OneStic Micro-Access Introducer 497847Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00886333224661), received between Mar 15, 2023 and Apr 1, 2025 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Break” (2 reports).

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.

• MalfunctionApr 1, 2025Break; Break

  DURING SURGERY, WHILE USING THE INTRODUCER KIT PLACEMENT, THE FLEXIBLE TIP OF THE WIRE HAS BEEN BROKEN\DETACHED, AND LEFT IN THE VEIN. THE VEIN WAS REMOVED AS A PLANNED PART OF THE SURGERY

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21740816 ↗
• InjuryMar 15, 2023Break; Break

  A PHYSICIAN USED AN INTRODUCER KIT 7F DURING A PROCEDURE. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. THE DEVICE WAS PREPPED PER THE IFU, WITH NO ISSUES IDENTIFIED. THE DOCTOR HAS INDICATED THAT THE GUIDE THAT COMES IN THE INTRODUCER PACK IS VERY FLIMSY, NAVIGATES VERY POORLY. DURING THE PROCEDURE THE GUIDE BROKE AND REMAINED INSIDE, IT COULD BE RESCUED WITHOUT MAJOR PROBLEMS. THIS PACK WITH THIS 0.018" AND 45 CM IN LENGTH GUIDE GENERATES INSECURITY DURING THE PROCEDURE AND THEY DO NOT FEEL COMFORTABLE USING IT. NO PATIENT INJURY REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 16546518 ↗

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