Fast-Cath™ 406965Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05414734203159), received between Mar 31, 2022 and Mar 31, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Separation” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 31, 2022Material Separation; Material Separation

  RELATED MANUFACTURING REF: 3008452825-2022-00194. FOLLOWING THE PROCEDURE, AN ATTEMPT WAS MADE TO PULL BACK THE CATHETER WHILE THE SHEATH WAS STILL IN THE INFERIOR VENA CAVA. RESISTANCE WAS NOTED AND IT WAS ADVISED TO PULL THE EQUIPMENT OUT UNDER FLUOROSCOPY. WHEN ATTEMPTING TO PULL THE EQUIPMENT BACK AGAIN, IT WAS NOTED THAT THE CATHETER WAS LOOPED AROUND THE SHEATH AND THE CATHETER HAD SHEARED OFF PART OF THE SHEATH WHEN IT WAS ORIGINALLY PULLED BACK. ALL OF THE SHEATH PIECES OF THE SHEATH WERE RECOVERED WITH NO CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13967889 ↗

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-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
• 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