Swartz™ 407439Recalls & reported problems

Summary

The FDA's MAUDE database contains 115 adverse event reports that list this exact device (DI 05414734205634), received between Aug 6, 2018 and Sep 22, 2026 — classified as 5 deaths, 11 injuries, 99 malfunctions.

The most frequently reported specific device problem is “Material Puncture/Hole” (45 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 115 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 22, 2026Difficult to Insert; Material Puncture/Hole

  During the atrial fibrillation procedure, it was noted that the Swartz sheath was punctured by the BRK needle during transseptal. While initiating transseptal puncture with the BRK needle it was noted that there was resistance in the sheath. The entire assembly was withdrawn from the patient, and it was noted that the BRK needle had punctured the Swartz sheath. The Swartz sheath was exchanged, and transseptal puncture was completed successfully. The procedure was completed with no adverse patient health consequences.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50860186 ↗
• MalfunctionJun 17, 2026Flaked

  THIS REPORT IS TO ADVISE OF SKIVING FOUND IN THE SHEATH DURING ANALYSIS. DURING THE ATRIAL FIBRILLATION PROCEDURE, WHEN THE TRANSSEPTAL PUNCTURE WAS ATTEMPTED, THE NEEDLE COULD NOT BE INTRODUCED THROUGH THE SHEATH. THE SHEATH WAS OBSTRUCTED. 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 25536095 ↗
• MalfunctionApr 28, 2026Material Puncture/Hole

  DURING AN ATRIAL FIBRILLATION PROCEDURE, DURING INSERTION INTO THE PATIENT, THE NEEDLE PUNCTURED THE SHEATH. THE SHEATH WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25024102 ↗
• MalfunctionMar 11, 2026Gas/Air Leak

  DURING AN AF PROCEDURE, AIR WAS ASPIRATED FROM THE VALVE. THE SHEATH WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24575412 ↗
• MalfunctionJan 20, 2026Fluid/Blood Leak

  DURING AN AF PROCEDURE, BLOOD LEAKAGE WAS OBSERVED. 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 24118801 ↗
• MalfunctionNov 17, 2025Material Puncture/Hole; Material Puncture/Hole

  THIS REPORT IS TO ADVISE OF A PUNCTURED SHEATH AND DILATOR THAT WAS NOTED DURING ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23577229 ↗
• MalfunctionNov 11, 2025Gas/Air Leak; Gas/Air Leak

  DURING THE ATRIAL FIBRILLATION PROCEDURE, AIR WAS ASPIRATED FROM THE SHEATH AFTER INSERTION. 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 23526658 ↗
• MalfunctionSep 19, 2025Gas/Air Leak; Gas/Air Leak

  DURING AN ATYPICAL LEFT ATRIAL FLUTTER PROCEDURE, AN AIR LEAK OCCURRED. AFTER MAPPING THE LEFT ATRIUM, THE PHYSICIAN ATTEMPTED TO EXCHANGE THE CATHETER FOR A TACTICATH SE TO BEGIN ABLATION. AIR ENTERED THE SHEATH DURING HD GRID WITHDRAWAL BUT WAS IMMEDIATELY ASPIRATED. SHORTLY AFTER, THE PATIENT DEVELOPED BRADYCARDIA AND ST ELEVATION (DISPLAYED ON ALL ECG LEADS), LIKELY DUE TO AIR ENTERING THE BLOODSTREAM. SEDATION WAS PAUSED TO ASSESS FOR NEUROLOGICAL SYMPTOMS DUE TO CEREBRAL AIR INGRESS, BUT NONE WERE FOUND. ST ELEVATION RESOLVED WITHIN MINUTES, AND ABLATION RESUMED USING THE TACTICATH AFTER EXCHANGING THE SL1 SHEATH FOR AN AGILIS. THE PROCEDURE WAS THEN SUCCESSFULLY COMPLETED.

  Patient problems: Air Embolism; Arrhythmia

  MAUDE report 23097734 ↗
• MalfunctionSep 15, 2025Material Puncture/Hole; Material Puncture/Hole

  DURING THE TRANSSEPTAL PUNCTURE, THE BRK1 NEEDLE PERFORATED THE SWARTZ SHEATH. THE STYLET WAS USED DURING THE TRANSSEPTAL PUNCTURE PROCEDURE. THE SHEATH WAS REPLACED, AND THE PROCEDURE CONTINUED WITHOUT ANY ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23048211 ↗
• MalfunctionAug 8, 2025Material Puncture/Hole; Material Puncture/Hole

  DURING THE PROCEDURE, WHEN PREPARING THE DEVICE FOR TRANSSEPTAL PUNCTURE, THE NEEDLE PUNCTURED SHEATH. ANOTHER SHEATH WAS USED TO COMPLETE THE PROCEDURE WITH NO CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22748437 ↗
• MalfunctionAug 6, 2025Material Puncture/Hole; Material Puncture/Hole

