SafeSheath® Ultra Lite VI7Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 25051684026267), received between Oct 5, 2017 and Oct 7, 2024 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Material Too Rigid or Stiff” (9 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• 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

  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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• MalfunctionJul 26, 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 IS CONCERNED WITH THE RISK OF RETAINED FOREIGN BODY/CATHETER DISLODGEMENT. THE DEVICE WAS USED IN TREATMENT. THE DEVICE WAS DISPOSED BY THE CUSTOMER (HOSPITAL, PHYSICIAN). NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15103746 ↗
• MalfunctionJul 21, 2022Break; Material Too Rigid or Stiff; Break; 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 IS CONCERNED WITH THE RISK OF RETAINED FOREIGN BODY/CATHETER DISLODGEMENT. THE DEVICE WAS USED FOR TREATMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15073803 ↗
• MalfunctionJun 10, 2021Material Too Rigid or Stiff; Material Too Rigid or Stiff

  A NURSE REPORTED AN ISSUE WITH A 7F STERILE VALVED INTRODUCER FROM A SMARTPORT PROCEDURE KIT. DURING A PROCEDURE, THE DOCTOR WAS PLACING THE PORT AND THE SHEATH DID NOT PEEL LIKE IT WAS SUPPOSED TO. ONE SIDE (WING) BROKE OFF WHEN THE DOCTOR ATTEMPTED TO PEEL IT; THEREFORE, THE DOCTOR HAD TO GRAB IT WITH FORCEPS AND RIP IT APART TO REMOVE IT. THE PROCEDURE WAS COMPLETED WITH THIS KIT / DEVICE. THERE WAS NO PATIENT HARM OR INJURY DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11979017 ↗
• MalfunctionJun 2, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  DURING THE PROCEDURE, THE SHEATH BROKE INTO PIECES WHEN THE CATHETER WAS ADVANCED THROUGH THE SHEATH. THE WING OF THE SHEATH REMAINED INTACT AND THE ORANGE AND CLEAR PART OF THE INTRODUCER BROKE INTO 2 TO 4 PIECES. THIS REQUIRED THE PHYSICIAN TO CAREFULLY REMOVE ALL THE PIECES TO ENSURE NONE ARE LEFT INSIDE OF THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE MEDICAL INTERVENTION. PROCEDURE WAS COMPLETED WITH ANOTHER INTRODUCER. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11924302 ↗
• MalfunctionNov 20, 2019Break; Break

  CUSTOMER STATES THE PRODUCT DID NOT PEEL AWAY AS INDICATED, RESULTING IN THE SURGEON HAVING TO MANIPULATE AND PRY IT WITH INSTRUMENTS. WHICH RESULTED IN THE PORT CATHETER TO DISLODGE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9348432 ↗
• MalfunctionNov 19, 2019Break; Break

  THE CUSTOMER STATES THAT THE PRODUCT DID NOT PEEL AWAY AS INDICATED. IT WAS SPLITTING. RESULTED IN SURGEONS HAVING TO MANIPULATE AND PRY WITH INSTRUMENTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9344128 ↗
• MalfunctionOct 5, 2017Break; Break

  CUSTOMER REPORTED WHEN PHYSICIAN WAS TRYING TO PEEL THE SAFE SHEATH, THE HAND PIECE BROKE. REQUEST FOR ADDITIONAL INFORMATION APRIL 12, 2016. IN ORDER TO DETERMINE REPORTABILITY FOR THIS COMPLAINT, ADDITIONAL INFORMATION IS NEEDED: CUSTOMER REPORTED WHEN PHYSICIAN WAS TRYING TO PEEL THE SAFE SHEATH, THE HAND PIECE BROKE. SAFESHEATH ULTRA LITE, LOT # DP-03782. · DID THIS BREAKAGE OCCURRED AT THE END OF THE PROCEDURE? UNKNOWN. · WHAT PROCEDURE WAS BEING PERFORMED? PORT PLACEMENT. · WAS THE SURGEON ABLE TO REMOVE THE REST OF THE SHEATH FROM THE PATIENT'S VESSEL? YES. · HOW DID THE SURGEON REMOVE THE SHEATH FROM THE PATIENT? UNKNOWN. · WAS THERE ANY PATIENT INJURY? NONE NOTED. · WHAT COUNTRY DID THIS EVENT TAKE PLACE? USA. · WHAT IS THE AGE AND SEX OF THE PATIENT? UNKNOWN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6915391 ↗

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.