Swartz™ 407362Recalls & reported problems

Summary

The FDA's MAUDE database contains 56 adverse event reports that list this exact device (DI 05414734205573), received between Aug 22, 2018 and Aug 21, 2026 — classified as 4 injuries, 52 malfunctions.

The most frequently reported specific device problem is “Gas/Air Leak” (24 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 56 reports, in the reporter's own words as published by the FDA.

• InjuryAug 21, 2026Adverse Event Without Identified Device or Use Problem

  During the MitraClip procedure for mitral regurgitation, a pericardial effusion was noted after transseptal puncture with a BRK needle and advancement of the Swartz sheath. Transseptal puncture was performed with the BRK needle and prior to inserting the MitraClip devices, a pericardial effusion was noted after advancing the sheath into the left atrium. When the pericardial effusion was noted, the patient experiences a drop in blood pressure. The procedure was stopped, and a pericardiocentesis was performed. An attempt was made to continue the MitraClip procedure; however, the patient was hemodynamically unstable and the physician preferred to remove the device and stop the procedure again. The patient was stable after the procedure and there were no further adverse patient health consequences.

  Patient problems: Cardiac Perforation

  MAUDE report 50381149 ↗
• MalfunctionMay 26, 2026Flaked

  DURING AN ATRIAL FIBRILLATION PROCEDURE, A THIN PLASTIC THREAD/PLASTIC SHARD WAS NOTED AFTER INSERTING THE NEEDLE. THE STYLET WAS USED AND THE NEEDLE WAS NOT RESHAPED. 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 25285385 ↗
• MalfunctionMay 7, 2026Gas/Air Leak

  DURING AN ATRIAL FIBRILLATION PFA PROCEDURE, AFTER CATHETER INSERTION IN THE RIGHT ATRIUM, AN AIR LEAK WAS NOTED FROM THE SHEATH HEMOSTATIC 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 25113230 ↗
• MalfunctionApr 10, 2026Material Puncture/Hole

  DURING THE ATRIAL FIBRILLATION PROCEDURE, JUST BEFORE TRANSSEPTAL PUNCTURE, THE NEEDLE PUNCTURED THE SHEATH. THE NEEDLE DID NOT FIT INTO THE SHEATH. ON X-RAY, IT WAS SEEN THAT THE NEEDLE CAME OUT OF THE SHEATH, NOT AT THE END OF THE SHEATH BUT BEFORE THE SHEATH. THE SHEATH AND NEEDLE WERE REPLACED. THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24841718 ↗
• MalfunctionMar 31, 2026Gas/Air Leak

  DURING THE ATRIAL FIBRILLATION PROCEDURE, AIR LEAKED FROM THE VALVE OF THE SHEATH. 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 24746234 ↗
• MalfunctionMar 2, 2026Gas/Air Leak

  DURING AN ATRIAL FIBRILLATION PROCEDURE, WHILE ASPIRATING, AIR BUBBLES WERE OBSERVED IN THE TUBE. MULTIPLE ATTEMPTS WERE MADE TO REMOVE THE AIR, BUT THE BUBBLES REMAINED. THE SHEATH WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24482576 ↗
• MalfunctionFeb 20, 2026Gas/Air Leak

  DURING THE ATRIAL FIBRILLATION PROCEDURE, AFTER INSERTING THE SHEATH INTO THE LEFT ATRIUM AND INSERTING THE ADVISOR HD GRID X CATHETER THROUGH THE SHEATH, AIR WAS ASPIRATED WHEN PERFORMING ASPIRATION FROM THE SIDE PORT WHILE MAPPING. ALTHOUGH SEVERAL ATTEMPTS WERE MADE TO ASPIRATE THE AIR, IT COULD NOT BE COMPLETELY REMOVED. 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 24404964 ↗
• MalfunctionJan 28, 2026Gas/Air Leak

  DURING THE ATRIAL FIBRILLATION PROCEDURE, AIR WAS ASPIRATED FROM THE INTRODUCER. AFTER THE DEVICE WAS INSERTED INTO THE PATIENT, WHEN ASPIRATING BLOOD FROM THE PORT WITH A SYRINGE, AIR WAS ASPIRATED. 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 24206135 ↗
• MalfunctionJan 20, 2026Difficult to Remove; Gas/Air Leak

  DURING THE AF PROCEDURE, AFTER THE FARADRIVE (BOSTON SCIENTIFIC) WAS INSERTED INTO THE INTRODUCER, IT WAS ADVANCED INTO THE LEFT ATRIUM VIA THE SEPTUM, AND THEN THE ADVISOR HD GRID WAS ADVANCED. IT WAS NOTED THAT AIR WAS ASPIRATED WHEN DRAWING BLOOD FROM THE PORT. 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 24118035 ↗
• MalfunctionDec 16, 2025Fluid/Blood Leak; Fluid/Blood Leak

