Adelante Peel-Away Introducer Set AP07016B5Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10885672100022), received between Feb 13, 2018 and Jun 10, 2024 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Defective Device” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 10, 2024Material Too Rigid or Stiff; Material Too Rigid or Stiff

  SUMMARY: DIFFICULTY IN PEELING AWAY THE SHEATH. THE CUSTOMER REPORTED FOR A NEW PACEMAKER IMPLANTATION, A LEAD WAS INSERTED AFTER THE SHEATH IN QUESTION WAS INSERTED. AFTER THE LEAD REACHED THE RIGHT ATRIUM, AN ATTEMPT WAS MADE TO PEEL THE SHEATH AWAY, BUT THE SHEATH SHAFT PART WAS TORN HALFWAY THROUGH THE ATTEMPT. THE SHEATH WAS THEN REMOVED BY HOLDING THE TORN PART WITH FORCEPS. THE LEAD REMAINED IN THE RIGHT ATRIUM, AND THE PROCEDURE WAS CONTINUED AND COMPLETED WITHOUT ANY PROBLEMS. NO HEALTH DAMAGE WAS REPORTED. THIS EVENT IS NOT REPORTABLE TO PMDA. (B)(6) 2024: THE CUSTOMER STATED THERE WAS NO HARM TO THE PATIENT. PATIENT INFORMATION PROVIDED; INITIAL (B)(6), 72-YEAR-OLD MALE. THERE WAS NO MEDICAL OR SURGICAL INTERVENTION AND NO PROCEDURE DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19505155 ↗
• MalfunctionJan 26, 2023Material Frayed; Material Split, Cut or Torn; Material Frayed; Material Split, Cut or Torn

  DURING IMPLANTATION, BEFORE INSERTING THE SHEATH, IT IS NOTICED THAT THE TIP OF THE INTRODUCER IS FRAYED. NO ADVERSE PATIENT EFFECTS WERE REPORTED. CUSTOMER DID NOT PROVIDE THE EVENT DATE, HOWEVER, ON (B)(6)2023, THEY SUBMITTED THEIR EVENT REPORT FORM. BASED UPON THIS INFORMATION, THIS IS THE DATE WE ARE SUBMITTING AS THE EVENT DATE. SHOULD THE ACTUAL EVENT DATE BE PROVIDED, WE WILL UPDATE OUR REPORT ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16248954 ↗
• MalfunctionJan 13, 2020Defective Device; Defective Device

  THE CUSTOMER REPORTED THE LENGTH OF THE DILATOR WAS FOUND UNUSUALLY SHORT, IT WAS FOUND BEFORE THE DEVICE WAS USED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9581946 ↗
• InjuryFeb 13, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  SUMMARY: THE SHEATH HUB OF ADELANTE AP07016B5 WAS DETACHED FROM THE SHEATH TUBE WHEN A DILATOR AND GUIDEWIRE WERE EXTRACTED. DESCRIPTION / SEQUENCE OF EVENTS: (B)(6) 2016 04:00 P.M. DURING A PACING LEAD IMPLANTATION PROCEDURE, WHEN A DILATOR AND GUIDEWIRE WERE EXTRACTED FROM THE LEFT SUBCLAVIAN VEIN THROUGH THE AP07016B5 IN QUESTION, THE SHEATH HUB ATTACHED TO THE SHEATH TUBE WAS UNEXPECTEDLY DETACHED AND ONLY THE SHEATH TUBE WAS LEFT INSIDE THE VEIN. AS A SLIGHT PART OF THE SHEATH TUBE WAS STICKING OUT FROM THE VEIN, THE SHEATH TUBE WAS SUCCESSFULLY REMOVED FROM THE VEIN USING FORCEPS. ·DURING THE REMOVAL OF THE SHEATH TUBE, A SIGNIFICANT AMOUNT OF BLOOD LEAKED OUT, WHICH DECREASED THE VISIBILITY INSIDE THE DEVICE POCKET.

  Patient problems: Blood Loss

  MAUDE report 7267659 ↗

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.