SafeSheath® II 667462-300Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 20802526532485), received between May 17, 2021 and Oct 13, 2021 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Break” (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.

• MalfunctionOct 13, 2021Break; Crack; Break; Crack

  IT WAS REPORTED THAT WHEN PEELING THE SHEATH CRACK WAS NOTICED. THE SHEATH WAS CUT OPEN WITH SMALL SHARP SCISSORS AFTER IT WAS TORN OFF DURING PEELING. THE DEVICE ISSUE RESOLVED BY CAREFULLY CUTTING THE SHEATH. THERE WAS NO SURGICAL DELAY REPORTED. THERE WAS NO PATIENT SIDE EFFECTS REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12623158 ↗
• MalfunctionJul 27, 2021Material Too Rigid or Stiff; Material Too Rigid or Stiff

  IT WAS REPORTED THAT A SAFESHEATH INTRODUCER BROKE RIGHT AT THE HUB INSTEAD OF PEELING AWAY AS DESIGNED, A CUTTER WAS USED TO REMOVE THE INTRODUCER OUT OF THE PATIENT - NO ISSUE FOR PATIENT, BUT WAS DIFFICULT TO GET OUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12226526 ↗
• InjuryJul 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING AN ATTEMPTED CASE FOR A CRTD PROCEDURE A (B)(6) FEMALE PATIENT WAS FOUND TO HAVE POOR ANATOMY; NO LEADS WERE IMPLANTED BUT TWO SAFESHEATHS 8F 13CM THEN 9F 23 AND WIRES WERE ATTEMPTED; CONCERNED ABOUT SUPERIOR VENAE CAVA (SVC) TEAR DUE EITHER TO POSSIBLE SAFESHEATH OR GUIDEWIRE. PATIENT TAKEN TO OR FOR POSSIBLE TEAR/REPAIR.

  Patient problems: Great Vessel Perforation

  MAUDE report 12173290 ↗
• MalfunctionMay 17, 2021Break; Break

  IT WAS REPORTED DURING LEAD INSERTION IN A ICD PLACEMENT PHYSICIAN ATTEMPTED TO REMOVE THE SHEATH AND THE ON SIDE TORE OFF HALFWAY WHILE STILL IN THE PATIENT. PHYSICIAN HAD DIFFICULTY IN REMOVING REMAINDER OF THE SHEATH. THE EVENT DID NOT INVOLVE MEDICATION OR OTHER SUBSTANCE. NO HARM WAS CAUSED TO PATIENT. NO ADDITIONAL INFORMATION IS AVAILABLE. NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11837613 ↗

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-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-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-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