SafeSheath® II SS11Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 30891492002297), received between Feb 23, 2022 and Feb 23, 2022 — classified as 1 injury.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED WHEN EXPLANTING THE RIGHT VENTRICULAR (RV) LEAD, IN ATTEMPT TO GAIN ACCESS TO PLACE ANOTHER LEAD, A PERFORATION OF THE SUPERIOR VENA CAVA (SVC) OCCURRED. THE PATIENT WAS IMMEDIATELY SENT IN FOR CARDIAC SURGERY, HOWEVER ATTEMPTS TO STABILIZE PATIENT WERE UNSUCCESSFUL AND THE PATIENT DID NOT SURVIVE. ADDITIONAL INFORMATION REPORTED THE PHYSICIAN INDICATED THE PERFORATION WAS LIKELY DUE TO THE INTRODUCER USED TO GAIN VENOUS ACCESS. IT WAS FURTHER REPORTED AS UNKNOWN, AS TO WHETHER THE DILATOR OR SHEATH CAUSED THE PERFORATION. NO REPORTED ISSUE WITH THE DILATOR OR SHEATH. THE DILATOR AND SHEATH WILL NOT BE RETURNED, AS THEY WERE THROWN AWAY AFTER THE CASE. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Great Vessel Perforation

  MAUDE report 13584641 ↗

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-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-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-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