SafeSheath® II SS95Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 30891492002266), received between Jul 18, 2022 and Oct 3, 2024 — classified as 3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 3, 2024Break; Break

  IT WAS REPORTED THAT DURING USE OF THIS INTRODUCER DURING A LEAD IMPLANT PROCEDURE, WHILE SPLITTING THE SHEATH, IT WAS REPORTED THAT THE HUB CAME AWAY FROM THE BODY OF THE SHEATH AND LEFT HALF OF THE HUB IN THE PHYSICIAN'S HAND. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE CUSTOMER STATED THE PRODUCT HAS BEEN RECEIVED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20360108 ↗
• MalfunctionJul 18, 2022Material Too Rigid or Stiff; Material Too Rigid or Stiff

  IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE THE SHEATH DID NOT TEAR AWAY FROM THE PACING LEAD HAD BE TO CUT AWAY FROM THE LEAD. THE SHEATH WAS SAFELY REMOVED FROM THE LEAD. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15047717 ↗
• MalfunctionJul 18, 2022Material Too Rigid or Stiff; Material Too Rigid or Stiff

  IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE THE SHEATH DID NOT TEAR AWAY FROM THE PACING LEAD HAD BE TO CUT AWAY FROM THE LEAD. THE SHEATH WAS SAFELY REMOVED FROM THE LEAD. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15047447 ↗

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