SafeSheath® Ultra Lite VI10Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 25051684026298), received between Mar 2, 2021 and Mar 19, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

1 FDA recall record name this device's identifier.

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.

Recalls naming this device

1. Mar 10, 2021Class IITerminated

   Potential for open seal on sterile product

   Z-1329-2021 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 19, 2025Break; Break

  AN END USER REPORTED HAVING AN ISSUE WITH THE INTRODUCER DURING A PROCEDURE. AFTER THE PEEL AWAY DILATOR WAS INSERTED AND UPON REMOVAL THE HUB SEPARATED FROM THE DILATOR, LEAVING IT RETAINED INSIDE THE PEEL AWAY. THIS WAS IMMEDIATELY NOTED BY THE SCRUB TECH, WHO THEN ALERTED THE PHYSICIAN, AND THE FRAGMENTED DEVICE WAS REMOVED, WITHOUT INCIDENT. THE FOLLOWING PROCEDURE WAS COMPLETED WITH ANOTHER SAME DEVICE. (B)(6) /2025, THE ISSUE WAS FOUND DURING A RIGHT HEART CATHETERIZATION AND PORT IMPLANT PROCEDURE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS, HARM, OR REQUIRE MEDICAL INTERVENTION BECAUSE OF THIS INCIDENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING ANOTHER DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21641682 ↗
• MalfunctionMar 2, 2021Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED THAT DURING THE DISTRIBUTOR'S RECEIVING INSPECTION SEVERAL SAMPLES OF LOT DP-11759 WAS FOUND TO HAVE A PREMATURE STERILE BREACH. THERE WAS NO PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11398033 ↗

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.