One Piece/Tuohy-Borst Catheter Introducer 496132Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00886333213597), received between May 20, 2020 and May 20, 2020 — classified as 1 malfunction.

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

5 other recalls cover devices cleared under the same FDA submission (K780126); 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 18, 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.

• MalfunctionMay 20, 2020Break

  THE STEP OF PROCEDURE: 1.INSERT NEEDLE TO THE FEMORAL VEIN , 2.INSERT GUIDEWIRE, 3.REMOVE NEEDLE, 4.INSERT SHEATH, 5.REMOVE GUIDEWIRE AND DILATOR, 6.THE DR. HOLD THE BODY OF SHEATH (NEAR VALVE) PREPARE TO INSERT TUBING, BUT HE FOUND THE SHEATH WAS BROKEN AND THE BROKEN PARTS WAS SHIFTED NEAR TO RIGHT ATRIUM. IT WAS TAKEN OUT BY SNARE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10075707 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K780126. One submission often covers many models, so check the product and lot details in each record.

• Z-2705-2026 · Jun 1, 2026 · Open, Classified
  One-Piece Introducer Tray, REF: 497455, 497434 cardiovascular
• Z-2806-2020 · Jun 19, 2020 · Terminated
  ClosureFast Micro Introducer Sheath Set, REF MIS-7F11; 7Fr/Ch (2.3mm)x11 cm. STERILE|EO; Rx ONLY - Product Usage: Introducer Products are stand-alone components, standard kits, or
• Z-1938-2020 · Apr 8, 2020 · Terminated
  PAC Tray/5 Catheter Introducer Tray 8F, Model 497424, Rx Only, STERILE EO, UDI: 00886333214440 - Product Usage: The introducers are indicated for use in arterial and venous procedu
• Z-1029-2016 · Feb 17, 2016 · Terminated
  ClosureFast Micro Introducer Sheath Set 7Fr/Ch(2.3mm) x 7 cm REF MIS-F707 and ClosureFast Introducer Sheath Set 7Fr/Ch(2.3mm) x 11 cm REF IS-7F11. Indicated for use in arterial and
• Z-0764-2010 · Jan 6, 2009 · Terminated
  Percutaneous Catheter Introducer Set, VNUS Medical Technologies Cath Shth Intro 7F x 7cm, catalog number IS-7F07, Disposable, Single Use, Do Not Re-sterilize, Manufactured in USA f