Fast-Cath™ 407436Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05414734203647), received between Jan 15, 2025 and Sep 24, 2026 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Material Puncture/Hole” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjurySep 24, 2026Material Puncture/Hole

  During the PFO procedure, a femoral vein dissection was noted during transseptal puncture after a puncture of the Fast-Cath sheath. Under fluoro it was noted that the needle was observed passing through the wall of the Fast-Cath introducer. The BRK needle and the Fast-Cath sheath were removed from the patient. It was noted that the patient experienced a femoral vein dissection without any other complication. There were no interventions performed and the patient remained stable.

  Patient problems: Vascular Dissection

  MAUDE report 50883396 ↗
• MalfunctionJan 15, 2025Material Puncture/Hole; Material Puncture/Hole

  DURING AN ATRIAL FIBRILLATION PROCEDURE, THE NEEDLE PUNCTURED THE SHEATH. WHEN ADVANCING THE NEEDLE THROUGH THE DILATOR, THE NEEDLE DID ADVANCE THROUGH THE TIP. THE NEEDLE WAS PULLED BACK, AND THEN THE SHEATH AND DILATOR WERE REMOVED FROM THE PATIENT. IT WAS NOTED THAT THE NEEDLE HAD PUNCTURED THROUGH THE DILATOR WITH NO CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21160747 ↗

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