Swartz™ 407360Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 05414734205559), received between Apr 12, 2019 and Jul 10, 2025 — classified as 3 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Gas/Air Leak” (7 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 10, 2025Flaked; Flaked

  THIS REPORT IS TO ADVISE OF SKIVING NOTED DURING ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22469158 ↗
• MalfunctionNov 26, 2024Gas/Air Leak; Gas/Air Leak

  DURING A PROCEDURE, THE SHEATH WAS LEAKING AIR FROM THE SEALING LIP. AIR BUBBLES ENTERED THE SYSTEM. THE SHEATH WAS EXCHANGED, AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20789919 ↗
• MalfunctionNov 1, 2024Gas/Air Leak; Gas/Air Leak

  DURING A PROCEDURE, THE SEALING LIP OF THE SHEATH WAS LEAKING, AND AIR BUBBLE ENTERED THE SYSTEM. THE SHEATH WAS REPLACED, AND THE PROCEDURE WAS COMPLETED WITH THE PATIENT REMAINING STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20588673 ↗
• MalfunctionJul 10, 2024Gas/Air Leak; Gas/Air Leak

  DURING AN EXAMINATION, THE SHEATH AT THE SEALING LIP WAS LEAKING AIR AFTER INSERTION IN THE PATIENT. THE SHEATH WAS IMMEDIATELY REPLACED, AND THE INVESTIGATION CONTINUED. THE PATIENT IS STABLE. THE TRANSSEPTAL NEEDLE HAD BEEN INSERTED IN THE SHEATH PRIOR TO THE LEAK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19707801 ↗
• MalfunctionJul 6, 2024Fluid/Blood Leak; Fluid/Blood Leak

  DURING THE PROCEDURE, A BLOOD LEAK WAS OBSERVED FROM THE VALVE. THE SHEATH WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19685296 ↗
• MalfunctionJul 1, 2024Gas/Air Leak; Gas/Air Leak

  DURING THE PROCEDURE, IT WAS NOTED THAT THE SEALING LIP OF THE SHEATH WAS LEAKING AIR. THE SHEATH WAS REPLACED, AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE PATIENT CONSEQUENCES. THE BRK NEEDLE HAD BEEN INSERTED INTO THE SHEATH PRIOR TO THE LEAK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19645149 ↗
• MalfunctionFeb 22, 2024Gas/Air Leak; Gas/Air Leak

  DURING THE PROCEDURE, AN AIR LEAK OCCURRED. THE SHEATH WAS REPLACED AND THE PROCEDURE CONTINUED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18760831 ↗
• MalfunctionFeb 22, 2024Gas/Air Leak; Gas/Air Leak

  DURING THE PROCEDURE, AN AIR LEAK OCCURRED. THE SHEATH WAS REPLACED AND THE PROCEDURE CONTINUED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18760271 ↗
• MalfunctionFeb 20, 2023Fluid/Blood Leak; Gas/Air Leak; Fluid/Blood Leak; Gas/Air Leak

  DURING RIGHT ATRIAL ACCESS THE INTRODUCER WAS LEAKING AIR BEFORE INSERTION OF THE NEEDLE. THE INTRODUCER WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITH NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16405957 ↗
• MalfunctionOct 19, 2022Fluid/Blood Leak; Fluid/Blood Leak

  DURING A ATYPICAL LEFT FLUTTER ABLATION, A FLUID LEAK WAS NOTED FROM THE HEMOSTATIC VALVE. ANOTHER SHEATH WAS USED TO COMPLETE THE PROCEDURE WITH NO CONSEQUENCES TO THE PATIENT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15633530 ↗
• MalfunctionAug 24, 2022Material Puncture/Hole; Material Puncture/Hole

  DURING THE PROCEDURE, A PERFORATION IN THE SHEATH WAS NOTED DURING REMOVAL FROM THE PATIENT AT THE FEMORAL SITE. BLOCKAGE OF THE NEEDLE AT THE LEVEL OF THE ILIAC VEIN WAS NOTED RESULTING IN A NEED TO REPLACE THE SHEATH. THERE WERE NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15282305 ↗
• InjuryJan 12, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURING REF: 3008452825-2021-00015, 3005334138-2021-00019, 3008452825-2021-00016. AT THE END OF A LEFT PREMATURE VENTRICULAR CONTRACTION ABLATION PROCEDURE, A PERICARDIAL EFFUSION WAS NOTED VIA TRANSTHORACIC ECHOGRAPHY UNDER GENERAL ANESTHESIA. THE PATIENT BECAME HYPOTENSIVE AND A PERICARDIOCENTESIS WAS PERFORMED WHICH STABILIZED THE PATIENT. A RESTLESS AWAKENING OF THE PATIENT WAS NOTED DURING THE PROCEDURE.

  Patient problems: Cardiac Perforation

  MAUDE report 11155457 ↗
• InjuryNov 12, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURER REFERENCE NUMBER: 3008452825-2019-00529, 3008452825-2019-00530, 3008452825-2019-00540, 3008452825-2019-00541. FOLLOWING COMPLETION OF THE PROCEDURE, THE PATIENT SHOWED SIGNS OF HEMIPLEGIA. LESS THAN 15 MINUTES LATER THE PATIENT HAD NO FURTHER SYMPTOMS AND MAGNETIC RESONANCE IMAGING (MRI) WAS NEGATIVE FOR A CEREBROVASCULAR ACCIDENT (CVA). NO INTERVENTION WAS NEEDED AND THE PATIENT WAS DISCHARGED IN STABLE CONDITION. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICE DURING THE PROCEDURE.

  Patient problems: Stroke/CVA

  MAUDE report 9309261 ↗
• InjuryApr 12, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURING REFERENCE: 3008452825-2019-00176, 3008452825-2019-00177, 2182269-2019-00037. DURING A VENTRICULAR TACHYCARDIA ABLATION PROCEDURE A PERICARDIAL EFFUSION OCCURRED. ACCESS WAS OBTAINED VIA TRANSSEPTAL PUNCTURE AND MAPPING WAS COMPLETED. FOLLOWING MAPPING THE ABLATION CATHETER WAS INTRODUCED. AT THIS TIME THE PATIENT REPORTED CHEST PAIN AND TIGHTNESS. AN ECHOCARDIOGRAM CONFIRMED AN EFFUSION IN THE PERICARDIUM AND THE PATIENT WAS TRANSFERRED TO A CARDIAC SURGEON. HEPARIN WAS REVERSED AND A PERICARDIOCENTESIS WAS PERFORMED TO STABILIZE THE PATIENT. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICE.

  Patient problems: Cardiac Perforation

  MAUDE report 8511134 ↗