Swartz™ 407455Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 05414734205795), received between Dec 19, 2018 and May 9, 2025 — classified as 5 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Material Puncture/Hole” (3 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 9, 2025Fluid/Blood Leak; Fluid/Blood Leak

  DURING AN ATRIAL FIBRILLATION PROCEDURE, BLOOD LEAKED FROM THE HEMOSTASIS VALVE WHEN APPLYING NEGATIVE PRESSURE. 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 21991096 ↗
• MalfunctionApr 30, 2025Fluid/Blood Leak; Fluid/Blood Leak

  DURING AN ATRIAL FIBRILLATION PROCEDURE, A BLOOD LEAK WAS NOTED FROM THE HEMOSTASIS VALVE WHEN APPLYING NEGATIVE PRESSURE. 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 21935679 ↗
• InjuryAug 8, 2024Material Separation; Material Separation

  DURING A LEFT ATRIAL APPENDAGE OCCLUSION (LAAO) PROCEDURE, THE SHEATH BROKE APART AND REMAINED IN THE PATIENT, REQUIRING MEDICAL INTERVENTION TO REMOVE THE PIECES. THE SHEATH WAS BEING USED TO IMPLANT A WATCHMAN DEVICE. AFTER TRANSEPTAL ACCESS WAS ACHIEVED USING THE SHEATH AND A BRK-1 NEEDLE, A NON-ABBOTT (TORAY) GUIDEWIRE WAS ADVANCED INTO THE LEFT ATRIUM THROUGH THE SHEATH. THE SHEATH WAS THEN REMOVED TO EXCHANGE FOR THE WATCHMAN DEPLOYMENT SHEATH. WHEN THE SHEATH WAS REMOVED FROM THE PATIENT, THE DEVICE BROKE, CRACKING IN SEVERAL PLACES. THE TIP OF THE DEVICE WAS ALSO BROKEN OFF, REMAINING IN THE PATIENT, STILL ON THE GUIDEWIRE. THE TIP WAS SUCCESSFULLY RETRIEVED USING ANOTHER SHEATH AND A BALLOON AND GUIDED BY FLUOROSCOPY AND ICE. THE SHEATH WAS REPLACED BY AN SL1, THE PROCEDURE WAS THEN RESTARTED AND WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 19937731 ↗
• MalfunctionJul 16, 2024Gas/Air Leak; Gas/Air Leak

  DURING AN ATRIAL FIBRILLATION PROCEDURE, WHEN THE SHEATH WAS INSERTED INTO THE PATIENT AND SUCTION WAS APPLIED FROM THE SIDE PORT BEFORE CATHETER INSERTION, AIR WAS ASPIRATED. THE SHEATH WAS REPLACED, AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT. THE HOSPITAL DISCARDED THE REPORTED SHEATH. AIR CONTAMINATION INTO THE PATIENT HAS NOT BEEN CONFIRMED. NO ADDITIONAL VENIPUNCTURE WAS PERFORMED. ONLY THE DILATOR WAS INSERTED INTO THE HEMOSTASIS VALVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19755996 ↗
• MalfunctionNov 7, 2023Material Puncture/Hole; Material Puncture/Hole

  DURING THE PROCEDURE, THE NEEDLE DID NOT ADVANCE AS EXPECTED INTO THE SHEATH. UPON REMOVAL FROM THE PATIENT, IT WAS NOTED THAT THE NEEDLE HAD PUSHED INTO THE SIDE WALL. THE SHEATH WAS REPLACED WITH NO CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18084885 ↗
• MalfunctionJan 9, 2023Material Puncture/Hole; Material Puncture/Hole

  THIS REPORT IS TO ADVISE OF AN EVENT OBSERVED DURING ANALYSIS WHICH REVEALED PUNCTURE IN THE SHEATH AND DILATOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16123675 ↗
• MalfunctionAug 30, 2021Gas/Air Leak; Gas/Air Leak

  DURING THE ATRIAL FIBRILLATION PROCEDURE, AN AIR LEAK OCCURRED. AFTER THE INTRODUCER WAS INSERTED, AND THE DILATOR AND GUIDE WIRE WERE REMOVED AND FLUSHED. AIR WAS ASPIRATED CONTINUOUSLY EVEN AFTER FLUSHING. 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 12385220 ↗
• InjuryDec 2, 2020Material Separation; Material Separation

  THE DEVICE WAS RETRIEVED WITH A HEMOSTAT BY THE VASCULAR SURGEONS WITH ALL PIECES ACCOUNTED FOR VIA FLUOROSCOPY.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 10935403 ↗
• InjurySep 21, 2020Difficult to Insert; Material Puncture/Hole; Material Twisted/Bent; Difficult to Insert; Material Puncture/Hole; Material Twisted/Bent

  DURING AN ATRIAL FIBRILLATION PROCEDURE, THE INTRODUCER WAS UNABLE TO ADVANCE ACROSS THE ATRIAL SEPTUM WHILE ATTEMPTING TO GAIN TRANSSEPTAL ACCESS AND A CLINICALLY SIGNIFICANT DELAY WAS NOTED. THE INTRODUCER WAS REMOVED AND THE DISTAL END OF THE SHEATH WAS NOTED TO BE BENT AND PUNCTURED. THE INTRODUCER WAS REPLACED AND THE PROCEDURE WAS COMPLETED. A FIFTEEN MINUTE CLINICALLY SIGNIFICANT DELAY WAS NOTED DUE TO THE ISSUE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10563918 ↗
• InjuryJul 11, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MANUFACTURING RELATED REF: 3008452825-2019-00329, 3005334138-2019-00371, 3008452825-2019-00328. DURING THE PULMONARY VEIN ISOLATION (PVI) ABLATION PROCEDURE, THE PATIENT EXPERIENCED A PERICARDIAL EFFUSION. AN ICE CATHETER WAS USED TO VIEW THE VENTRICLES AND PERICARDIUM THROUGHOUT THE PROCEDURE AND THE USER NOTED A SMALL EFFUSION DEVELOPING DURING THE LEFT VEIN WIDE ATRIAL CIRCUMFERENTIAL ABLATION. THE EFFUSION WAS IN THE LEFT ATRIUM AND THE PATIENT EXPERIENCED REDUCED BLOOD PRESSURE AND CARDIAC TAMPONADE. THE PROCEDURE WAS STOPPED AND PROTAMINE WAS ADMINISTERED AND A PERICARDIOCENTESIS WAS PERFORMED WITH THE PLACEMENT OF A PERICARDIAL DRAIN. THERE WERE NO PERFORMANCE ISSUES WITH AN ABBOTT DEVICE.

  Patient problems: Cardiac Perforation; Cardiac Tamponade

  MAUDE report 8781895 ↗
• InjuryDec 19, 2018Material Separation; Material Separation

  DURING AN ATRIAL FIBRILLATION PROCEDURE, DIFFICULTY WAS NOTED DURING TRANSSEPTAL PUNCTURE. THE DEVICE WAS THEN ATTEMPTED TO BE REMOVED AND THE PROCEDURE CANCELLED, BUT THE SHEATH WAS UNABLE TO BE REMOVED FROM THE ACCESS SITE. AFTER REMOVING THE SHEATH, IN AN UNKNOWN MANNER, IT WAS OBSERVED TO BE SEPARATED WITH THE BRAIDING UNWOUND.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8181504 ↗