  DURING A PULMONARY VEIN ISOLATION PROCEDURE, A SHEATH PUNCTURE OCCURRED. THE SHEATH WAS PLACED INTO THE RIGHT ATRIUM FOR TRANSSEPTAL PUNCTURE. THE STYLET OF THE BRK NEEDLE WAS ADVANCED THROUGH THE DILATOR WITH SOME RESISTANCE NOTED. A FEW ATTEMPTS WERE DONE UNSUCCESSFULLY, AND THE STYLET WOULD NOT ADVANCE THROUGH THE DILATOR. FRICTION WAS NOTED ON THE OUTSIDE OF THE DILATOR AND WHEN FLUSHED AND A HOLE WAS NOTED IN THE DILATOR. THE SHEATH WAS EXCHANGED AND THE PROCEDURE CONTINUED WITH NO CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22728310 ↗
• MalfunctionJun 27, 2025Flaked; Improper or Incorrect Procedure or Method; Flaked; Improper or Incorrect Procedure or Method

  DURING TRANSSEPTAL PUNCTURE FOR A VENTRICULAR TACHYCARDIA PROCEDURE, WHEN REMOVING THE NEEDLE FROM THE SHEATH, A FRAGMENT OF THE SHEATH WAS NOTED. IT WAS SUGGESTED TO EXCHANGE THE SHEATH; HOWEVER, THE PROCEDURE WAS COMPLETED WITH NO ADVERSE PATIENT CONSEQUENCES WITH THE SAME SHEATH. A STYLET WAS NOT USED, WHICH DOES NOT FOLLOWING THE SWARTZ INTRODUCER INSTRUCTIONS FOR USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22343167 ↗
• InjuryJun 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING WAS PUBLISHED IN THE JOURNAL OF ARRHYTHMIA IN AN ARTICLE TITLED, "CLINICAL INSIGHTS INTO THE ROLE OF BEPRIDIL IN RECURRENCE PREVENTION AFTER ABLATION OF PERSISTENT ATRIAL FIBRILLATION"; MOYURU HIRATA MD1, 2025;41:E70083, HTTPS://DOI.ORG/10.1002/JOA3.70083 THIS RETROSPECTIVE STUDY INCLUDED 232 CONSECUTIVE PERAF PATIENTS WHO UNDERWENT AF ABLATION BETWEEN 2014 AND 2019. AMONG THEM, 162 RECEIVED BEPRIDIL FOR 3 MONTHS POST-ABLATION (BEPRIDIL GROUP), WHILE 70 RECEIVED NO ANTIARRHYTHMIC DRUGS (NO-AADS GROUP). BASELINE CHARACTERISTICS, PROCEDURAL DETAILS, AND OUTCOMES WERE COMPARED. KAPLAN¿MEIER ANALYSIS AND COX REGRESSION MODELS WERE USED TO EVALUATE AF/ATRIAL TACHYCARDIA (AT) RECURRENCE, WITH BEPRIDIL USE TREATED AS A TIME-DEPENDENT COVARIABLE. THERE WAS 1 EVENT OF PSEUDOANEURYSM.

  Patient problems: Pseudoaneurysm

  MAUDE report 22216675 ↗
• MalfunctionJun 2, 2025Flaked; Flaked

  THIS REPORT IS TO ADVISE OF SKIVING FOUND DURING ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22122545 ↗
• MalfunctionApr 29, 2025Fluid/Blood Leak; Fluid/Blood Leak

  DURING THE PULMONARY VEIN ISOLATION PROCEDURE, BLOOD LEAKED FROM THE GAP IN 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 21928696 ↗
• InjuryApr 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING AN ATRIAL FIBRILLATION PROCEDURE, A CARDIAC TAMPONADE OCCURRED DURING TRANSSEPTAL PUNCTURE WITH THE SWARTZ SHEATH. A PERICARDIOCENTESIS WAS PERFORMED WITH IMPROVEMENT IN BLOOD PRESSURE LEVELS.

  Patient problems: Cardiac Perforation

  MAUDE report 21865653 ↗
• MalfunctionDec 11, 2024Gas/Air Leak; Gas/Air Leak

  DURING THE ATRIAL FIBRILLATION PROCEDURE, AN AIR LEAK OCCURRED. THE SHEATH WAS INSERTED INTO THE HEART, THE SEPTAL PUNCTURE WAS PERFORMED, AND THE DILATOR WAS REMOVED. WHEN ASPIRATION WAS PERFORMED TO FLUSH, AIR WAS ASPIRATED. ASPIRATION WAS PERFORMED SEVERAL TIMES, BUT AIR COULD NOT BE COMPLETELY REMOVED. THE SHEATH WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT. NO AIR MOVEMENT INTO THE PATIENT WAS IDENTIFIED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20902525 ↗
• MalfunctionOct 21, 2024Material Puncture/Hole; Material Puncture/Hole

