SafeSheath® Ultra Lite VI85Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 25051684026281), received between Mar 3, 2020 and Oct 7, 2024 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Material Too Rigid or Stiff” (8 reports).

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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 7, 2024Material Too Rigid or Stiff; Material Too Rigid or Stiff

  (B)(4) - AN END USER REPORTED AN ISSUE WITH TWO CT W/8FR DETACHED POLY CATH W/VI SMARTPORTS. IT WAS REPORTED THAT THE PEEL AWAY SHEATH DOES NOT SNAP APART, REQUIRING THE END USER TO CUT THE PLASTIC CENTER PIECE IN ORDER TO USE THE SHEATH. THERE WAS NO REPORT OF PATIENT HARM OR ADVERSE EVENT BY THE END USER. THE CUSTOMER REPORTED TWO OCCURRENCES OF THIS ISSUE FOR THE SPECIFIED LOT NUMBER. DEVICE IS EXPECTED TO RETURN FOR EVALUATION. ADDITIONAL COMPLAINT REPORTED: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20384864 ↗
• MalfunctionOct 3, 2024Material Too Rigid or Stiff; Material Too Rigid or Stiff

  THE CUSTOMER REPORTED THAT THE PROCEDURE WAS A PORT PLACEMENT. THE EVENT OCCURRED DURING PREPARATION. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20359252 ↗
• MalfunctionMay 2, 2024Material Too Rigid or Stiff; Material Too Rigid or Stiff

  IT WAS REPORTED THAT THE PEELAWAY MECHANISM DID NOT WORK WELL AND THE PHYSICIAN HAD TO RELY ON USING A HEMOSTAT TO TEAR AWAY THE SHEATH, FROM THE CATHETER. THE PROCEDURE WAS COMPLETED AND THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS, HARM, OR REQUIRE MEDICAL INTERVENTION AS A RESULT OF THIS INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19234662 ↗
• MalfunctionApr 29, 2024Material Too Rigid or Stiff; Material Too Rigid or Stiff

  END USER REPORTED AN ISSUE WITH THE SHEATH IN A CT W/8FR DETACHED POLY CATH W/VI SMARTPORT KIT. DURING PROCEDURE IT WAS REPORTED THAT THE PEEL AWAY MECHANISM DID NOT WORK WELL, AND THE PHYSICIAN HAD TO RELY ON USING A HEMOSTAT TO TEAR AWAY THE SHEATH, FROM THE CATHETER. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THIS DEVICE, AND THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS, HARM, OR REQUIRE MEDICAL INTERVENTION AS A RESULT OF THIS INCIDENT. DEVICE WILL NOT BE RETURNED FOR EVALUATION, AS IT WAS DISPOSED OF. NO SAMPLE OR PHOTO WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19209870 ↗
• MalfunctionApr 29, 2024Material Too Rigid or Stiff; Material Too Rigid or Stiff

  EVENT DATE AND PROCEDURE DATES ARE BOTH (B)(6) 2024; EVENT OCCURRED IN THE USA AND NO PATIENT INFORMATION WAS PROVIDED. THE DEVICE WAS USED FOR TREATMENT; PROBLEM WAS NOTICED DURING A PORT PLACEMENT PROCEDURE. END USER REPORTED AN ISSUE WITH THE SHEATH IN A CT W/8FR DETACHED POLY CATH W/VI SMARTPORT KIT. IT WAS REPORTED THAT THE PEEL AWAY MECHANISM DID NOT WORK WELL, AND THE PHYSICIAN HAD TO RELY ON USING A HEMOSTAT TO TEAR AWAY THE SHEATH, FROM THE CATHETER. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THIS DEVICE, AND THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS, HARM, OR REQUIRE MEDICAL INTERVENTION. DEVICE WILL NOT BE RETURNED FOR EVALUATION, AS IT WAS DISPOSED OF. THERE ARE TWO LOT NUMBERS THAT WENT INTO THE ONE UPN KIT; IT WAS REPORTED THAT NEITHER LOT NUMBER COULD BE CONFIRMED AS TO WHICH LOT NUMBER WAS INVOLVED IN THIS INCIDENT (DP-18917 OR DP-18918).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19204702 ↗
• MalfunctionApr 24, 2024Material Too Rigid or Stiff; Material Too Rigid or Stiff

