Swartz™ 407451Recalls & reported problems

Summary

The FDA's MAUDE database contains 728 adverse event reports that list this exact device (DI 05414734205757), received between Jun 15, 2018 and Sep 28, 2026 — classified as 5 deaths, 93 injuries, 630 malfunctions.

The most frequently reported specific device problem is “Gas/Air Leak” (309 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 728 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026Gas/Air Leak

  During the atrial fibrillation procedure, an air leak was noted. 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 50916432 ↗
• MalfunctionSep 25, 2026Flaked

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50903208 ↗
• DeathSep 24, 2026Difficult to Insert; Improper or Incorrect Procedure or Method; Material Twisted/Bent

  During a PFA procedure, air ingress, ST elevation, bradycardia, and cerebral hypoxia occurred which resulted in the patient transferring to the ICU and receiving hyperbaric therapy twice. The patient later passed away in the neurology ICU. For the procedure, the patient was sedated with fentanyl and remiMizolam. The transseptal puncture progressed normally with a jump to fosa ovalis and an expected IBP curve form for LA pressure. After the transseptal puncture, the SL0 guidewire was placed in the LSPV of the left atrium. The dilator and SL0 sheath were removed from the patient. The Agilis 13F and dilator were then advanced over the SL0 guidewire into the IVC. However, resistance was felt before reaching the heart. Fluoroscopy noted that the SL0 guidewire was kinked below the diaphragm. The Agilis 13F and dilator were removed from the IVC. The SL0 sheath and dilator were flushed, re-assembled, and re-inserted into the IVC along the guidewire. The SL0 and dilator also could not pass the kinked guidewire. The SL0 and dilator were removed again. The SL0 sheath was flushed again, and only the SL0 sheath was advanced over the guidewire without the dilator. The SL0 was able to advance pas

  Patient problems: Air Embolism; Arrhythmia; Stroke/CVA

  MAUDE report 50889804 ↗
• InjurySep 24, 2026Adverse Event Without Identified Device or Use Problem

  During the atrial fibrillation procedure, a cardiac tamponade requiring a thoracotomy was noted while performing left atrial mapping after transseptal puncture. Transseptal puncture was performed using a Swartz sheath and RF needle. An HD Grid catheter was inserted and left atrial mapping was being performed when the patients' blood pressure was noted to be dropping and a cardiac tamponade was confirmed via echocardiography. Hemostasis was achieved via a thoracotomy. The procedure was completed without replacing the device. The patient is stable and recovered.

  Patient problems: Cardiac Perforation

  MAUDE report 50885527 ↗
• MalfunctionSep 24, 2026Gas/Air Leak

  During an atrial fibrillation procedure, air was introduced from the Swartz SL0 sheath. It was noted that a syringe was attached to the side port to aspirate when the air entered the sheath. The sheath was exchanged, and the procedure was completed with no adverse patient consequences.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50882270 ↗
• MalfunctionSep 23, 2026Gas/Air Leak

  During the atrial fibrillation procedure, an air leak was noted on the Swartz sheath. The Swartz sheath was exchanged, and the procedure was completed with no adverse patient health consequences.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50869821 ↗
• MalfunctionSep 22, 2026Gas/Air Leak

  During a paroxysmal supraventricular tachycardia procedure, an air leak was noted on the Swartz sheath. The Swartz sheath was exchanged, and the procedure was completed with no adverse patient health consequences.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50858612 ↗
• MalfunctionSep 22, 2026Gas/Air Leak

  During an atrial fibrillation procedure, after performing the transseptal puncture, while aspirating blood through the tube, air bubbles were aspirated. The sheath was replaced to resolve the issue. The procedure was completed with no adverse patient consequences.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50854640 ↗
• MalfunctionAug 19, 2026Gas/Air Leak

  During an atrial fibrillation procedure, an abnormally large amount of air was aspirated from the Swartz SL0 introducer. It was noted that even after repeated aspiration, all of the air could not be removed from the introducer. 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 50321513 ↗
• MalfunctionAug 6, 2026Gas/Air Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50158438 ↗
• MalfunctionJun 3, 2026Gas/Air Leak

  DURING THE ATRIAL FIBRILLATION PROCEDURE, AN AIR LEAK FROM THE SHEATH WAS NOTED AFTER TRANSSEPTAL PUNCTURE. BOTH THE DILATOR AND NEEDLE WERE RETRIEVED AND ASPIRATION WAS PERFORMED. BUBBLES WERE NOTED IN THE SYRINGE. 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 25374262 ↗
• InjuryJun 1, 2026Material Frayed; Difficult to Insert; Material Twisted/Bent

