SafeSheath® II SSL9Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 30891492002358), received between May 24, 2023 and Oct 20, 2025 — classified as 1 death, 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryOct 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, THE PHYSICIAN INADVERTENTLY PERFORATED THE LEAD THROUGH THE PATIENT'S HEART. THE PATIENT'S BLOOD PRESSURE DROPPED SIGNIFICANTLY AFTER THE PERFORATION. CARDIOPULMONARY RESUSCITATION WAS PERFORMED, AND A HOSPITAL CODE BLUE' WAS INITIATED. THE PATIENT WAS SENT TO THE OPERATING ROOM FOR STERNOTOMY IN ORDER TO CLOSE THE PERFORATION. THE LEAD WAS NOT IMPLANTED. PROCEDURE ABORTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. PRODUCT NOT RETURNING. MEDTRONIC CUSTOMER REPORTED THERE IS NO COMPLAINT CONCERNING THE OSCOR PRODUCT ON THIS EVENT. NON-COMPLAINT JUSTIFICATION AND RATIONALE: THERE WAS NO ALLEGATION AGAINST THE OSCOR INTRODUCER. THE MDT REP STATED THAT THE RV LEAD HAD PERFORATED THE PATIENT'S HEART TISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. NOT REPORTABLE; INFORMATION/ANALYSIS DOES NOT INDICATE A PRODUCT MALFUNCTION. THERE IS NO INDICATION OF A FAILURE OF THIS MARKETED DEVICE TO MEET CUSTOMER OR USER EXPECTATIONS FOR QUALITY OR TO MEET PERFORMANCE SPECIFICATIONS; THUS, THE ASSOCIATED LINE-ITEM TASKS WILL BE PROCESSED AS A NON-COMPLAINT. (B)(6). (B)(6).

  Patient problems: Cardiac Arrest; Low Blood Pressure/ Hypotension

  MAUDE report 23336413 ↗
• DeathMay 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING AN IMPLANT PROCEDURE THERE WERE DIFFICULTIES IN USING THE FIRST INTRODUCER (13CM) DUE TO PATIENT ANATOMY. A DIFFERENT LONGER INTRODUCER WAS USED (23CM) AND ABLE TO PASS THE SUBCLAVIAN ANGLE. THE IMPLANT PROCEDURE WAS COMPLETED SUCCESSFULLY. AFTER THE IMPLANT THE PATIENT HAD SYMPTOMS AND WAS TAKEN TO CARDIAC SURGERY WHERE A SUBCLAVIAN VEIN LACERATION WAS DISCOVERED. THE LACERATION WAS STITCHED UP. THE PATIENT DIED FOLLOWING THE PROCEDURE. THE DEVICE WAS DISCARDED. PATIENT DEATH WAS ON (B)(6) 2023. OTHER EVENT RELATED TO THE ISSUE REPORTED: 1035166-2023-00047 ADDRESSES THE 13CM INTRODUCER (SAME PATIENT).

  Patient problems: Perforation of Vessels

  MAUDE report 16993443 ↗

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