  AN END USER REPORTED AN ISSUE WITH THE SHEATH IN A CT W/8FR DETACHED POLY CATH W/VI SMARTPORT KIT. IT WAS REPORTED THAT THE PEEL AWAY MECHANISM DID NOT WORK WELL AND THE PHYSICIAN HAD TO RELY ON USING A HEMOSTAT TO TEAR AWAY THE SHEATH, FROM THE CATHETER. THE PROCEDURE WAS COMPLETED, AND THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS, HARM, OR REQUIRE MEDICAL INTERVENTION AS A RESULT OF THIS INCIDENT. FOR (B)(4) ONLY DP-18917 WAS THE REPORTED LOT. ADDITIONAL COMPLAINTS ASSOCIATED WITH (B)(4) ARE AS FOLLOWS: (B)(4). EVENTS: EVENT DATE: LOT NUMBERS: (B)(4). 03/13/2024 DP-18917 & DP-18918. (B)(4). 03/15/2024 DP-18917 & DP-18918. (B)(4). 03/18/2024 DP-18917 & DP-18918. (B)(4). 03/19/2024 DP-18917.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19174431 ↗
• MalfunctionApr 23, 2024Material Too Rigid or Stiff; Material Too Rigid or Stiff

  AN END USER REPORTED AN ISSUE WITH THE SHEATH IN A CT W/8FR DETACHED POLY CATH W/VI SMARTPORT KIT. IT WAS REPORTED THAT THE PEEL AWAY MECHANISM DID NOT WORK WELL AND THE PHYSICIAN HAD TO RELY ON USING A HEMOSTAT TO TEAR AWAY THE SHEATH, FROM THE CATHETER. THE PROCEDURE WAS COMPLETED, AND THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS, HARM, OR REQUIRE MEDICAL INTERVENTION BECAUSE OF THIS INCIDENT. THESE COMPLAINTS ARE FROM THE SAME CUSTOMER AS (B)(6) BUT NO SAMPLES OR PHOTOS WERE PROVIDED. PRODUCT DISPOSED. ADDITIONAL COMPLAINTS ASSOCIATED WITH COMP (B)(4) ARE AS FOLLOWS: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19166718 ↗
• MalfunctionApr 23, 2024Material Too Rigid or Stiff; Material Too Rigid or Stiff

  AN END USER REPORTED AN ISSUE WITH THE SHEATH IN A CT W/8FR DETACHED POLY CATH W/VI SMARTPORT KIT. IT WAS REPORTED THAT THE PEEL AWAY MECHANISM DID NOT WORK WELL AND THE PHYSICIAN HAD TO RELY ON USING A HEMOSTAT TO TEAR AWAY THE SHEATH, FROM THE CATHETER. THE PROCEDURE WAS COMPLETED, AND THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS, HARM, OR REQUIRE MEDICAL INTERVENTION AS A RESULT OF THIS INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19163457 ↗
• MalfunctionMar 3, 2020Leak/Splash; Leak/Splash

  THE CUSTOMER REPORTED THEY WERE USING THE VALVED INTRODUCER AND IT WASN'T CLOSING, ALLOWING FOR BLOOD TO COME OUT. NO SAMPLE OR PHOTO WAS PROVIDED. THE EVENT OCCURRED DURING TREATMENT (ARM PORT) PROCEDURE WAS COMPLETED WITH THIS DEVICE. NO PATIENT IMPACT, OR PATIENT COMPLICATION WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9782287 ↗

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.