Super Sheath R/O (15-963B) BT70Z11PPWX38Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 04543527181815), received between Apr 29, 2019 and Apr 15, 2020 — classified as 14 malfunctions.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (11 reports).

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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 15, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THERE WAS CONDENSATION IN THE PACKAGING. A 7 FR X 11 CM SUPER SHEATH INTRODUCER SHEATH WAS SELECTED FOR USE. CONDENSATION WAS NOTED INSIDE THE INTERNAL PACKAGING AT THE HUB OF THE SHEATH. NO PATIENT WAS INVOLVED AT THE TIME OF THE EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 9964536 ↗
• MalfunctionApr 15, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THERE WAS CONDENSATION IN THE PACKAGING. A 7 FR X 11 CM SUPER SHEATH INTRODUCER SHEATH WAS SELECTED FOR USE. CONDENSATION WAS NOTED INSIDE THE INTERNAL PACKAGING AT THE HUB OF THE SHEATH. NO PATIENT WAS INVOLVED AT THE TIME OF THE EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 9964350 ↗
• MalfunctionApr 14, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THERE WAS CONDENSATION IN THE PACKAGING. THE 7 FR X 11 CM SUPER SHEATH INTRODUCER SHEATH WAS FOUND TO HAVE BEADS OF FLUID APPEARING TO BE CONDENSATION AT THE HUB OF THE SHEATH INSIDE THE INTERNAL STERILE PACKAGING. NO PATIENT WAS INVOLVED AT THE TIME OF THE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9958821 ↗
• MalfunctionApr 14, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THERE WAS CONDENSATION IN THE PACKAGING. THE 7 FR X 11 CM SUPER SHEATH INTRODUCER SHEATH WAS FOUND TO HAVE BEADS OF FLUID APPEARING TO BE CONDENSATION AT THE HUB OF THE SHEATH INSIDE THE INTERNAL STERILE PACKAGING. NO PATIENT WAS INVOLVED AT THE TIME OF THE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9958239 ↗
• MalfunctionApr 14, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THERE WAS CONDENSATION IN THE PACKAGING. THE 7 FR X 11 CM SUPER SHEATH INTRODUCER SHEATH WAS FOUND TO HAVE BEADS OF FLUID APPEARING TO BE CONDENSATION AT THE HUB OF THE SHEATH INSIDE THE INTERNAL STERILE PACKAGING. NO PATIENT WAS INVOLVED AT THE TIME OF THE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9958203 ↗
• MalfunctionApr 14, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THERE WAS CONDENSATION IN THE PACKAGING. THE 7 FR X 11 CM SUPER SHEATH INTRODUCER SHEATH WAS FOUND TO HAVE BEADS OF FLUID APPEARING TO BE CONDENSATION AT THE HUB OF THE SHEATH INSIDE THE INTERNAL STERILE PACKAGING. NO PATIENT WAS INVOLVED AT THE TIME OF THE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9957851 ↗
• MalfunctionApr 14, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THERE WAS CONDENSATION IN THE PACKAGING. THE 7 FR X 11 CM SUPER SHEATH INTRODUCER SHEATH WAS FOUND TO HAVE BEADS OF FLUID APPEARING TO BE CONDENSATION AT THE HUB OF THE SHEATH INSIDE THE INTERNAL STERILE PACKAGING. NO PATIENT WAS INVOLVED AT THE TIME OF THE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9957340 ↗
• MalfunctionApr 14, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THERE WAS CONDENSATION IN THE PACKAGING. THE 7 FR X 11 CM SUPER SHEATH INTRODUCER SHEATH WAS FOUND TO HAVE BEADS OF FLUID APPEARING TO BE CONDENSATION AT THE HUB OF THE SHEATH INSIDE THE INTERNAL STERILE PACKAGING. NO PATIENT WAS INVOLVED AT THE TIME OF THE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9957282 ↗
• MalfunctionApr 14, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THERE WAS CONDENSATION IN THE PACKAGING. THE 7 FR X 11 CM SUPER SHEATH INTRODUCER SHEATH WAS FOUND TO HAVE BEADS OF FLUID APPEARING TO BE CONDENSATION AT THE HUB OF THE SHEATH INSIDE THE INTERNAL STERILE PACKAGING. NO PATIENT WAS INVOLVED AT THE TIME OF THE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9957226 ↗
• MalfunctionApr 14, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THERE WAS CONDENSATION IN THE PACKAGING. THE 7 FR X 11 CM SUPER SHEATH INTRODUCER SHEATH WAS FOUND TO HAVE BEADS OF FLUID APPEARING TO BE CONDENSATION AT THE HUB OF THE SHEATH INSIDE THE INTERNAL STERILE PACKAGING. NO PATIENT WAS INVOLVED AT THE TIME OF THE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9957211 ↗
• MalfunctionApr 13, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THERE WAS CONDENSATION IN THE PACKAGING. A 7 FR X 11 CM SUPER SHEATH INTRODUCER SHEATH WAS SELECTED FOR USE. CONDENSATION WAS NOTED INSIDE THE INTERNAL PACKAGING AT THE HUB OF THE SHEATH. NO PATIENT WAS INVOLVED AT THE TIME OF THE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9954684 ↗
• MalfunctionApr 29, 2019Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT THERE WAS FLUID WITHIN THE STERILE PACKAGE. FLUID WAS OBSERVED IN THE SUPER SHEATH INTRODUCER SHEATH STERILE PACKAGE NEAR THE END OF THE SHEATH. THE FLUID WAS VISIBLE WITHOUT OPENING THE PACKAGE. THE PACKAGING APPEARED NORMAL AND WAS INTACT. THERE WERE NUMEROUS SUPER SHEATH INTRODUCER SHEATH DEVICES OBSERVED TO HAVE THIS ISSUE. ONE OF THE PACKAGES WAS OPENED AND THE SUBSTANCE WAS NOTED TO BE OILY. THE DEVICES ARE ALL IN THEIR PACKAGES AND WERE NOT USED WITH A PATIENT.

