SafeSheath® Ultra SU9Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 30891492002471), received between Feb 3, 2017 and Feb 3, 2017 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Backflow” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 3, 2017Backflow; Backflow

  THE CUSTOMER REPORTED THE INTRODUCER/DILATOR WAS INSERTED INTO AXILLARY VEIN OVER THE INCLUDED GUIDEWIRE IN STANDARD FASHION. THE DILATOR WAS THEN REMOVED WHILE KEEPING THE GUIDEWIRE IN PLACE. THERE WAS SIGNIFICANT BLEED-BACK THROUGH THE HOMEOSTATIC VALVE (PATIENT WITH ELEVATED PULMONARY/VENOUS PRESSURE) WITH ONLY THE GUIDEWIRE IN PLACE THROUGH THE HOMEOSTATIC VALVE. PHYSICIAN FELT THE BLEED-BACK VIA THE HOMEOSTATIC VALVE WAS EXCESSIVE AND POSSIBLY DEFECTIVE. ONE OF THE INTRODUCERS WAS RETURNED AND ONE WAS DISPOSED OF IN THE FIELD. THE VISUAL ANALYSIS DIDN'T FIND ANY ANOMALIES ON THE RETURNED INTRODUCER, HOWEVER THE RETURNED PRODUCT ANALYSIS LAB DOESN'T PERFORM LEAK TESTING ON INTRODUCERS. ADDITIONAL PRODUCT EVENT DETAILS TWO DIFFERENT LOT NUMBER SU9 INTRODUCERS WERE INITIALLY OPENED FOR THE PROCEDURE, SO IT IS UNKNOWN WHICH IS THE AFFECTED LOT. THOUGH, THE INTRODUCER WITH THE ABOVE DESCRIBED PROBLEM WAS REMOVED FROM THE BODY INTACT AND PLACED IN A RETURNED PRODUCT BAG. THE AFFECTED INTRODUCER WAS REPLACED WITH ANOTHER MODEL SU9 INTRODUCER. THE CUSTOMER REPORTED THAT THEY DID NOT RECEIVE THIS DEVICE FOR ANALYSIS.

  Patient problems: Blood Loss

  MAUDE report 6301804 ↗
• MalfunctionFeb 3, 2017Backflow; Backflow

  THE CUSTOMER REPORTED THE INTRODUCER/DILATOR WAS INSERTED INTO AXILLARY VEIN OVER THE INCLUDED GUIDEWIRE IN STANDARD FASHION. THE DILATOR WAS THEN REMOVED WHILE KEEPING THE GUIDEWIRE IN PLACE. THERE WAS SIGNIFICANT BLEED-BACK THROUGH THE HOMEOSTATIC VALVE (PATIENT WITH ELEVATED PULMONARY/VENOUS PRESSURE) WITH ONLY THE GUIDEWIRE IN PLACE THROUGH THE HOMEOSTATIC VALVE. PHYSICIAN FELT THE BLEED-BACK VIA THE HOMEOSTATIC VALVE WAS EXCESSIVE AND POSSIBLY DEFECTIVE. ONE OF THE INTRODUCERS WAS RETURNED AND ONE WAS DISPOSED OF IN THE FIELD. THE VISUAL ANALYSIS DIDN'T FIND ANY ANOMALIES ON THE RETURNED INTRODUCER, HOWEVER THE RETURNED PRODUCT ANALYSIS LAB DOESN'T PERFORM LEAK TESTING ON INTRODUCERS. ADDITIONAL PRODUCT EVENT DETAILS: TWO DIFFERENT LOT NUMBER SU9 INTRODUCERS WERE INITIALLY OPENED FOR THE PROCEDURE, SO IT IS UNKNOWN WHICH IS THE AFFECTED LOT. THOUGH, THE INTRODUCER WITH THE ABOVE DESCRIBED PROBLEM WAS REMOVED FROM THE BODY INTACT AND PLACED IN A RETURNED PRODUCT BAG. THE AFFECTED INTRODUCER WAS REPLACED WITH ANOTHER MODEL SU9 INTRODUCER LOT NUMBER DP02107.

  Patient problems: Blood Loss

  MAUDE report 6299660 ↗

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