  DURING THE PAROXYSMAL ATRIAL FIBRILLATION PROCEDURE, INSERTION DIFFICULTIES RESULTED IN THE NEED FOR AN ADDITIONAL FEMORAL ACCESS SITE. ACCESS WAS GAINED IN THE RIGHT GROIN, AND THE INCLUDED GUIDEWIRE WAS INSERTED INTO THE PATIENT. THE INTRODUCER WITH THE DILATOR ASSEMBLED WAS THEN ADVANCED OVER THE GUIDEWIRE. THE INTRODUCER HAD BEEN INSERTED APPROXIMATELY 10CM WHEN FURTHER ADVANCEMENT BECAME DIFFICULT. FLUOROSCOPY AND ULTRASOUND REVEALED THAT THE GUIDEWIRE HAD KINKED AT THE TIP OF THE DILATOR. THE INTRODUCER WAS WITHDRAWN FROM THE PATIENT, LEAVING THE GUIDEWIRE IN PLACE; HOWEVER, THE KINK IN THE GUIDEWIRE DID NOT RESOLVE. THE GUIDEWIRE WAS REMOVED FROM THE PATIENT AND DETERMINED TO BE INTACT. FRAYING AT THE DILATOR TIP WAS ALSO OBSERVED. A LINEAR ULTRASOUND PROBE HAD BEEN USED BUT THE PUNCTURE WAS PERFORMED AT A RELATIVELY STEEP ANGLE TO THE PATIENT, AND THE VESSEL COURSE WAS DEEPER THAN USUAL WHICH IS CONSIDERED A POSSIBLE CONTRIBUTING FACTOR. THE INTRODUCER WAS REPLACED AND A NEW PUNCTURE SITE WAS USED FOR INSERTION. THE PROCEDURE WAS COMPLETED WITH NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25349865 ↗
• MalfunctionMay 26, 2026Fluid/Blood Leak

  DURING THE AF PROCEDURE, IT WAS NOTED THAT BLOOD LEAKED FROM THE HEMOSTASIS VALVE AFTER TRANSSEPTAL PUNCTURE WAS PERFORMED. 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 25284738 ↗
• InjuryMay 26, 2026Adverse Event Without Identified Device or Use Problem

  DURING AN ATRIAL FIBRILLATION PROCEDURE, PRIOR TO THE TRANSSEPTAL PUNCTURE, THE ECHOCARDIOGRAPHY SHOWED A PERICARDIAL EFFUSION AROUND THE VENTRICLES OF THE HEART, REQUIRING A PERICARDIOCENTESIS. THE FIRST TRANSSEPTAL PUNCTURE WAS COMPLETED USING A SWARTZ SHEATH AND BRK NEEDLE. A SECOND TRANSSEPTAL PUNCTURE WAS THEN PERFORMED USING AN AGILIS SHEATH AND A TACTICATH SE CATHETER, USING ECHOCARDIOGRAPHY AS GUIDANCE. MAPPING OF THE LEFT ATRIUM WAS COMPLETED USING AN ADVISOR HD GRID CATHETER. ABLATION WAS SUBSEQUENTLY INITIATED WITH THE TACTICATH SE CATHETER AT THE RIDGE OF THE LEFT PULMONARY VEIN. ONLY ANTERIOR ABLATION LESIONS WERE DELIVERED; NO POSTERIOR ABLATION WAS PERFORMED. THE PATIENT THEN BECAME HYPOTENSIVE AND THE ECHOCARDIOGRAM CONFIRMED PRESENCE OF THE SAME PERICARDIAL EFFUSION PREVIOUSLY OBSERVED AT THE BEGINNING OF THE PROCEDURE. PERICARDIAL DRAINAGE WAS PERFORMED, RESULTING IN THE REMOVAL OF A TOTAL OF 300 ML OF BLOOD AND PATIENT REMAINED STABLE WHEN THEY LEFT THE ROOM. AS THE PERICARDIAL EFFUSION WAS NOTICED BEFORE THE TRANSSEPTAL PUNCTURE AND THEN BEFORE THE LEFT ATRIUM ACCESS, THE PHYSICIAN ALLEGES THAT THIS TAMPONADE COULD BE CAUSED BY THE GUIDEWIRES WHEN THEY WERE INSE

  Patient problems: Cardiac Perforation

  MAUDE report 25282937 ↗
• MalfunctionMay 21, 2026Gas/Air Leak

  DURING AN AF PROCEDURE, CONTINUOUS AIR LEAKAGE FROM THE HEMOSTATIC VALVE WAS OBSERVED. THE SHEATH WAS REPLACED, AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT. THE HOSPITAL DISCARDED THE REPORTED SHEATH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25247962 ↗
• MalfunctionMay 21, 2026Gas/Air Leak

  DURING AN ATRIAL FIBRILLATION PROCEDURE, IMMEDIATELY AFTER SHEATH INSERTION, AIR WAS CONTINUOUSLY ASPIRATED DURING AIR REMOVAL. 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 25245716 ↗
• MalfunctionMay 19, 2026Gas/Air Leak

