Swartz™ 407449Recalls & reported problems

Summary

The FDA's MAUDE database contains 130 adverse event reports that list this exact device (DI 05414734205733), received between Jul 18, 2018 and Apr 29, 2026 — classified as 3 deaths, 24 injuries, 103 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (50 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 130 reports, in the reporter's own words as published by the FDA.

• InjuryApr 29, 2026Adverse Event Without Identified Device or Use Problem

  DURING A VOLT PFA ABLATION (AF) PROCEDURE, EXTRAVASATION WAS DIAGNOSED REQUIRING A BALLOON TO REPAIR. A WIRE WAS ADVANCED INTO THE RIGHT ATRIUM. ACCORDING TO THE PHYSICIAN, THIS WENT VERY EASILY AND WITHOUT PROBLEMS. AN ATTEMPT WAS THEN MADE TO ADVANCE THE 13F AGILIS SHEATH INTO THE RIGHT ATRIUM AS WELL. THIS FAILED DUE TO RESISTANCE. THE PHYSICIAN THEN TRIED AGAIN WITH AN SL0 SHEATH, WHICH ALSO DID NOT WORK. THE PATIENT WAS OF ADVANCED AGE AND ACCORDINGLY HAD VENOUS KINKING. CONTRAST MEDIUM WAS THEN INJECTED INTO THE VEIN, AND EXTRAVASATION WAS DETECTED IN THE LOWER REGION AT THE LEVEL OF THE PELVIS. THIS WAS SEALED WITH A BALLOON. THE VESSEL THEN APPEARED NORMAL ON THE X-RAYS AFTER. THE PHYSICIAN COULD NOT DETERMINE EXACTLY WHETHER THE AGILIS, OR THE SL0 HAD CAUSED THE PROBLEM. THE PROCEDURE WAS SUBSEQUENTLY ABORTED DUE TO THE EXTRAVASATION. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICE.

  Patient problems: Unspecified Vascular Problem

  MAUDE report 25034163 ↗
• MalfunctionMar 24, 2026Material Puncture/Hole

  DURING AN ATRIAL FIBRILLATION PROCEDURE, THE TRANSSEPTAL NEEDLE PUNCTURED THE SHEATH. THE SHEATH WAS EXCHANGED AND THE PROCEDURE WAS COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24678267 ↗
• MalfunctionMar 17, 2026Fluid/Blood Leak

  DURING AN ATRIAL FIBRILLATION PROCEDURE, A FLUID LEAK WAS OBSERVED FROM THE SHEATH. THE SHEATH WAS EXCHANGED, BUT THE SAME ISSUE OCCURRED WITH THE SECOND SHEATH. THE SHEATH WAS EXCHANGED AGAIN AND THE ISSUE WAS RESOLVED. THE PROCEDURE WAS COMPLETED WITH NO ADVERSE PATIENT HEALTH CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24617789 ↗
• MalfunctionMar 17, 2026Fluid/Blood Leak

  DURING AN ATRIAL FIBRILLATION PROCEDURE, A FLUID LEAK WAS OBSERVED FROM THE SHEATH. THE SHEATH WAS EXCHANGED, BUT THE SAME ISSUE OCCURRED WITH THE SECOND SHEATH. THE SHEATH WAS EXCHANGED AGAIN AND THE ISSUE WAS RESOLVED. THE PROCEDURE WAS COMPLETED WITH NO ADVERSE PATIENT HEALTH CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24617783 ↗
• MalfunctionMar 4, 2026Material Puncture/Hole

  DURING THE PROCEDURE, WITH THE SHEATH POSITIONED NEAR THE SUPERIOR VENA CAVA, THE BRK NEEDLE WAS ADVANCED INTO THE SHEATH FOR THE TRANSSEPTAL PUNCTURE. THE NEEDLE PERFORATED THE SHEATH JUST BEFORE ITS CURVE, AS SEEN UNDER FLUOROSCOPY. THE NEEDLE DOES NOT APPEAR TO HAVE INJURED THE VEIN. AS A PRECAUTION, THE PHYSICIAN DECIDED TO STOP THE PROCEDURE. IMAGING AND INCREASED MONITORING WERE PERFORMED. NO PERICARDIAL EFFUSION WAS OBSERVED, AND HEMODYNAMIC PARAMETERS REMAINED STABLE THROUGHOUT. THERE WERE NO CONSEQUENCES FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24510175 ↗
• MalfunctionFeb 23, 2026Gas/Air Leak

