Swartz™ 407450Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 05414734205740), received between Oct 14, 2020 and Nov 17, 2025 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Gas/Air Leak” (5 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 17, 2025Gas/Air Leak; Gas/Air Leak

  DURING AN ATRIAL FIBRILLATION PVI PROCEDURE, WHILE ASPIRATING AIR WAS DRAWN IN. THE SHEATH WAS REPLACED BUT THE ISSUE OCCURRED AGAIN. THE SECOND SHEATH WAS REPLACED WITH AN AGILIS SHEATH AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23576544 ↗
• MalfunctionNov 17, 2025Gas/Air Leak; Gas/Air Leak

  DURING AN ATRIAL FIBRILLATION PVI PROCEDURE, WHILE ASPIRATING, AIR WAS DRAWN IN. THE SHEATH WAS REPLACED BUT THE ISSUE OCCURRED AGAIN. THE SECOND SHEATH WAS REPLACED WITH AN AGILIS SHEATH AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23573333 ↗
• MalfunctionJan 9, 2023Gas/Air Leak; Gas/Air Leak

  RELATED MANUFACTURING REFERENCE: 3005334138-2022-00707. DURING ATRIAL FIBRILLATION ABLATION PROCEDURE, AN AIR LEAK WAS NOTED WHEN THE TWO SHEATHS WERE INSERTED INTO THE RIGHT ATRIUM OF THE PATIENT. PRIOR TO INSERTING THE CATHETERS AND A TRANSSEPTAL NEEDLE, THE AIR WAS ASPIRATED INTO SYRINGES THAT CONNECTED TO THE EXTENSION PORT OF THE SHEATHS. SEVERAL ASPIRATIONS WERE ATTEMPTED WITH THE SHEATHS THE AIR WAS STILL ASPIRATED INTO THE SYRINGES. THE TWO SHEATHS WERE REPLACED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL FEMORAL VEIN PUNCTURE WAS REQUIRED FOR REPLACING THE SHEATH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16126790 ↗
• MalfunctionJan 9, 2023Gas/Air Leak; Gas/Air Leak

  DURING AN ATRIAL FIBRILLATION ABLATION PROCEDURE, AN AIR LEAK WAS NOTED. THE SHEATH WAS INSERTED INTO THE RIGHT ATRIUM OF THE PATIENT AND PRIOR TO INSERTING THE CATHETERS AND A TRANSSEPTAL NEEDLE, IT WAS NOTED THAT AIR WAS ASPIRATED INTO A SYRINGE THAT CONNECTED TO THE EXTENSION PORT OF THE SHEATH. SEVERAL ASPIRATIONS WERE ATTEMPTED BUT THE AIR WAS STILL ASPIRATED INTO THE SYRINGE. THE SHEATH WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL FEMORAL VEIN PUNCTURE WAS REQUIRED FOR REPLACING THE SHEATH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16123252 ↗
• MalfunctionJan 9, 2023Gas/Air Leak; Gas/Air Leak

  RELATED MANUFACTURING REFERENCE: 3005334138-2022-00708. DURING ATRIAL FIBRILLATION ABLATION PROCEDURE, AN AIR LEAK WAS NOTED WHEN THE TWO SHEATHS WERE INSERTED INTO THE RIGHT ATRIUM OF THE PATIENT. PRIOR TO INSERTING THE CATHETERS AND A TRANSSEPTAL NEEDLE, THE AIR WAS ASPIRATED INTO SYRINGES THAT CONNECTED TO THE EXTENSION PORT OF THE SHEATHS. SEVERAL ASPIRATIONS WERE ATTEMPTED WITH THE SHEATHS THE AIR WAS STILL ASPIRATED INTO THE SYRINGES. THE TWO SHEATHS WERE REPLACED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL FEMORAL VEIN PUNCTURE WAS REQUIRED FOR REPLACING THE SHEATH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16123038 ↗
• InjuryOct 14, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURER REFERENCE NUMBER: 3008452825-2020-00549. DURING A PULMONARY VEIN ISOLATION ABLATION PROCEDURE, ACCESS WAS MADE VIA THE FEMORAL VEIN AND CATHETERS WERE PLACED INTO THE RIGHT ATRIUM. A DOUBLE TRANSSEPTAL ACCESS WAS PERFORMED TO ACCESS THE LEFT ATRIUM. MAPPING OF THE LEFT ATRIUM WAS STARTED WITH A NON-ABBOTT MAPPING CATHETER, BUT WHEN ATTEMPTING TO MAP WITH THE ABLATION CATHETER IT WAS NOTED THAT THE ANGLE OF THE TRANSSEPTAL SITES WERE NOT WORKABLE SO ANOTHER TRANSSEPTAL ACCESS WAS OBTAINED. AFTER THE NEW TRANSSEPTAL PUNCTURE WAS PERFORMED WITH THE ABBOTT NEEDLE AND INTRODUCER, THE PATIENT BECAME HYPOTENSIVE. HEPARIN WAS STOPPED, ADRENALINE WAS GIVEN, AND CPR WAS PERFORMED. CARDIAC ECHOGRAPHY AND TRANS-ESOPHAGEAL ECHOCARDIOGRAM SHOWED NO CARDIAC TAMPONADE. THE PATIENT WAS STABILIZED AND TRANSFER TO ICU FOR MONITORING. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICE.

  Patient problems: Low Blood Pressure/ Hypotension

  MAUDE report 10676741 ↗