Swartz™ 407456Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 05414734205801), received between Dec 15, 2020 and Mar 19, 2021 — classified as 2 injuries, 3 malfunctions.

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

• MalfunctionMar 19, 2021Degraded; Fracture; Degraded; Fracture

  DURING A SUPRAVENTRICULAR TACHYCARDIA PROCEDURE, THE FIRST INTRODUCER BROKE AT THE HUB. A SECOND DEVICE WAS USED, AND THE TIP OF THE SHEATH DETACHED AND REMAINED IN THE PATIENT. WHILE INTRODUCING THE SHEATH AND DILATOR OVER THE LONG 032 GUIDEWIRE INTO THE RIGHT FEMORAL VEIN, THE PROXIMAL PORTION OF THE SHEATH FRACTURED AT THE JUNCTURE OF THE SHAFT AND THE VALVE. THE SHEATH WITH DILATOR WERE THEN REMOVED OVER THE J WIRE TO EXCHANGE FOR A NEW ONE. WHILE REMOVING THE SHEATH, THE DISTAL 1/3 OF IT DETACHED AND REMAINED IN THE SUPERIOR VENA CAVA AT THE LEVEL OF THE RIGHT ATRIUM. A SNARE WAS USED TO RETRIEVE THE DETACHED PORTION AND BRING IT DOWN TO THE LEVEL OF THE RIGHT FEMORAL VEIN. WHILE SNARED, THE SHEATH BEGAN TO BREAK INTO MULTIPLE PIECES AND COULD NOT BE REMOVED PERCUTANEOUSLY. VASCULAR SURGERY WAS NECESSARY TO REMOVE THE PIECES WITH A CUT-DOWN TO THE RIGHT FEMORAL VEIN. INSPECTION OF THE REMAINING, INTACT PORTION OF THE SHEATH REVEALED INNUMEROUS MICRO-FRACTURES THAT TRANSVERSED THE ENTIRETY OF THE SHAFT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11527161 ↗
• InjuryMar 19, 2021Degraded; Material Separation; Degraded; Material Separation

  DURING A SUPRAVENTRICULAR TACHYCARDIA PROCEDURE, THE FIRST INTRODUCER BROKE AT THE HUB. A SECOND DEVICE WAS USED, AND THE TIP OF THE SHEATH DETACHED AND REMAINED IN THE PATIENT. WHILE INTRODUCING THE SHEATH AND DILATOR OVER THE LONG 032 GUIDEWIRE INTO THE RIGHT FEMORAL VEIN, THE PROXIMAL PORTION OF THE SHEATH FRACTURED AT THE JUNCTURE OF THE SHAFT AND THE VALVE. THE SHEATH WITH DILATOR WERE THEN REMOVED OVER THE J WIRE TO EXCHANGE FOR A NEW ONE. WHILE REMOVING THE SHEATH, THE DISTAL 1/3 OF IT DETACHED AND REMAINED IN THE SUPERIOR VENA CAVA AT THE LEVEL OF THE RIGHT ATRIUM. A SNARE WAS USED TO RETRIEVE THE DETACHED PORTION AND BRING IT DOWN TO THE LEVEL OF THE RIGHT FEMORAL VEIN. WHILE SNARED, THE SHEATH BEGAN TO BREAK INTO MULTIPLE PIECES AND COULD NOT BE REMOVED PERCUTANEOUSLY. VASCULAR SURGERY WAS NECESSARY TO REMOVE THE PIECES WITH A CUT-DOWN TO THE RIGHT FEMORAL VEIN. INSPECTION OF THE REMAINING, INTACT PORTION OF THE SHEATH REVEALED INNUMEROUS MICRO-FRACTURES THAT TRANSVERSED THE ENTIRETY OF THE SHAFT.

  Patient problems: Foreign Body Embolism

  MAUDE report 11527144 ↗
• InjuryMar 16, 2021Break; Crack

  PATIENT UNDERGOING PLANNED ABLATION PROCEDURE. DURING SL2 SHEATH ADVANCEMENT INTO RIGHT ATRIUM, THE DISTAL 10CM END OF THE SHEATH WAS FRACTURED. A TOTAL OF THREE PACKAGES OF THIS PRODUCT HAD BEEN OPENED FOR THIS CASE: THE FIRST ONE BROKE AT THE HUB, THE SECOND HAD APPROXIMATELY 10 CM OF THE TIP THAT BROKE OFF IN THE PATIENT (AS NOTED PREVIOUSLY) AND THE THIRD WAS NOTED TO HAVE CRACKING AND WAS NOT USED. THE BROKEN CATHETER TIP AND SHEATH IN THE PATIENT REQUIRED A SURGICAL CUT-DOWN BY VASCULAR SURGERY TO REMOVE ALL THE PIECES. FDA SAFETY REPORT ID# (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 11506589 ↗
• MalfunctionDec 15, 2020Fracture; Fracture

  DURING THE PROCEDURE, THE TIP AND CENTER OF THE INTRODUCERS WERE FRACTURED. THE FRACTURES WERE SEGMENTED ALONG THE INTRODUCER SHAFT, AND THE MATERIAL WAS BEING HELD TOGETHER BY THE BRAIDED MATERIAL. THE INTRODUCERS WERE REPLACED, AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL ACCESS SITE WAS REQUIRED DURING REPLACEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11013872 ↗
• MalfunctionDec 15, 2020Fracture; Fracture

  RELATED MANUFACTURING REF: 3005334138-2020-00630. DURING THE PROCEDURE, THE TIP AND CENTER OF THE INTRODUCERS WERE FRACTURED. THE FRACTURES WERE SEGMENTED ALONG THE INTRODUCER SHAFT AND THE MATERIAL WAS BEING HELD TOGETHER BY THE BRAIDED MATERIAL. THE INTRODUCERS WERE REPLACED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL ACCESS SITE WAS REQUIRED DURING REPLACEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11013688 ↗