Axcess Percutaneous Introducer 191745Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00886333206926), received between Aug 3, 2023 and Aug 3, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Fluid/Blood Leak” (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.

• MalfunctionAug 3, 2023Fluid/Blood Leak; Fluid/Blood Leak

  WITHIN THE PAST MONTH I HAVE HAD 2 SHEATHS THAT HAD A LEAK AT PROXIMAL END WHERE THE BIOPTOME IS INSERTED. I WAS STILL ABLE TO COMPLETE THE CASE BUT THROUGHOUT THERE WAS SMALL AMOUNT OF BLOOD LEAKING. I DO NOT RECALL DATE OF FIRST OCCURRENCE BUT SECOND OCCURRENCE WAS ON (B)(6) 2023.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17451389 ↗

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