  DURING AN ATRIAL FIBRILLATION PROCEDURE, BLOOD LEAKED FROM THE HEMOSTATIC VALVE WHEN A CATHETER WAS INSERTED. 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 23823887 ↗
• MalfunctionNov 11, 2025Fluid/Blood Leak; Fluid/Blood Leak

  DURING THE ATRIAL FIBRILLATION PROCEDURE, THERE WAS A BLOOD LEAK FROM THE HEMOSTASIS VALVE. 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 23526712 ↗
• MalfunctionOct 28, 2025Fluid/Blood Leak; Fluid/Blood Leak

  DURING THE ATRIAL FIBRILLATION PROCEDURE, THE GUIDEWIRE WAS INSERTED INTO THE VEIN AND AFTER ADVANCING THE INTEGRATED INTRODUCER/DILATOR, BLOOD LEAKED FROM THE HEMOSTASIS VALVE. 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 23406211 ↗
• MalfunctionJul 31, 2025Gas/Air Leak; Gas/Air Leak

  DURING AN ATRIAL FIBRILLATION PROCEDURE, AN AIR LEAK WAS NOTED WHILE ASPIRATING BLOOD FROM THE PORT USING A SYRINGE. WITHOUT PERFORMING A NEW PUNCTURE, THE WIRE WAS RETAINED IN THE INITIAL PUNCTURE SITE, AND A REPLACEMENT INTRODUCER WAS INSERTED. THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT. NO AIR MOVEMENT INTO THE PATIENT WAS CONFIRMED. THE HOSPITAL DISCARDED THE REPORTED INTRODUCER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22681208 ↗
• MalfunctionJul 17, 2025Gas/Air Leak; Gas/Air Leak

  DURING AF PROCEDURE, THERE WAS AN AIR LEAK NOTED FROM THE VALVE. THE ISSUE WAS OBSERVED DURING INITIAL INSERTION AND THERE WERE NO ADVERSE EFFECTS TO THE PATIENT. WHEN THE SHEATH WAS REPLACED, THE ISSUE WAS RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22536445 ↗
• MalfunctionJun 12, 2025Fluid/Blood Leak; Fluid/Blood Leak

  DURING THE ATRIAL FIBRILLATION PROCEDURE, WHEN INSERTING THE SHEATH INTO THE PATIENT¿S BODY AFTER PUNCTURE, BLOOD LEAKED FROM THE HEMOSTASIS VALVE. THE DILATOR, GUIDEWIRE, AND CATHETER WERE INSERTED INTO THE VALVE AND, THE BLOOD LEAK OCCURRED IMMEDIATELY AFTER THE CATHETER WAS INSERTED INTO THE PATIENT¿S BODY. NO RESISTANCE WAS NOTED WITH THE FIRST DEVICE INSERTED INTO THE SHEATH¿S HEMOSTATIC VALVE. THE INTRODUCER WAS REPLACED, AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT. NO AIR MOVEMENT INTO THE PATIENT WAS CONFIRMED. NO ADDITIONAL PUNCTURE AT THE ACCESS SITE WAS NECESSARY DURING SHEATH REPLACEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22193968 ↗
• MalfunctionJan 20, 2025Gas/Air Leak; Gas/Air Leak

  DURING THE ATRIAL FIBRILLATION PROCEDURE, THE SHEATH WAS INSERTED INTO THE RIGHT ATRIUM AND NEGATIVE PRESSURE WAS APPLIED FOR FLUSHING BEFORE INSERTING THE CATHETER, AIR WAS ASPIRATED. SINCE THE AMOUNT OF AIR WAS NOT LARGE, THE PROCEDURE WAS COMPLETED WITHOUT REPLACING THE DEVICE AND THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21191670 ↗
• MalfunctionOct 11, 2024Gas/Air Leak; Gas/Air Leak

  DURING THE ATRIAL FIBRILLATION, AN AIR LEAK OCCURRED. THE DEVICE WAS EXCHANGED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20426763 ↗
• MalfunctionAug 28, 2024Difficult to Insert; Material Puncture/Hole; Difficult to Insert; Material Puncture/Hole

