SafeSheath® II SS8Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 30891492002235), received between Jul 13, 2021 and Apr 28, 2025 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Material Too Rigid or Stiff” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 28, 2025Break; Break

  I WOULD LIKE TO BRING TO YOUR ATTENTION THAT ON (B)(6) 2025 DURING ONE OF OUR EP PROCEDURES, ONE OF YOUR 8 FRENCH SAFE SHEATH II PRODUCTS HAD FRACTURED AND BECAME SEPARATED AT THE WINGTIP HUB AND ITS SHEATH BODY DURING THE SPLITTING PROCESS. THIS FAILURE CAUSED THE SHEATH BODY TO BE LEFT INSIDE THE VESSEL OF THE PATIENT. FORTUNATELY, THE PHYSICIAN WAS ABLE TO EXTRACT THE REMAINING SHEATH FROM THE PATIENT. THIS IS MEANT FOR YOUR AWARENESS AND CURRENTLY REMAINS AN ISOLATED INCIDENT WITH THIS PRODUCT FROM THE LOT NUMBER WE HAVE. INFORMATION PROVIDED IS FROM THE IMPLANTING PHYSICIAN. NO PATIENT INFORMATION PROVIDED. THE PROCEDURE PERFORMED IS A DUAL IMPLANTABLE CARDIOVERTER DEFIBRILLATOR. THE EVENT OCCURRED AT (B)(6) HOSPITAL. THERE WAS NO DELAY IN THE PROCEDURE AND NO MEDICAL OR SURGICAL INTERVENTION PROVIDED. THE PHYSICIAN USED PICKUPS TO PULL REMAINING SHEATH OUT OF PATIENT VESSEL. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. PRODUCT WAS DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21920767 ↗
• MalfunctionJul 27, 2021Material Too Rigid or Stiff; Material Too Rigid or Stiff

  IT WAS REPORTED THE SHEATH DID NOT SPLIT ALL THE WAY DOWN TO THE TIP OF THE SHEATH, INSTEAD THE PEEL ALONG THE LONGITUDINAL AXIS WAS INCOMPLETE. THE SPLIT HAD TO BE COMPLETED BY EITHER CUTTING OR GRASPING THE MATERIAL WITH A CLAMP. NO PATIENT ADVERSE EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12231559 ↗
• MalfunctionJul 27, 2021Material Too Rigid or Stiff; Material Too Rigid or Stiff

  IT WAS REPORTED THE SHEATH DID NOT SPLIT ALL THE WAY DOWN TO THE TIP OF THE SHEATH, INSTEAD THE PEEL ALONG THE LONGITUDINAL AXIS WAS INCOMPLETE. THE SPLIT HAD TO BE COMPLETED BY EITHER CUTTING OR GRASPING THE MATERIAL WITH A CLAMP. NO PATIENT ADVERSE EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12229218 ↗
• MalfunctionJul 19, 2021Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT PLASTIC PIECES OF THE SHEATH BROKE AWAY FROM THE SHEATH BODY. BASED ON ADDITIONAL INFORMATION RECEIVED ON 06/24/2021, THE SAFE SHEATH PLASTIC TIP BROKE OFF FROM THE RUBBER SHEATH WHEN DOCTOR WENT TO TAKE THE SHEATH OFF THE LEAD. THIS HAPPENED MID CASE AFTER ONE LEAD WAS APPEAR THROUGH. THE RUBBER SHEATH WAS EXTRACTED WITHOUT ANY ISSUE. NO ADVERSE PATIENT EVENTS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12188480 ↗
• MalfunctionJul 13, 2021Material Too Rigid or Stiff; Material Too Rigid or Stiff

  IT WAS REPORTED THE SHEATH DID NOT SPLIT ALL THE WAY DOWN TO THE TIP OF THE SHEATH, INSTEAD THE PEEL ALONG THE LONGITUDINAL AXIS WAS INCOMPLETE. THE SPLIT HAD TO BE COMPLETED BY EITHER CUTTING OR GRASPING THE MATERIAL WITH A CLAMP. NO PATIENT ADVERSE EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12160908 ↗

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