SafeSheath® II SSL6Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 30891492002327), received between May 24, 2024 and Dec 31, 2024 — classified as 3 malfunctions.

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

• MalfunctionDec 31, 2024Difficult to Remove; Difficult to Remove

  THE 4076 LEAD WAS UNABLE TO PASS THRU THE 6FR SAFE SHEATH INTRODUCER LOT # DP17030 AND OPITSEAL LOT #W8949751. THE LEAD WAS NOT ABLE TO BE PULLED BACK FROM THE OPTISEAL W8949751. THE OPTISEAL WAS THEN SPLIT TO HELP REMOVE OR EXTRACT THE LEAD FROM THE VENOUS SYSTEM. AS A RESULT, THE HELIX "STRETCHED" OUT. PRODUCT RETURNING. ADDITIONAL INFORMATION REPORTED BY CUSTOMER ON 12/16/2024: IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, THE PACING LEAD COULD NOT BE INSERTED INTO THE CATHETER. INSERTION/WITHDRAWAL RESISTANCE WAS OBSERVED AND THE LEAD WAS UNABLE TO BE WITHDRAWN FROM THE SHEATH INTRODUCER. THE INTRODUCER WAS THEN SPLIT TO HELP REMOVE/EXTRACT THE LEAD FROM THE VENOUS SYSTEM RESULTING IN THE HELIX "STRETCHED" OUT. THE LEAD AND THE DELIVERY SYSTEM WAS ATTEMPTED, NOT USED AND WAS REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. THE OPTISEAL VALVED PTFE PEELABLE INTRODUCER IS INTENDED FOR USE IN PERCUTANEOUS INSERTION OF PACING LEADS OR CATHETERS IN THE VENOUS SYSTEM. PROCEDURE TYPE IS IMPLANT OF IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM. PATIENT INITIALS: FM, AGE 78 YEARS, SEX MALE. AVAILABLE FOR RETURN, PLEASE FORWARD RGA/RMA NUMBER TO FACILITATE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21047270 ↗
• MalfunctionMay 24, 2024Break; Material Too Rigid or Stiff; Break; Material Too Rigid or Stiff

  CUSTOMER REPORTED THAT THE HOSPITAL IS HAVING AN ISSUE WITH THE SS II. THE "IN POCKET" SHEATH WAS A SHORTY (10 CM), AND THE "ON THE STERILE FIELD" WAS THE LONGER 23 OR 25CM VERSION. SAME PATIENT. WE OPENED THREE TOTAL SHEATHS FOR THE CASE, BUT ONLY USED TWO PHYSICALLY IN THE PATIENT. THE THIRD SHEATH WAS OPENED, WE NEVER USED ON THE PATIENT. REPORTED LOT NUMBERS ARE: DP20547 & DP20522. IT IS UNKNOWN WHICH VIDEO BELONGS TO THE TWO LOT NUMBERS REPORTED. DP20547 (23 CM) WILL BE PROCESSED UNDER (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19395463 ↗
• MalfunctionMay 24, 2024Break; Material Too Rigid or Stiff; Break; Material Too Rigid or Stiff

  CUSTOMER REPORTED THAT THE HOSPITAL IS HAVING AN ISSUE WITH THE SS II. THE "IN POCKET" SHEATH WAS A SHORTY (10 CM), AND THE "ON THE STERILE FIELD" WAS THE LONGER 23 OR 25CM VERSION. SAME PATIENT. WE OPENED THREE TOTAL SHEATHS FOR THE CASE, BUT ONLY USED TWO PHYSICALLY IN THE PATIENT. THE THIRD SHEATH WAS OPENED, WE NEVER USED ON THE PATIENT. REPORTED LOT NUMBERS ARE: DP20547 & DP20522. IT IS UNKNOWN WHICH VIDEO BELONGS TO THE TWO LOT NUMBERS REPORTED. DP20547 (23 CM) WILL BE PROCESSED UNDER (B)(4). DP20522 (13 CM) WILL BE PROCESSED UNDER (B)(4) .

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19393157 ↗

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-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-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