SafeSheath Ultra LiteRecalls & reported problems across all models

We found 3 models of SafeSheath Ultra Lite by Oscor Inc. in the FDA's device registry (GUDID). Together they are named in 24 adverse event reports in the FDA's MAUDE database, received between Oct 5, 2017 and Mar 19, 2025 — classified as 24 malfunctions.

The most frequently reported specific device problem is “Material Too Rigid or Stiff” (17 reports).

1 FDA recall record name at least one of these models by its device identifier.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

SafeSheath Ultra Lite recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Mar 10, 2021Terminated

   Potential for open seal on sterile product

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

Most reported SafeSheath Ultra Lite problems

SafeSheath Ultra Lite models

3 models, most reported first. Each model has its own page with its reports, recalls and device details.

• SafeSheath® Ultra Lite VI10

  INTRODUCER, CATHETER
  1 recall2 reports
• SafeSheath® Ultra Lite VI7

  INTRODUCER, CATHETER
  13 reports
• SafeSheath® Ultra Lite VI85

  INTRODUCER, CATHETER
  9 reports

Recent SafeSheath Ultra Lite adverse event reports

The 15 most recent reports across all models, 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 ↗
• MalfunctionOct 7, 2024Material Too Rigid or Stiff; Material Too Rigid or Stiff

  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. NO SAMPLES WERE RETURNED FOR EVALUATION; CUSTOMER DISCARDED. NO PICTURES WERE PROVIDED. ADDITIONAL COMPLAINT REPORTED: 1035166-2024-00109.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20385174 ↗
• 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 7, 2024Material Too Rigid or Stiff; Material Too Rigid or Stiff

  IT WAS REPORTED THAT THE PEELAWAY 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. NO SAMPLES WERE RETURNED FOR EVALUATION; CUSTOMER DISCARDED. NO PICTURES WERE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20384724 ↗
• 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 9, 2024Material Too Rigid or Stiff; Material Too Rigid or Stiff

  THE CLEAR PLASTIC RING ON THE PEEL AWAY SHEATH ARE NOT BREAKING FREE WITH THE SHEATH. IN TWO CASES THE RING SEPARATED IN PIECES AND BROKE OFF IN THE SHEATH. IN THE THIRD CASE, IT DIDN'T BREAK OPEN LIKE IT SHOULD. THE PROCEDURES WERE COMPLETED WITH THESE DEVICES AND THE PATIENTS DID NOT EXPERIENCE ANY ADVERSE EFFECTS, HARM, OR REQUIRE MEDICAL INTERVENTION AS A RESULT OF THESE INCIDENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19281687 ↗
• 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 30, 2024Material Too Rigid or Stiff; Material Too Rigid or Stiff

  IT WAS REPORTED THAT DURING A PORT PLACEMENT PROCEDURE AN END USER REPORTED AN ISSUE WITH FOUR CT MINI W/VALVED INTRODUCER SMARTPORTS. THE FOLLOWING WAS REPORTED THAT "THE CLEAR PLASTIC RING ON THE PEEL AWAY SHEATH IS NOT BREAKING FREE WITH THE SHEATH. IN TWO CASES THE RING SEPARATED IN PIECES AND BROKE OFF IN THE SHEATH. IN THE THIRD CASE, IT DIDN'T BREAK OPEN LIKE IT SHOULD. ALL 4 CASES WERE MIN PORTS." ULTIMATELY, THE PROCEDURES WERE COMPLETED WITH THESE DEVICES AND THE PATIENTS DID NOT EXPERIENCE ANY ADVERSE EFFECTS, HARM, OR REQUIRE MEDICAL INTERVENTION BECAUSE OF THESE INCIDENTS. PRODUCT DISCARDED. ADDITIONAL COMPLAINTS ASSOCIATED WITH (B)(4) ARE AS FOLLOWS: PR32550 ((B)(4)), PR32551((B)(4)), PR32552 ((B)(4))

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19216976 ↗
• MalfunctionApr 30, 2024Material Too Rigid or Stiff; Material Too Rigid or Stiff

  IT WAS REPORTED THAT DURING A PORT PLACEMENT PROCEDURE AN END USER REPORTED AN ISSUE WITH FOUR CT MINI W/VALVED INTRODUCER SMARTPORTS. THE FOLLOWING WAS REPORTED THAT "THE CLEAR PLASTIC RING ON THE PEEL AWAY SHEATH IS NOT BREAKING FREE WITH THE SHEATH. IN TWO CASES THE RING SEPARATED IN PIECES AND BROKE OFF IN THE SHEATH. IN THE THIRD CASE, IT DIDN'T BREAK OPEN LIKE IT SHOULD. ALL 4 CASES WERE MIN PORTS." ULTIMATELY, THE PROCEDURES WERE COMPLETED WITH THESE DEVICES AND THE PATIENTS DID NOT EXPERIENCE ANY ADVERSE EFFECTS, HARM, OR REQUIRE MEDICAL INTERVENTION AS A RESULT OF THESE INCIDENTS. PRODUCT WAS DISCARDED. ADDITIONAL COMPLAINTS ASSOCIATED WITH COMP-24078 ARE AS FOLLOWS: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19214240 ↗
• 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 ↗
• MalfunctionAug 4, 2022Material Too Rigid or Stiff; Material Too Rigid or Stiff

  A PHYSICIAN REPORTED AN ISSUE WITH A 7F STERILE VALVED INTRODUCER, THAT IS PROVIDED IN THE CT LOW PROFILE SMARTPORT KITS. IT WAS REPORTED THAT THIS PEEL-AWAY SHEATH WOULD NOT CRACK INTO TWO PIECES. ULTIMATELY, THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. THERE WAS NO REPORT OF THE PATIENT EXPERIENCING ANY ADVERSE EFFECTS, HARM, OR REQUIRE MEDICAL INTERVENTION AS A RESULT OF THIS INCIDENT. THE PHYSICIAN REPORTED THAT THIS TYPE OF SHEATH HAS NEVER CRACKED INTO TWO PIECES IN ANY OF THE CASES WHERE IT HAS BEEN USED, NO MATTER HOW VIGOROUSLY IT WAS CRACKED IN ONE DIRECTION, BOTH DIRECTIONS, OR MULTIPLE TIMES. THE PHYSICIAN WAS CONCERNED WITH THE RISK OF RETAINED FOREIGN BODY/CATHETER DISLODGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15165599 ↗

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