SafeSheath® II SSCL9Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10885672009899), received between Mar 28, 2024 and Mar 27, 2025 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryMar 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A POST OPERATIVE CHECK ON THE DAY OF IMPLANT THE PATIENT REPORTED FEELING SOME PAIN THEIR UPPER LEFT CHEST. A CHEST X-RAY WAS PERFORMED AND THE PHYSICIAN SUSPECTED THAT THE DISTAL END OF THE EXTRAVASCULAR (EV) LEAD MAY HAVE ENTERED THE LEFT PLEURA. FIVE DAYS LATER SOME DEVICE SITE PAIN WAS STILL PRESENT, BUT THE "LUNG PAIN" HAD EASED. THE PATIENT WILL CONTINUE TO BE MONITORED, AND THE EV LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. 27/MAR/2025 THERE WAS NO DEVICE PERFORMANCE FAILURE REPORTED BY THE USER, FOR THE SSCL9. THE DEVICE WILL NOT BE RETURNED AS IT WAS DISCARDED. SUBMISSION FOR ADMINISTRATIVE PURPOSES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21709944 ↗
• MalfunctionMar 19, 2025Break; Break

  IT WAS REPORTED THAT DURING IMPLANT, THE LUER HUB WAS DETACHED FROM THE INTRODUCER SHEATH AND THE VALVE END REMAINED AFTER PEELING AWAY. THE INTRODUCER WAS REMOVED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. CUSTOMER DISCARDED DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21643898 ↗
• InjuryMar 28, 2024Fluid/Blood Leak; Fluid/Blood Leak

  ADDITIONAL INFORMATION RECEIVED AFTER INITIAL SUBMISSION ON 03/28/2024: INFORMATION FOR ONLY ONE SHEATH HAS BEEN PROVIDED BY THE SITE. THE EVENT WAS DISCOVERED WHEN THE PATIENT DEVELOPED ACUTE ABDOMINAL PAIN AND A CT SCAN WAS PERFORMED. THE PATIENT SPONTANEOUSLY RECOVERED AFTER A FEW HOURS. NO DELAY IN THE PROCEDURE WAS REPORTED. THE EVENT OUTCOME IS RESOLVED.

  Patient problems: Abdominal Pain; Pneumoperitoneum

  MAUDE report 18995740 ↗

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-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-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-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