Swartz™ 407454Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 05414734205788), received between Aug 20, 2018 and Aug 8, 2023 — classified as 4 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Difficult to Insert” (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. 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.

• MalfunctionAug 8, 2023Difficult to Insert; Material Puncture/Hole; Difficult to Insert; Material Puncture/Hole

  DURING AN ATRIAL FIBRILLATION PROCEDURE, A SHEATH PUNCTURE OCCURRED. THE BRK NEEDLE WITH STYLET DID NOT FIT THROUGH THE SL1 SHEATH AND THE NEEDLE PUNCTURED THE SHEATH ON ITS DISTAL SIDE. ANOTHER SHEATH WAS USED TO COMPLETE THE PROCEDURE WITH NO CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17481967 ↗
• MalfunctionApr 5, 2023Flaked; Flaked

  THIS REPORT IS TO ADVISE OF SKIVING FOUND DURING ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16683396 ↗
• InjuryJan 28, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A REDO AF ABLATION PROCEDURE, WHILE PERFORMING THE TRANSSEPTAL PUNCTURE, A PERFORATION OCCURRED. AFTER THE SL1 SHEATH WAS ADVANCED INTO THE POSTERIOR SEPTUM AND INTO THE PERICARDIAL SPACE THE SL1 WAS EXCHANGED WITH AN AGILIS. AFTER THE EXCHANGE, A PERFORATION WAS NOTED VIA ECHOCARDIOGRAM AND A CARDIAC CONSULT WAS CALLED. THE PATIENT REMAINED STABLE AND THE HOLE WAS CLOSED WITH A 14MM AMPLATZER ASD CLOSURE DEVICE, AND THE PROCEDURE WAS NOT COMPLETED. THE PATIENT IS CURRENTLY IN STABLE CONDITION. THERE WAS NO PERFORMANCE ISSUES WITH THE ABBOTT INTRODUCER DEVICE.

  Patient problems: Cardiac Perforation

  MAUDE report 11243004 ↗
• InjuryJun 27, 2020Difficult to Insert; Difficult to Insert

  RELATED MANUFACTURER REFERENCE: 3005334138-2020-00235, 3008452825-2020-00329, 3008452825-2020-00330. DURING A PROCEDURE, RESISTANCE WAS NOTED WHILE TRYING TO ADVANCE THE BRK NEEDLE. FORCE WAS NEEDED TO ADVANCE THE DEVICE. THE SHEATH AND NEEDLE WERE REPLACED, AND AGAIN THE ISSUE WAS NOTED. THE DEVICES WERE REPLACED A THIRD TIME AND RESOLUTION WAS FOUND TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES. NO ADDITIONAL ACCESS SITE WAS REQUIRED, HOWEVER A CLINICALLY SIGNIFICANT DELAY OF 20-30 MINUTES WAS NOTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10204360 ↗
• InjuryJun 27, 2020Difficult to Insert; Difficult to Insert

  RELATED MANUFACTURER REFERENCE: 3005334138-2020-00261, 3008452825-2020-00329, 3008452825-2020-00330. DURING A PROCEDURE, RESISTANCE WAS NOTED WHILE TRYING TO ADVANCE THE BRK NEEDLE. FORCE WAS NEEDED TO ADVANCE THE DEVICE. THE SHEATH AND NEEDLE WERE REPLACED, AND AGAIN THE ISSUE WAS NOTED. THE DEVICES WERE REPLACED A THIRD TIME AND RESOLUTION WAS FOUND TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES. NO ADDITIONAL ACCESS SITE WAS REQUIRED, HOWEVER A CLINICALLY SIGNIFICANT DELAY OF 20-30 MINUTES WAS NOTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10204359 ↗
• InjuryAug 20, 2018Material Separation; Material Separation

  THIS REPORT IS TO ADVISE OF AN EVENT OBSERVED DURING ANALYSIS CONFIRMING SKIVING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7797015 ↗