  DURING AN ATRIAL FIBRILLATION PROCEDURE, AIR ASPIRATED FROM THE SHEATH AFTER INSERTING THE SHEATH INTO THE PATIENT. 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 24419836 ↗
• MalfunctionFeb 9, 2026Flaked

  THIS REPORT IS TO ADVISE OF SKIVING NOTED DURING INVESTIGATION. DURING THE ATRIAL FIBRILLATION PROCEDURE, IT WAS NOTED THAT THE NEEDLE COULD NOT BE ADVANCED THROUGH 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 24291088 ↗
• MalfunctionJan 23, 2026Gas/Air Leak

  DURING THE ATRIAL FIBRILLATION PROCEDURE, AFTER INSERTION, AIR REMOVAL WAS ATTEMPTED USING A SYRINGE; HOWEVER, AIR CONTINUED TO BE ASPIRATED. 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 24160782 ↗
• MalfunctionDec 30, 2025Gas/Air Leak; Gas/Air Leak

  DURING A PVI PROCEDURE, AN AIR LEAK WAS OBSERVED. THE SWARTZ SL0 SHEATH CONTINUOUSLY DREW IN AIR DURING ASPIRATION AFTER INSERTION IN THE PATIENT. THE SITUATION DID NOT IMPROVE, EVEN AFTER REPEATED ASPIRATION. TO RESOLVE, THE SHEATH WAS EXCHANGED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23921598 ↗
• MalfunctionDec 30, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS NOTED DURING A PVI PROCEDURE THAT THE SWARTZ SL0 SHEATH CONTINUOUSLY DREW IN AIR DURING ASPIRATION AFTER INSERTION IN THE PATIENT. THE SITUATION DID NOT IMPROVE AFTER REPEATED ASPIRATION. TO RESOLVE, THE SHEATH WAS EXCHANGED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23921497 ↗
• MalfunctionDec 16, 2025Gas/Air Leak; Gas/Air Leak

  DURING AN ATRIAL FIBRILLATION PROCEDURE, AN AIR LEAK OCCURRED. THE SHEATH WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23822010 ↗
• MalfunctionDec 12, 2025Fluid/Blood Leak; Fluid/Blood Leak

  DURING AN ATRIAL FIBRILLATION PROCEDURE, THE HEMOSTATIC VALVE OF THE SHEATH LEAKED BLOOD UPON INSERTION INTO THE PATIENT. THE SHEATH WAS EXCHANGED, AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE PATIENT HEALTH CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23786626 ↗
• MalfunctionDec 10, 2025Gas/Air Leak; Gas/Air Leak

  DURING THE ATRIAL FIBRILLATION PROCEDURE, THE HEMOSTASIS VALVE LEAKED AIR. THE SHEATH WAS PREPARED AS USUAL, BUT WHEN IT WAS INSERTED TO PERFORM THE TRANSSEPTAL PUNCTURE, THE HEMOSTASIS VALVE LEAKED. THE NEEDLE WAS NOT INSERTED 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 23767502 ↗
• MalfunctionDec 9, 2025Gas/Air Leak; Gas/Air Leak

  DURING AN ATRIAL FIBRILLATION PROCEDURE, AIR ASPIRATED FROM THE SHEATH. AIR WAS ASPIRATED EVEN WHEN PULLING THE PULLING THE SYRINGE SEVERAL TIMES. 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 23764344 ↗
• MalfunctionDec 2, 2025Gas/Air Leak; Gas/Air Leak

  DURING THE PAROXYSMAL ATRIAL FIBRILLATION PROCEDURE, AIR WAS ASPIRATED WHEN USING A SYRINGE TO REMOVE AIR AFTER 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 23694662 ↗
• MalfunctionNov 3, 2025Fluid/Blood Leak; Fluid/Blood Leak

  DURING AN ATRIAL FIBRILLATION PROCEDURE, BEFORE TRANSSEPTAL PUNCTURE BLOOD CAME OUT OF THE DILATOR OF THE SHEATH. THE SHEATH WAS EXCHANGED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ADVERSE HEALTH CONSEQUENCES FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23460145 ↗
• MalfunctionAug 6, 2025Fluid/Blood Leak; Fluid/Blood Leak

  DURING AN ATRIAL TACHYCARDIA PROCEDURE, A BLOOD LEAK OCCURRED FROM THE HEMOSTASIS VALVE. IMMEDIATELY AFTER THE SHEATH WAS INSERTED INTO THE RIGHT ATRIUM AND BEFORE THE SEPTAL PUNCTURE OR CATHETER INSERTION, THE DILATOR WAS REMOVED AND A BLOOD LEAK WAS NOTED FROM THE HEMOSTASIS 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 22729049 ↗
• MalfunctionAug 4, 2025Fluid/Blood Leak; Fluid/Blood Leak

