Catheter Introducer Kit 6F 497792*Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00886333214976), received between Mar 24, 2022 and Mar 24, 2022 — classified as 2 malfunctions.

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

• MalfunctionMar 24, 2022Loose or Intermittent Connection

  BLUE TWISTING "LOCK" ON STERILE SLEEVE OF INTRODUCER WAS MISSING ON 2 DEVICES AND FAILED TO SECURELY LOCK ON A THIRD. THIS INTRODUCER IS USED TO PLACE TEMPORARY TRANSVENOUS PACEMAKER WIRES AND WHEN IT DOES NOT LOCK SECURELY, THE LIKELIHOOD OF THE WIRE MOVING OUT OF PLACE IS HIGHER. THE CHANCES OF THE STERILE SLEEVE SLIPPING TO EXPOSE THE CATHETER SO THAT IT'S NO LONGER STERILE ALONG ITS EXTERNAL LENGTH IS ALSO HIGHER. THIS MEANS THAT THE WIRE CANNOT SAFELY BE ADVANCED IF NEEDED. THIS HAS HAPPENED WITH 3 DIFFERENT KITS - 1 FOR A PATIENT WHOSE WIRE WAS PLACED IN ER, 2 WHOSE WIRES WERE PLACED IN CCU. STERILE SLEEVE WAS EXTENDED AND SECURELY TAPED TO THE PACING CATHETER AND THE DEVICE WAS EXTENSIVELY SECURED INTO PLACE WITH TAPE. ISSUE WAS DISCOVERED AFTER PLACEMENT AND REMAINED IN PATIENTS UNTIL PLACEMENT OF PERMANENT PACEMAKER AT (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13889387 ↗
• MalfunctionMar 24, 2022Product Quality Problem; Component Missing; Incomplete or Inadequate Connection

  BLUE TWISTING "LOCK" ON STERILE SLEEVE OF INTRODUCER WAS MISSING ON 2 DEVICES AND FAILED TO SECURELY LOCK ON A THIRD. THIS INTRODUCER IS USED TO PLACE TEMPORARY TRANSVENOUS PACEMAKER WIRES AND WHEN IT DOES NOT LOCK SECURELY, THE LIKELIHOOD OF THE WIRE MOVING OUT OF PLACE IS HIGHER. THE CHANCES OF THE STERILE SLEEVE SLIPPING TO EXPOSE THE CATHETER SO THAT IT'S NO LONGER STERILE ALONG ITS EXTERNAL LENGTH IS ALSO HIGHER. THIS MEANS THAT THE WIRE CANNOT SAFELY BE ADVANCED IF NEEDED. THIS HAS HAPPENED WITH 3 DIFFERENT KITS - 1 FOR A PATIENT WHOSE WIRE WAS PLACED IN ER, 2 WHOSE WIRES WERE PLACED IN (B)(6). STERILE SLEEVE WAS EXTENDED AND SECURELY TAPED TO THE PACING CATHETER AND THE DEVICE WAS EXTENSIVELY SECURED INTO PLACE WITH TAPE. ISSUE WAS DISCOVERED AFTER PLACEMENT AND REMAINED IN PATIENTS UNTIL PLACEMENT OF PERMANENT PACEMAKER AT (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13888946 ↗

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