Adelante Peel-Away Introducer Set AP06016B5Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10885672100015), received between Feb 8, 2023 and Sep 22, 2023 — classified as 2 injuries, 2 malfunctions.

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

• InjurySep 22, 2023No Apparent Adverse Event; No Apparent Adverse Event

  DURING DIFFICULT PUNCTION PROCEDURE FROM THE V AXILLARIS, THE SELDINGER WIRE (GERMAN NAME FOR GUIDEWIRE) WOULDN'T PASS THROUGH THE 18-GAUGE NEEDLE. EVENT TOOK PLACE INTRAOPERATIVELY, DURING FIRST IMPLANTATION; THE WIRE CAN'T MOVE BACKWARDS AGAIN, AND COMPLETELY BLOCKED THE LUMEN. CHANGED TO ANOTHER COMPETITOR'S INTRODUCER, THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT ADVERSE EFFECT REPORTED. THE ICD / IPG REMAINS ACTIVE, NO CHANGE. ADDITIONAL INFORMATION RECEIVED ON 29/AUG/2023, THERE WAS A PROCEDURE DELAY FOR APPROXIMATELY 30 MINUTES. SUBMISSION FOR ADMINISTRATIVE PURPOSES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17799799 ↗
• InjuryMar 7, 2023No Apparent Adverse Event; No Apparent Adverse Event

  THE USER HAS SEVERAL COMPLAINTS ABOUT THE OSCOR ADELANTE 6F INTRODUCER KITS AND WISHED TO EXPRESS HER DISSATISFACTION. THE IMPLANTING PHYSICIAN EXPLAINED THAT THESE INTRODUCER KITS ALLOW BLEEDING WHEN THE LEAD IS INSERTED EVEN THOUGH THEY ARE LABELED AS 6F, THEY SEEM TO HAVE A LARGER INNER DIAMETER. FURTHERMORE, THE IMPLANTER FINDS THAT THE INTRODUCERS ARE "STICKY" AND EXPRESSES DIFFICULTY WHEN TRYING TO DOUBLE WIRE WHEN GAINING ACCESS TO THE VEIN. THIS IS ALSO AN ISSUE WHEN THEY TRY TO REPOSITION THE LEAD WHILE IT IS STILL IN THE SHEATH, SHE EXPLAINED THAT IT IS VERY DIFFICULT TO PULL BACK ON THE LEAD AS IT STICKS TO THE INNER LUMEN OF THE SHEATH. FINALLY, WHEN USING PASSIVE LEADS, IF THE LEAD NEEDS TO BE REPOSITIONED AND REMOVED FROM THE PATIENT, SHE IS FINDING THAT THE TINES ARE GETTING STUCK ON THE TIP OF THE INTRODUCER, AND SHE IS NOT ABLE TO PULL IT BACK THROUGH. WHAT THIS MEANS IS THAT SHE IS HAVING TO SPLIT THE SHEATH AND FIND VENOUS ACCESS AGAIN. NOT ONLY IS THIS FRUSTRATING BUT IT LENGTHENS THE CASE WHICH INCREASES THE RISK OF INFECTION, FLUOROSCOPY EXPOSURE AND PNEUMOTHORAX. THE PROCEDURE WAS SUCCESSFUL. PATIENT WAS NOT SUBJECT TO PROCEDURES WHICH MIGHT HAVE DAMAGED THIS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16495466 ↗
• MalfunctionFeb 14, 2023Material Too Rigid or Stiff; Material Too Rigid or Stiff

  THE CLINICIAN REPORTS MORE FRICTION THAN USUAL AS THE LEAD SLIDES INTO THE INTRODUCER. MOREOVER, AT THE TIME OF CUTTING, EVEN IF A LOT OF FORCE IS APPLIED TO THE HANDLES, 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 16375556 ↗
• MalfunctionFeb 8, 2023Break; Material Twisted/Bent; Break; Material Twisted/Bent

  IT WAS REPORTED THAT AFTER REMOVING THE DILATOR FROM THE SHEATH THE SHEATH KINKED AND TORE WHEN PULLED OUT, LEAVING PART OF THE SHEATH IN THE BLOOD VESSEL. WHEN INSERTED, THE SHEATH IS TOO UNSTABLE TO ENTER ANY TARGET VESSEL. REMAINED PART OF THE SHEATH WAS REMOVED FROM THE BLOOD VESSEL WITHOUT ANY PATIENT CONSEQUENCE. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16329184 ↗

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.