  DURING AN ATRIAL FIBRILLATION PROCEDURE, THE SHEATH WAS PERFORATED DURING USE. A BRK NEEDLE WAS INSERTED INTO THE SHEATH BUT COULD NOT BE PUSHED THROUGH DISTAL END. AFTER APPLYING MORE PRESSURE, THE BRK NEEDLE PERFORATED THE SHEATH. THE SHEATH WAS REPLACED AND THE ISSUE WAS RESOLVED. THE PROCEDURE WAS COMPLETED WITH NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20091384 ↗
• InjuryApr 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A PULMONARY VEIN ISOLATION PROCEDURE, A PERICARDIAL EFFUSION OCCURRED IN THE LEFT ATRIAL APPENDAGE. THE PATIENT BECAME HYPOTENSIVE DURING THE TRANSSEPTAL PUNCTURE, AND A PERICARDIAL EFFUSION WAS NOTED ON THE ULTRASOUND. THE SIZE OF THE PERICARDIAL EFFUSION WAS MEASURED USING ULTRASOUND EVERY 10 MINUTES. BECAUSE THE PERICARDIAL EFFUSION DID NOT INCREASE, NO PERICARDIOCENTESIS WAS PERFORMED. THE PROCEDURE WAS COMPLETED, AND THE PATIENT WAS STABILIZED. IT WAS SUSPECTED THAT THE DILATOR OF THE SHEATH HAD PERFORATED THE ATRIAL APPENDAGE DURING THE TRANSSEPTAL PUNCTURE. THERE WERE NO ALLEGED PERFORMANCE ISSUES WITH ANY ABBOTT DEVICES.

  Patient problems: Cardiac Perforation

  MAUDE report 19210576 ↗
• MalfunctionApr 19, 2024Gas/Air Leak; Gas/Air Leak

  DURING AN ATRIAL FIBRILLATION PROCEDURE, AN AIR LEAK WAS NOTED. THE SHEATH WAS INSERTED INTO THE PATIENT AND A NON ABBOTT (LASSO, JOHNSON & JOHNSON) CATHETER WAS INSERTED INTO THE SHEATH. WHEN ATTEMPTING TO FLUSH, AIR WAS ASPIRATED. ATTEMPTS TO ASPIRATE THE AIR WAS PERFORMED SEVERAL TIMES WITH NO RESOLUTION. 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 19143507 ↗
• MalfunctionFeb 5, 2024Fluid/Blood Leak; Fluid/Blood Leak

  DURING AN ATRIAL FIBRILLATION PROCEDURE, BLOOD LEAKAGE WAS FOUND FROM THE HEMOSTATIC VALVE. THE DEVICE WAS REPLACED, AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18641937 ↗
• MalfunctionNov 17, 2023Fracture; Material Frayed; Fracture; Material Frayed

  RELATED MANUFACTURE REF: 3005334138-2023-00539. DURING AN ATYPICAL ATRIAL FLUTTER ABLATION PROCEDURE, A CUT WAS NOTED ON THE SHEATH WHICH REQUIRED INTERVENTION FROM A VASCULAR SURGEON TO EXTRACT THE SHEATH PROPERLY FROM THE RIGHT FEMORAL VEIN. THE PROCEDURE WAS INTERRUPTED WITH NO CONSEQUENCES TO THE PATIENT.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18160131 ↗
• MalfunctionSep 28, 2023Fluid/Blood Leak; Fluid/Blood Leak

  DURING THE ATRIAL FIBRILLATION PROCEDURE, A BLOOD LEAK WAS NOTED FROM 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 17831160 ↗
• MalfunctionJul 7, 2023Gas/Air Leak; Gas/Air Leak

  DURING THE ATRIAL FIBRILLATION PROCEDURE, AN AIR LEAK OCCURRED. THE INTRODUCER WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT. AFTER THE SHEATH WAS INSERTED INTO THE LEFT ATRIUM, THE MAPPING CATHETER WAS INSERTED INTO THE SHEATH AND REMOVED DURING MAPPING. NEGATIVE PRESSURE WAS THEN APPLIED FROM THE SIDE PORT BUT IT WAS NOTED THAT AIR WAS ASPIRATED. THE AIR WAS ASPIRATED SEVERAL TIMES, BUT NO RESOLUTION. THE INTRODUCER WAS REPLACED, AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT. AIR INTRUSION INTO THE PATIENT HAS NOT BEEN CONFIRMED. NO ADDITIONAL VENIPUNCTURE OR SEPTAL PUNCTURE WAS PERFORMED TO REPLACE THE SHEATH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17283599 ↗
• MalfunctionJun 5, 2023Fluid/Blood Leak; Gas/Air Leak; Fluid/Blood Leak; Gas/Air Leak

  DURING AN ATRIAL FIBRILLATION ABLATION PROCEDURE, A BLOOD LEAK WAS NOTED FROM THE THREE-WAY STOPCOCK OF THE SIDE PORT. THE THREE-WAY STOPCOCK WAS RETIGHTENED, BUT WITH NO RESOLUTION. 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 17058810 ↗