  DURING A PULMONARY VEIN ISOLATION PROCEDURE, BLOOD LEAKED FROM THE HEMOSTASIS VALVE. 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 22704673 ↗
• MalfunctionJul 17, 2025Fluid/Blood Leak; Fluid/Blood Leak

  DURING AN ATRIAL FIBRILLATION PROCEDURE, A BLOOD LEAK WAS NOTED FROM THE HEMOSTASIS VALVE. THE SHEATH WAS INSERTED INTO THE RIGHT ATRIUM, AND BLOOD LEAKED FROM THE HEMOSTASIS VALVE BEFORE CATHETER INSERTION AND TRANSEPTAL PUNCTURE. 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 22530557 ↗
• MalfunctionMay 5, 2025Gas/Air Leak; Gas/Air Leak

  DURING AN ATRIAL FIBRILLATION PROCEDURE, AN AIR LEAK WAS NOTED FROM THE HEMOSTASIS VALVE. WHEN ATTEMPTING TO ASPIRATE TO CONNECT TO FLUSH THE SALINE PERFUSION, BUBBLES ENTERED THE SYRINGE. THE SHEATH WAS EXCHANGED, AND THE PROCEDURE WAS COMPLETED WITH NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21961181 ↗
• MalfunctionMay 5, 2025Gas/Air Leak; Gas/Air Leak

  DURING AN ATRIAL FLUTTER PROCEDURE, THE SL0 LOCK DRAWS AIR WHEN THE WIRE IS STILL IN LOCK. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE WITH NO CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21960731 ↗
• MalfunctionApr 29, 2025Gas/Air Leak; Gas/Air Leak

  DURING THE ATRIAL FIBRILLATION PROCEDURE, AN AIR LEAK OCCURRED. AFTER PREPARING AND FLUSHING THE INTRODUCER, IT WAS INSERTED INTO THE RIGHT ATRIUM. WITH THE INTRODUCER LEANED AGAINST THE SEPTAL WALL, AIR WAS OBSERVED IN THE TRANSPARENT PART, ENTERING THROUGH THE HEMOSTASIS VALVE. 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 21925310 ↗
• MalfunctionApr 21, 2025Fluid/Blood Leak; Fluid/Blood Leak

  DURING THE ATRIAL FIBRILLATION PROCEDURE, THE SHEATH AND DILATOR WERE INTEGRATED AND INSERTED INTO THE RIGHT ATRIUM. BEFORE SEPTAL PUNCTURE, BLOOD LEAKED FROM THE HEMOSTATIC VALVE. THE SHEATH WAS REPLACED, AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT. NO AIR MOVEMENT INTO THE PATIENT WAS CONFIRMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21875358 ↗
• MalfunctionMar 28, 2025Gas/Air Leak; Gas/Air Leak

  DURING A PULMONARY VEIN ISOLATION PROCEDURE FOR ATRIAL FIBRILLATION USING CARTO, AIR WAS ASPIRATED WHILE FLUSHING. 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 21718910 ↗
• MalfunctionFeb 21, 2025Gas/Air Leak; Gas/Air Leak

  DURING PROCEDURE RIGHT AFTER THE CATHETER WAS INSERTED INTO THE SHEATH, AIR WAS ASPIRATED FROM HEMOSTASIS VALVE. BEFORE INSERTING THE TRANSSEPTAL NEEDLE, THE DILATOR WAS INSERTED INTO THE SHEATH INTRODUCER. THE TRANSSEPTAL NEEDLE WAS FROM BAYLIS STANDARD CURVE 71CM . THE MODEL AND LOT NUMBER ARE UNKNOWN. THE DEVICES INSERTED DIRECTLY INTO THE HEMOSTATIC VALVE UNTIL THE REPORTED EVENT OCCURRED WERE DILATOR, GUIDEWIRE, TRANSSEPTAL NEEDLE, AND CATHETER. NO RESISTANCE WAS NOTED WITH THE FIRST DEVICE INSERTED INTO THE SHEATH¿S HEMOSTATIC VALVE. THERE WAS NO MOVEMENT OF AIR INTO THE PATIENT¿S BODY, ALSO NO ABNORMAL FINDINGS ON THE ELECTROCARDIOGRAM. NO ADDITIONAL PUNCTURE AT THE ACCESS SITE WAS NECESSARY DURING SHEATH REPLACEMENT. THE INTRODUCER WAS REPLACED, AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE PATIENT HEALTH CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21434898 ↗