  DURING AN ATRIAL FIBRILLATION PROCEDURE WHEN THE NEEDLE WAS INSERTED IN THE SHEATH IN THE PATIENT, THE SHEATH WAS PUNCTURED BY THE NEEDLE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20500715 ↗
• DeathSep 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURING REFERENCE: 3008452825-2024-00502. DURING A VENTRICULAR TACHYCARDIA PROCEDURE, A CARDIAC TAMPONADE OCCURRED AND THE PATIENT EXPIRED. WHILE PERFORMING THE TRANSSEPTAL APPROACH, THE PATIENT'S BLOOD PRESSURE DROPPED FROM 110 TO 40. AN ECHOCARDIOGRAM WAS DONE WHICH IDENTIFIED A CARDIAC TAMPONADE. A PERICARDIOCENTESIS AND TRANSFUSION WERE PERFORMED, A TOTAL OF 1.5L WAS DRAINED. DURING THE PERICARDIOCENTESIS, THE PATIENT WENT INTO CARDIAC ARREST. CARDIAC MASSAGE WAS DONE BUT WAS UNSUCCESSFUL AND THE PATIENT DECEASED. THE PHYSICIAN BELIEVED THAT THE AORTA WAS PERFORATED BY THE SHEATH AND DILATOR DURING THE TRANSSEPTAL APPROACH.

  Patient problems: Cardiac Perforation; Great Vessel Perforation

  MAUDE report 20136858 ↗
• MalfunctionJul 18, 2024Material Puncture/Hole; Material Puncture/Hole

  DURING THE PROCEDURE, WHILE PERFORMING THE TRANSSEPTAL PUNCTURE, THE NEEDLE PENETRATED THE DILATOR AND ALSO THE SHEATH IN THE AREA OF THE CURVATURE SEVERAL TIMES. THE NEEDLE WOULD COME OUT EITHER DISTALLY BETWEEN THE SHEATH AND DILATOR OR LATERALLY IN THE AREA OF THE CURVATURE OF THE SHEATH. THE NEEDLE AND THE SHEATH WERE BOTH REPLACED WITH NON-ABBOTT DEVICES AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19780045 ↗
• MalfunctionJul 18, 2024Material Puncture/Hole; Material Puncture/Hole

  DURING THE PROCEDURE, WHILE PERFORMING THE TRANSSEPTAL PUNCTURE, THE NEEDLE PENETRATED THE DILATOR AND ALSO THE SHEATH IN THE AREA OF THE CURVATURE SEVERAL TIMES. THE NEEDLE WOULD COME OUT EITHER DISTALLY BETWEEN THE SHEATH AND DILATOR OR LATERALLY IN THE AREA OF THE CURVATURE OF THE SHEATH. THE NEEDLE AND THE SHEATH WERE BOTH REPLACED WITH NON-ABBOTT DEVICES AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT. THE NEEDLE WAS NOT RESHAPED AND THE STYLET WAS USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19780034 ↗
• MalfunctionJul 15, 2024Material Puncture/Hole; Material Puncture/Hole

  RELATED MANUFACTURE REF: (B)(4). DURING TRANSSEPTAL PUNCTURE, THE NEEDLE PUNCTURED THE DILATOR AND SHEATH IN THE AREA OF THE CURVATURE. THE NEEDLE COMES OUT EITHER DISTALLY BETWEEN THE SHEATH AND DILATOR OR LATERALLY IN THE AREA OF THE CURVATURE OF THE SHEATH. BOTH THE BRK NEEDLE AND THE SL SHEATH WERE EXCHANGED WHICH DID NOT RESOLVE THE ISSUE. A FASTCATH SHEATH WAS THEN USED TO COMPLETE THE PROCEDURE WITH NO CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19745027 ↗
• MalfunctionJul 1, 2024Material Puncture/Hole; Material Puncture/Hole

  DURING A CRYOABLATION, TRANSSEPTAL PUNCTURE WAS PERFORMED WITH A BRK NEEDLE THROUGH A SWARTZ SL1 SHEATH, AND A SLIGHT RESISTANCE WAS FELT. A VISUAL INSPECTION OF THE SHEATH REVEALED A PERFORATION WAS MADE. A NEW BRK NEEDLE AND SWARTZ SL1 SHEATH WAS THEN USED. THE SAME RESISTANCE WAS EXPERIENCED AND WHEN THE BRK NEEDLE WAS REMOVED, IT WAS FOUND THAT THE SHEATH WAS ONCE AGAIN PERFORATED. THE TRANSSEPTAL PUNCTURE WAS SUCCESSFULLY PERFORMED ON THE THIRD ATTEMPT WITH ANOTHER REPLACEMENT OF THE BRK NEEDLE AND SWARTZ SL0 SHEATH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19644694 ↗
• MalfunctionJun 10, 2024Gas/Air Leak; Gas/Air Leak

  DURING AN ATRIAL FIBRILLATION PROCEDURE, WHEN PULMONARY VEIN ISOLATION WAS PERFORMED WITH AN INTRODUCER, THE DEVICE VALVES WERE DAMAGED, AND AIR COULD NOT BE DISCHARGED EVEN IF AIR WAS ASPIRATED. THE INTRODUCER WAS REPLACED, AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT. THE HOSPITAL DISCARDED THE REPORTED DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19507032 ↗
• MalfunctionJun 7, 2024Material Puncture/Hole; Material Puncture/Hole

  THIS REPORT IS TO ADVISE OF A PUNCTURE FOUND IN THE SHEATH DURING ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19492173 ↗