Swartz™ 407358Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 05414734205535), received between Feb 14, 2020 and Jan 20, 2026 — classified as 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “Flaked” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 20, 2026Fracture

  THIS REPORT IS TO ADVISE OF A FRACTURE FOUND IN THE SHEATH DURING ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24115353 ↗
• MalfunctionDec 12, 2025Material Separation; Material Separation

  DURING AN ATRIAL FIBRILLATION PROCEDURE, AFTER THE CATHETER WAS REMOVED FROM THE PATIENT, IT WAS NOTED THAT THE GRAY TIP OF THE SHEATH WAS MISSING AFTER THE PROCEDURE. IT LOOKED TO BE TORN. 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 23786582 ↗
• MalfunctionDec 2, 2025Material Separation; Material Separation

  DURING THE CAVO-TRICUSPID ISTHMUS PROCEDURE, THE HUB OF THE SHEATH DISCONNECTED. THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23693000 ↗
• InjuryMay 16, 2024Flaked; Difficult to Insert; Flaked; Difficult to Insert

  DURING THE MITRACLIP TAVI/TAVR PROCEDURE, WHILE ADVANCING THE TRANSSEPTAL NEEDLE THROUGH THE SHEATH, RESISTANCE WAS NOTED, REQUIRING AN ADDITIONAL FEMORAL PUNCTURE SITE. 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 19333348 ↗
• MalfunctionJan 31, 2024Flaked; Flaked

  DURING AN ATRIAL FIBRILLATION PROCEDURE, SKIVING OCCURRED. INSERTION DIFFICULTIES WERE NOTED WHILE ADVANCING THE NEEDLE INTO THE SHEATH INTO THE PATIENT. THE SHEATH AND NEEDLE WERE REMOVED AND TESTED ON THE BENCH BY PUSHING AGAINST THE RESISTANCE, THE NEEDLE SHEARED OFF A SECTION OF THE PLASTIC. THE SAME BENCH-TOP TESTING WAS PERFORMED WITH THE SECOND SHEATH AND NEEDLE, AND THE SAME ISSUE WAS NOTED. THE ISSUE WAS EVENTUALLY RESOLVED, AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE PATIENT HEALTH CONSEQUENCES. THERE HAS BEEN NO SUGGESTION THAT ANY PLASTIC WAS DISLODGED IN THE PATIENT'S CIRCULATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18616532 ↗
• MalfunctionJan 29, 2024Fluid/Blood Leak; Fluid/Blood Leak

  DURING A PREMATURE VENTRICULAR CONTRACTION PROCEDURE WITH CARTO, 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 18596907 ↗
• MalfunctionSep 2, 2022Fluid/Blood Leak; Fluid/Blood Leak

  THIS REPORT IT TO ADVISE OF A LEAK IN THE SHEATH DURING ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15348611 ↗
• MalfunctionFeb 14, 2020Flaked; Flaked

  THIS EVENT IS BEING REPORTED BASED ON ANALYSIS REVEALING SKIVING OF THE DILATOR.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9710939 ↗