Adelante SafeSheath II AS06013B5Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10885672002241), received between Feb 27, 2018 and Apr 3, 2024 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Material Too Rigid or Stiff” (2 reports).

4 other recalls cover devices cleared under the same FDA submission (K122084); 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.

• MalfunctionApr 3, 2024Material Too Rigid or Stiff; Material Too Rigid or Stiff

  IT WAS REPORTED THAT THE SAFE SHEATH HAD AN ISSUE TEARING APART. NO ADVERSE PATIENT SIDE EFFECTS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19037742 ↗
• MalfunctionMar 19, 2024Material Too Rigid or Stiff; Material Too Rigid or Stiff

  THE SAFE SHEATHS WERE USED AND HAD TO BE CUT TO BE SPLIT, THEN DISCARDED AS PER NORMAL HOSPITAL PROCEDURE AS THEY WERE VERY BLOODY. BOTH INTRODUCERS WERE USED IN THE SAME CASE. AS PER THE PER, (B)(6) 2023 AT (B)(6) HOSPITAL. THERE WAS A SLIGHT DELAY, NO MORE THAN AN ADDITIONAL 5 MINUTES TO CUT THE SHEATHS. A DUAL CHAMBER PACEMAKER WAS BEING IMPLANTED, WITH A 52CM 7736 PASSIVE INGEVITY LEAD AND A 59CM 7842 INGEVITY+ LEAD. THE DOCTOR CUT THE SHEATHS USING SCISSORS ALREADY IN THE STERILE FIELD. THE PHYSICIAN USED 2 6F SAFE SHEATHS AND HAD TO CUT BOTH TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18932307 ↗
• MalfunctionJul 27, 2023Material Integrity Problem; Material Integrity Problem

  WHEN USING THE INTRODUCERS, THE HUB FAILED TO CRACK AND SPLIT AWAY FROM THE LEAD IN ONE SINGLE ACTION. THIS RESULTED IN THE IMPLANTER HAVING TO USE SCISSORS TO SPLIT THE REMAINDER OF THE HUB AND THE INTRODUCER FROM OFF THE LEAD. THERE WERE NO IMPACTS ON THE PATIENTS AND THE LEAD/DEVICE IMPLANTS WERE COMPLETED WITHOUT INCIDENT. NO PATIENT SIDE EFFECTS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17402983 ↗
• MalfunctionFeb 27, 2018Air Leak; Leak/Splash; Air Leak; Leak/Splash

  THE COMPLAINT WAS THAT THE INTRODUCERS THEY WERE USING DURING A COUPLE OF IMPLANT CASES APPEARED TO BE LEAKING. HERE IS A SUMMARY FROM THE COMPLAINT: THE PHYSICIAN COMPLAINT THAT THE SHEATHS WE USE SEEM TO BE LEAKING. AFTER GAINING ACCESS AND PUTTING A SHEATH THROUGH THE PUNCTURE SITE, WHEN ATTEMPTING TO FLUSH THE SHEATH, THERE ARE A LOT OF AIR BUBBLES THAT IS ASPIRATED AS HE DRAWS BACK THE SHEATH[?]..AS A RESULT, THERE WAS AIR INTRODUCED INTO THE PATIENT'S VESSELS AS HE ADVANCES THE LEAD INTO THE BODY. HE IS CONCERNED AS THIS PUTS PATIENT AT RISK OF EMBOLISM AND HYPOTENSION. THE FOLLOWING INFORMATION RECEIVED WAS RECEIVED ON FEBRUARY 8, 2018: EVENT DATE: (B)(6) 2017. REPORTED REGION: (B)(6). DID THE EVENT INVOLVE A PATIENT: YES. AGE AND SEX OF PATIENT: MALE (B)(6) YEARS OLD. WHAT IS THE OUTCOME OF THE PATIENT: NO ADVERSE PATIENT EFFECTS WERE REPORTED. NO IMPACT TO THE PATIENT/STABLE: THERE WAS NO REPORTED IMPACT TO THE PATIENT. IF PATIENT IMPACT, PLEASE PROVIDE DETAILS: ANY REPORTED ADVERSE PATIENT EFFECTS: NO ADVERSE PATIENT EFFECTS WERE REPORTED. ANY EXTENDED HOSPITALIZATION: NONE REPORTED. IT WAS REPORTED THE SHEATH WAS LEAKING, HOW WAS THE PRODUCT ISSUE RESOLVED: WAS ANOTHER M

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7301575 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K122084. One submission often covers many models, so check the product and lot details in each record.

• Z-2679-2026 · Jun 10, 2026 · Open, Classified
  Abiomed REF: 0052-3021, Introducer Kit for Impella Hemostatic Peel Away Introducer System with Infusion Sideport, 14F, 23F. heart pump and accessories.
• Z-2678-2026 · Jun 10, 2026 · Open, Classified
  Abiomed REF: 0052-3025, Introducer Kit for Impella Hemostatic Peel Away Introducer System with Infusion Sideport, 14F 13cm and 25cm. heart pump and accessories.
• Z-2680-2026 · Jun 10, 2026 · Open, Classified
  Abiomed REF: 0052-3006, Introducer Kit for Impella Hemostatic Peel Away Introducer System with Infusion Sideport, 23F. heart pump and accessories.
• Z-1467-2021 · Feb 22, 2021 · Terminated
  AngioDynamics Safe Sheath Ultralite - Vascular Introducer/Catheter Introducer Catalogue #: VI10 - Product Usage: For the introduction of various types of pacing leads and catheter