  DURING AN ATRIAL FIBRILLATION PROCEDURE, AN AIR LEAK WAS NOTED ON THE SWARTZ INTRODUCER. AFTER INSERTION WHILE DRAWING BLOOD, AIR WAS ASPIRATED. THE SWARTZ INTRODUCER WAS EXCHANGED AND THE ISSUE RESOLVED. THE PROCEDURE WAS COMPLETED WITH NO ADVERSE PATIENT HEALTH CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25212105 ↗
• MalfunctionMay 15, 2026Fluid/Blood Leak

  DURING AN LAAO (LEFT ATRIAL APPENDAGE OCCLUSION) PROCEDURE, AN SWARTZ INTRODUCER WAS USED FOR TRANSSEPTAL PUNCTURE. BLOOD LEAKAGE WAS NOTED AT THE VALVE OF THE SWARTZ INTRODUCER. THE SWARTZ INTRODUCER WAS REPLACED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25191322 ↗
• InjuryMay 15, 2026Adverse Event Without Identified Device or Use Problem

  DURING A PAROXYSMAL ATRIAL FIBRILLATION PROCEDURE, A PERICARDIAL EFFUSION WAS NOTED WHICH RESULTED IN A PERICARDIOCENTESIS. THE TRANSSEPTAL PUNCTURE WAS NOT EASY. AT THE END OF THE PVI, THE PATIENT TENSION WENT FROM 10/7 TO 50/3. THE ECHO WAS CHECKED AND PERICARDIAL EFFUSION WAS NOTED. PROTAMINE WAS INJECTED AND THE EFFUSION WAS DRAINED. 800CC WERE DRAINED AND REINJECTED IMMEDIATELY INTO THE PATIENT. THE TENSION INCREASED TO A NORMAL VALUE TO 11/7 AFTER DRAINAGE. THE PATIENT WENT TO THE ICU AND IS RECOVERING. THE PVI WAS COMPLETED AND SUCCESSFUL. THE PHYSICIAN ALLEGES THAT THE SHEATH DILATOR MAY HAVE CAUSED A MINOR SCRATCH TO THE SEPTUM DURING THE DIFFICULT TRANSSEPTAL PUNCTURE. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICE.

  Patient problems: Cardiac Perforation

  MAUDE report 25185562 ↗
• MalfunctionMay 13, 2026Gas/Air Leak

  DURING THE ATRIAL FIBRILLATION PROCEDURE, AFTER THE INTRODUCER WAS INSERTED INTO THE PATIENT, AIR WAS ASPIRATED. WHILE USING HANDS TO BLOCK THE INTRODUCER HEMOSTASIS VALVE AND PERFORMING ASPIRATION, NO 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 25162715 ↗
• MalfunctionMay 8, 2026Gas/Air Leak

  DURING THE PULMONARY VEIN ISOLATION PROCEDURE, AFTER PUNCTURE AND ACCESS, A LARGE AMOUNT OF AIR WAS ASPIRATED FROM THE VALVE OF THE INTRODUCER. ONLY THE DILATOR WAS INSERTED INTO THE SHEATH. THE INTRODUCER WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT. THE HOSPITAL DISCARDED THE INTRODUCER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25129864 ↗
• MalfunctionMay 5, 2026Gas/Air Leak

  DURING A PROCEDURE, THE SHEATH ASPIRATED AIR. MULTIPLE ASPIRATIONS WERE PERFORMED 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 25086270 ↗
• MalfunctionMay 5, 2026Gas/Air Leak

  DURING AN ATRIAL FIBRILLATION PROCEDURE, AFTER VASCULAR ACCESS WAS OBTAINED, THE GUIDEWIRE AND DILATOR WERE REMOVED, AND AIR ASPIRATION WAS PERFORMED. INTERMITTENT AIR ASPIRATION WAS OBSERVED THROUGH THE HEMOSTASIS VALVE OF THE SHEATH. THE SHEATH WAS REPLACED, AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT. THE HOSPITAL DISCARDED THE REPORTED SHEATH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25083882 ↗
• MalfunctionMay 5, 2026Gas/Air Leak

  DURING AN ATRIAL FIBRILLATION PROCEDURE, AFTER CATHETER INSERTION, CONTINUOUS AIR ASPIRATION WAS OBSERVED DURING AIR ASPIRATION. THE SHEATH WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE HEALTH CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25081492 ↗
• MalfunctionMay 5, 2026Gas/Air Leak

  DURING AN ATRIAL FIBRILLATION PROCEDURE, AFTER INSERTION, AN AIR LEAK WAS NOTED FROM THE HEMOSTASIS VALVE OF THE SHEATH WHEN ASPIRATING. THE SHEATH WAS REPLACED, AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE PATIENT CONSEQUENCES. WHEN HANDS WERE USED TO BLOCK THE HEMOSTASIS VALVE OF THE SHEATH, AIR WAS NOT ASPIRATED, CONFIRMING IT WAS THE VALVE THAT WAS LEAKING AIR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25081434 ↗