Super Sheath R/O (15-964B) BT80Z11PPWX38Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 04543527181822), received between Sep 11, 2018 and Apr 14, 2020 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (7 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• 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 8 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 9958333 ↗
• 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. A 8 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 9958214 ↗
• 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. A 8 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 9958035 ↗
• 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. A 8 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 9957537 ↗
• 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 8 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 9957175 ↗
• 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 8 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 9954591 ↗
• 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 8 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 9954550 ↗
• MalfunctionSep 11, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED VIA USER FACILITY MEDWATCH REPORT # MW5079066 THAT A SHEATH FRACTURE OCCURRED. A 8FR X 11CM N/G SUPER SHEATH INTRODUCER SHEATH WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT DURING VASCULAR ACCESS, THE SHEATH FRACTURED WITH ACTIVE EXTRAVASATION AROUND THE SHEATH ENTRY SITE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7865485 ↗