Super Sheath (15-712B) BT60Z11PGW035 (UDI 04543527202442)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04543527202442), received between May 23, 2022 and Dec 17, 2025 — classified as 2 injuries.

The most frequently reported specific device problem is “Break” (1 report).

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.

• InjuryDec 17, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE DEVICE BROKE OFF, REQUIRING ADDITIONAL INTERVENTION FOR REMOVAL. A 6 FR X 11 CM .035 SUPER SHEATH INTRODUCER SHEATH WAS SELECTED FOR PLACEMENT. DURING THE PROCEDURE, THERE WAS NO RESISTANCE NOTED WHEN THE SUPER SHEATH DEVICE WAS ADVANCED IN THE VESSEL. HOWEVER, UPON COMPLETION OF THE PROCEDURE, IT WAS NOTED THAT THE DEVICE BROKE UNDER FLUOROSCOPIC VISUALIZATION. AN ATTEMPT WAS MADE TO EXTRACT THE FOREIGN BODY USING A NON-BOSTON SCIENTIFIC (NON-BSC) SNARE, WITHOUT SUCCESS. THE DETACHED PORTION OF THE DEVICE REMAINED IN THE COMMON FEMORAL ARTERY. A NON-BSC 7 FR FEMORAL INTRODUCER WAS THEN REPLACED, FOLLOWED BY AN 8 FR FEMORAL INTRODUCER. THE SYSTEM WAS MOUNTED ON A 7 FR JR 3.5 GUIDE CATHETER, ALSO WITHOUT SUCCESS. ADDITIONALLY, A NON-BSC LOOP-SHAPED ANGIOPLASTY GUIDE WAS USED, BUT AFTER MULTIPLE FAILED ATTEMPTS TO RETRIEVE THE DEVICE, THE PROCEDURE WAS TERMINATED DUE TO THE HIGH RISK OF ASSOCIATED VASCULAR COMPLICATIONS. THE PATIENT UNDERWENT OPEN SURGERY TO EXPLORE AND RETRIEVED THE INTRODUCER SHEATH. THE CARDIAC CATHETERIZATION PROCEDURE WAS COMPLETED. THE PATIENT FULLY RECOVERED POST-PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23829396 ↗
• InjuryMay 23, 2022Break; Break

  IT WAS REPORTED THAT THE INTRODUCER WAS FRACTURED AND THE CANNULA HAD TO BE REMOVED THROUGH AN INTRAVASCULAR RETRIEVER. THE TARGET LESION WAS LOCATED IN THE RIGHT COMMON FEMORAL ARTERY. A 6FR X 11CM SUPER SHEATH INTRODUCER SHEATH WAS SELECTED FOR USE. DURING REMOVAL, IT WAS NOTED THAT THE INTRODUCER GOT FRACTURED AND THE CANNULA WAS LEFT INSIDE THE PATIENT. CONSEQUENTLY, AN INTRAVASCULAR RETRIEVER HAD TO BE USED FOR ITS EXTRACTION AND THE PROCEDURE WAS COMPLETED. THERE WERE NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14469050 ↗