRED. THE INTRODUCER WAS REPLACED AGAIN, AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24507451 ↗
• MalfunctionFeb 27, 2026Gas/Air Leak

  DURING THE ATRIAL FIBRILLATION PROCEDURE, AIR LEAKED THROUGH THE VALVE OF THE SHEATH. WHILE ATTEMPTING TO ASPIRATE AIR AFTER THE FEMORAL PUNCTURE, AIR WAS INTRODUCED THROUGH THE VALVE OF THE SHEATH. 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 24473299 ↗
• MalfunctionFeb 27, 2026Material Separation

  DURING AN ATRIAL FIBRILLATION PROCEDURE, THE SIDEPORT DETACHED. THE INTRODUCER WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24470265 ↗
• MalfunctionFeb 6, 2026Gas/Air Leak

  DURING A PROCEDURE, AIR WAS ASPIRATED WHEN THE DILATOR WAS REMOVED. 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 24282145 ↗
• MalfunctionFeb 3, 2026Flaked

  DURING THE VENTRICULAR TACHYCARDIA PROCEDURE, SKIVING WAS NOTED AFTER INSERTION INTO THE PATIENT. SMALL PLASTIC PARTICLES OF THE INTRODUCER WERE NOTED AT THE TIP OF THE BRK NEEDLE WHEN IT WAS REMOVED. THE NEEDLE WAS NOT RESHAPED AND THE STYLET WAS USED. THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24253747 ↗
• MalfunctionJan 26, 2026Gas/Air Leak

  DURING THE ATRIAL FIBRILLATION PROCEDURE, AIR LEAKED FROM THE SHEATH. 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 24176854 ↗
• MalfunctionJan 6, 2026Fluid/Blood Leak

  DURING AN AF PROCEDURE, AFTER THE INTRODUCER WAS INSERTED INTO THE BODY, BLOOD LEAKAGE WAS NOTED. THE INTRODUCER WAS REPLACED, AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT. THE HOSPITAL DISCARDED THE REPORTED INTRODUCER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23975281 ↗
• MalfunctionJan 3, 2026Flaked; Improper or Incorrect Procedure or Method

  THIS REPORT IS TO ADVISE OF SKIVING THAT WAS NOTED DURING ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23952943 ↗