  Patient problems: No Patient Involvement

  MAUDE report 8562387 ↗
• MalfunctionApr 29, 2019Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT THERE WAS FLUID WITHIN THE STERILE PACKAGE. FLUID WAS OBSERVED IN THE SUPER SHEATH INTRODUCER SHEATH STERILE PACKAGE NEAR THE END OF THE SHEATH. THE FLUID WAS VISIBLE WITHOUT OPENING THE PACKAGE. THE PACKAGING APPEARED NORMAL AND WAS INTACT. THERE WERE NUMEROUS SUPER SHEATH INTRODUCER SHEATH DEVICES OBSERVED TO HAVE THIS ISSUE. ONE OF THE PACKAGES WAS OPENED AND THE SUBSTANCE WAS NOTED TO BE OILY. THE DEVICES ARE ALL IN THEIR PACKAGES AND WERE NOT USED WITH A PATIENT.

  Patient problems: No Patient Involvement

  MAUDE report 8562287 ↗
• MalfunctionApr 29, 2019Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT THERE WAS FLUID WITHIN THE STERILE PACKAGE. FLUID WAS OBSERVED IN THE SUPER SHEATH INTRODUCER SHEATH STERILE PACKAGE NEAR THE END OF THE SHEATH. THE FLUID WAS VISIBLE WITHOUT OPENING THE PACKAGE. THE PACKAGING APPEARED NORMAL AND WAS INTACT. THERE WERE NUMEROUS SUPER SHEATH INTRODUCER SHEATH DEVICES OBSERVED TO HAVE THIS ISSUE. ONE OF THE PACKAGES WAS OPENED AND THE SUBSTANCE WAS NOTED TO BE OILY. THE DEVICES ARE ALL IN THEIR PACKAGES AND WERE NOT USED WITH A PATIENT.

  Patient problems: No Patient Involvement

  MAUDE report 8562045 ↗