Adelante Peel-Away Introducer Set AP08016B5Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10885672100046), received between Feb 21, 2023 and Feb 21, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Too Rigid or Stiff” (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 21, 2023Material Too Rigid or Stiff; Material Too Rigid or Stiff

  THE CLINICIAN REPORTS MORE FRICTION THAN USUAL AS THE LEAD (PLEXA S 65) SLIDES INTO THE INTRODUCER DURING AN IMPLANTATION PROCEDURE. MOREOVER, AT THE TIME OF CUTTING, EVEN IF A LOT OF FORCE IS APPLIED TO THE FINS, THE INTRODUCER IS NOT CUT. IT HAD TO BE CUT WITH SCISSORS TO GET IT OUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16414435 ↗

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.