SafeSheath® Ultra SU7Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 30891492002457), received between Jan 30, 2017 and Feb 15, 2017 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Deformation Due to Compressive Stress” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 15, 2017Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  THE CUSTOMER REPORTED GUIDEWIRE BENT AND STRAYED WIRE NOTED AT TIP.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6332188 ↗
• MalfunctionJan 30, 2017Material Integrity Problem; Material Integrity Problem

  ON (B)(6) 2013 THE CUSTOMER REPORTED "A RPI (RELEASED PRODUCT INVESTIGATION) HAS RECENTLY BEEN ASSIGNED TO ME RELATED TO THE SAFE SHEATH ULTRA INTRODUCER MODEL # SU7. DISTRIBUTOR WAS NOTIFIED ON (B)(6) 2013 OF THE NON-CONFORMANCE. PLEASE REVIEW THE DESCRIPTION AS LISTED IN OUR MDT RPI SYSTEM. IT WAS REPORTED FROM CANADA THAT DURING AN IMPLANT PROCEDURE, IN THE PROCESS OF PEELING THE SAFE SHEATH ULTRA INTRODUCER (MODEL SU7, LOT # DP01510), THE SEAL PARTED BUT ALSO BROKE INTO NUMEROUS LOOSE, SMALL PIECES THAT WERE CLEARED FROM THE STERILE FIELD. THERE WAS CONCERN THAT THE SMALL PIECES OF THE SEAL COULD BE LEFT IN THE POCKET. THE INTRODUCER SHEATH WAS REMOVED AND AN ATTEMPT WAS MADE TO REMOVE THE PARTS FROM THE FIELD. A SECOND USE OF AN INTRODUCER FROM THE SAME LOT PRODUCED THE SAME RESULT. IT WAS ALSO NOTED THAT THERE WERE TWO INSTANCES OF THE SAME PERFORMANCE FROM THIS LOT OF SHEATHS IN SEPARATE CIRCUMSTANCES. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. NO PRODUCTS/PIECES WERE RETURNED TO THE DISTRIBUTOR".

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6285916 ↗

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