Fast-Cath™ 406842Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05414734203364), received between Oct 15, 2019 and Feb 26, 2025 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (2 reports).

4 other recalls cover devices cleared under the same FDA submission (K964518); they may or may not involve this specific model.

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 26, 2025Fluid/Blood Leak; Fluid/Blood Leak

  DURING THE ATRIAL FIBRILLATION PROCEDURE, BLOOD LEAKED FROM THE HEMOSTASIS VALVE WHEN APPLYING NEGATIVE PRESSURE. 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 WAS PERFORMED WHEN THE INTRODUCER WAS REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21472284 ↗
• InjuryNov 4, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURER REPORT NUMBER: 3008452825-2020-00602, 3005334138-2020-00546, 3005334138-2020-00547. FOLLOWING AN AF ABLATION PROCEDURE, THE PATIENT EXPERIENCED A STROKE. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICES. A TRANSESOPHAGEAL ECHO WAS PERFORMED TO EXCLUDE A LEFT ATRIAL APPENDAGE (LAA) THROMBUS, THERE WAS QUESTION OF A THROMBUS IN THE LAA BUT IT WAS DECIDED TO BE UNLIKELY. A TARGET ACT OF 300 OR ABOVE IS MAINTAINED FOR ALL LA ABLATIONS PER THE REPRESENTATIVE. THE PHYSICIAN DID NOT ALLEGE ANY ABBOTT PRODUCT WAS THE CAUSE FOR THE CVA.

  Patient problems: Stroke/CVA

  MAUDE report 10787557 ↗
• MalfunctionOct 15, 2019Fluid/Blood Leak; Fluid/Blood Leak

  DURING AN ATRIAL FIBRILLATION PROCEDURE, BLOOD WAS LEAKING FROM THE SHEATH. THE SHEATH WAS USED TO COMPLETE THE PROCEDURE WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9190965 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K964518. One submission often covers many models, so check the product and lot details in each record.

• Z-0617-2013 · Mar 28, 2012 · Terminated
  Fast-Cath Transseptal Guiding Introducer, 90, 8F, REF 406586, Length 60 cm, Sterile EO, Rx only, St. Jude Medical, 14901 DeVeau Place, Minnetonka, MN 55343 Indicated for introduci
• Z-0535-2007 · Oct 5, 2006 · Terminated
  FastCath Transseptal Catheter Introducers with Hemostasis Valve, DAIG division of St. Jude Medical, Minnetonka, MN, consists of a radiopaque sheath and dilator; Product # 406850.
• Z-1425-04 · Aug 4, 2004 · Terminated
  Telesheath Left Atrial Introducer System Right Superior. Telesheath Catheter Two-Piece Introducer Kit with Hemostasis Valve. Right Superior Reorder #407900. The product is packa
• Z-1426-04 · Aug 4, 2004 · Terminated
  Telesheath Left Atrial Introducer System Right Superior. Telesheath Catheter Two-Piece Introducer Kit with Hemostasis Valve. Left Lateral Reorder #407901. The product is package