Swartz™ 407452Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 05414734205764), received between Feb 5, 2019 and Apr 2, 2026 — classified as 3 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (2 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 2, 2026Fluid/Blood Leak

  DURING THE PROCEDURE, THE SHEATH LEAKED. 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 24764086 ↗
• MalfunctionMar 2, 2026Fluid/Blood Leak

  DURING A PULMONARY VEIN ISOLATION PROCEDURE, BLOOD LEAKED FROM THE HEMOSTASIS VALVE. 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 24492321 ↗
• MalfunctionMar 2, 2026Gas/Air Leak

  DURING AN ATRIAL FIBRILLATION PROCEDURE, AFTER PERFORMING TRANSSEPTAL PUNCTURE WHILE FLUSHING, AIR BUBBLES WERE OBSERVED. THE SHEATH WAS REPLACED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24485007 ↗
• MalfunctionDec 16, 2025Material Puncture/Hole; Material Puncture/Hole

  DURING THE TRANSSEPTAL PUNCTURE, THE DILATOR AND THE SHEATH WERE PUNCTURED SEVERAL TIMES BY THE NEEDLE IN THE AREA OF THE CURVATURE. BOTH THE NEEDLE AND THE SHEATH WERE REPLACED. AN AGILIS SHEATH WAS USED WHICH RESOLVED THE ISSUE AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23824632 ↗
• InjuryJul 25, 2024Material Separation; Material Separation

  DURING THE ATRIAL FIBRILLATION PROCEDURE, PART OF THE SHEATH BROKE OFF FROM THE DEVICE REQUIRING SURGICAL INTERVENTION TO RETRIEVE IT. ALL PIECES WERE ACCOUNTED FOR WITH FLUOROSCOPY. THE PHYSICIAN CANCELLED THE PROCEDURE DUE TO THE ISSUE WITH THE SHEATH.

  Patient problems: Foreign Body In Patient

  MAUDE report 19825939 ↗
• InjuryApr 29, 2021Fracture; Difficult to Insert; Material Separation; Fracture; Difficult to Insert; Material Separation

  DURING A VENTRICULAR TACHYCARDIA PROCEDURE, THE GRAY SOFT TIP OF THE SHEATH DETACHED IN PATIENT AND TWO DAYS LATER, THE PATIENT EXPERIENCED STROKE SYMPTOMS. AN MRI WAS CONDUCTED TO INITIALLY DIAGNOSE THE STROKE. DURING THE PROCEDURE, DIFFICULTY WAS NOTED WHEN INSERTING A NON-ABBOTT 8.5F CATHETER INTO THE INTRODUCER AFTER MAPPING AND ABLATION WAS CONDUCTED. ADDITIONALLY, THE 8.5F NON-ABBOTT CATHETER WAS DIFFICULT TO FULLY INSERT THROUGH THE SHEATH AND MANIPULATING THE CATHETER IN THE PATIENT FELT ABNORMAL. THE PHYSICIAN REMOVED THE SHEATH AND CATHETER TOGETHER FROM THE PATIENT AND UPON REMOVAL, THE GRAY SOFT TIP OF THE SHEATH WAS NOTED TO HAVE BEEN DETACHED. THE REMAINDER OF THE SHEATH TIP WAS SHEARED AND HANGING AT THE END OF THE SHEATH. NO INTERVENTION WAS ADMINISTERED AS THE GRAY SOFT TIP PIECES HAD APPEARED TO DISINTEGRATE IN THE PATIENT AND ALL PIECES WERE NOT ACCOUNTED FOR SINCE THEY COULD NOT BE VISUALIZED DUE TO BEING OPAQUE. TWO DAYS FOLLOWING THE PROCEDURE THE PATIENT EXPERIENCED STOKE SYMPTOMS OF BLURRED VISION OF THE LEFT EYE, HOWEVER NO INTERVENTION WAS NOTED TO HAVE BEEN CONDUCTED. FURTHER INFORMATION REGARDING PRE ANTICOAGULATION AND TRANSESOPHAGEAL ECHOCARDIOGRAPHY A

  Patient problems: Foreign Body Embolism; Stroke/CVA

  MAUDE report 11749586 ↗
• InjuryFeb 5, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURING REF: 3008452825-2019-00041, 3008452825-2019-00042, 3008452825-2019-00043, 3008452825-2019-00044, 3005334138-2019-00050, 3005334138-2019-00051, 3008452825-2019-00045. FOLLOWING A PULMONARY VEIN ISOLATION PROCEDURE, A PERICARDIAL EFFUSION WAS NOTED VIA ECHOCARDIOGRAPHY. A PERICARDIOCENTESIS WAS PERFORMED TO STABILIZE THE PATIENT. NO PATIENT SYMPTOMS WERE NOTED THROUGHOUT THE PROCEDURE AND THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICE.

  Patient problems: Cardiac Perforation

  MAUDE report 8304822 ↗