Adelante SafeSheath Ultra Lite ASUP131318PRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10885672000025), received between Feb 13, 2020 and Feb 13, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).

2 other recalls cover devices cleared under the same FDA submission (K073100); 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.

• MalfunctionFeb 13, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DILATOR HUB DETACHED. DURING THE PROCEDURE PHYSICIAN INSERTED THE SHEATH AND DILATOR OVER A GUIDEWIRE INTO THE IJV. WHEN THEY WERE REMOVING THE GUIDEWIRE AND DILATOR, THE HUB OF THE DILATOR CAME OFF. THEY WERE ABLE TO REMOVE THE DILATOR FROM THE SHEATH AND COMPLETED THE PROCEDURE WITH THE SAME SHEATH IN PLACE. AS PER PHYSICIAN, THE HEAT WELD BETWEEN THE TWO SYSTEMS WEAKENED AND LED TO THE DETACHMENT OF THE HUB. THERE WAS NO PATIENT INJURY REPORTED. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9706661 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K073100. One submission often covers many models, so check the product and lot details in each record.

• Z-0055-2012 · Aug 1, 2011 · Terminated
  8F Safe Sheath Introducer, Catalog number: V18; AngioDynamics, INC. The Valved Introducer sheath is utilized to surgically place the catheter during the port implantation procedu
• Z-0130-2009 · Jul 3, 2008 · Terminated
  Oscor Adelante Luer-Lock Peel Away Introducer Set, for introduction of diagnostic or therapeutic devices into the body.