Sublime™ Radial Access Guide Sheath SRA-GS35-6F120Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05391525785165), received between Sep 8, 2023 and Nov 15, 2024 — classified as 2 injuries.

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.

• InjuryNov 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE GUIDE SHEATH WAS USED DURING A LEFT RADIAL ARTERY ACCESS PROCEDURE. DURING REMOVAL OF THE GUIDE SHEATH, THE PATIENT HAD A SIGNIFICANT ARTERIAL SPASM. A VESSEL CUT DOWN AND OTHER REMEDIES WERE REQUIRED TO REMOVE THE SHEATH. THE PROCEDURE DELAY AND OUTCOME WAS UNKNOWN AT THE TIME OF REPORT.

  Patient problems: Vasoconstriction

  MAUDE report 20700466 ↗
• InjurySep 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A 6FR GUIDE SHEATH WAS BEING USED FOR LEFT RADIAL ACCESS DURING AN ATHERECTOMY PROCEDURE. A RADIAL DRUG COCKTAIL WAS ADMINISTERED PRIOR TO THE PROCEDURE START, TO RELAX THE TARGET VESSELS. AN ULTRASOUND WAS NOT USED TO VERIFY VESSEL DIAMETER. THE GUIDE SHEATH WAS PLACED IN THE LEFT RADIAL ARTERY TO ACCESS THE LEFT LEG. IT WAS NOTED RESISTANCE WAS ENCOUNTERED DURING GUIDE SHEATH PLACEMENT. AN ORBITAL ATHERECTOMY SYSTEM (OAS) WAS USED IN CONJUNCTION WITH A BALLOON IN THE SUPERFICIAL FEMORAL ARTERY (SFA). IT WAS REPORTED THAT "EVERYTHING LOOKED GOOD" UNTIL THAT POINT. DURING DEVICE REMOVAL, THE PATIENT HAD A VESSEL SPASM, AND THE PHYSICIAN WAS UNABLE TO REMOVE THE SHEATH FROM THE PATIENT'S LEFT RADIAL ARTERY. THE PHYSICIAN WAS USING A 0.014" GUIDEWIRE WITHOUT A DILATOR. DURING THE REMOVAL PROCESS, THE SHEATH STRETCHED AND AT ONE POINT THE BRAIDS WERE EXPOSED. FURTHERMORE, THE "SHEATH WAS NO LONGER ON AND IT WAS JUST THE BRAID." AT THAT TIME, THE PHYSICIAN MOVED FURTHER DOWN THE SHEATH WITH HEMOSTATS AND PULLED WITH THE HEMOSTATS APPROXIMATELY 5 CM AT A TIME. THIS MANEUVER WAS REPEATED DOWN THE SHEATH UNTIL IT COULD NOT BE WITHDRAWN ANYMORE. THE PHYSICIAN NOTIFIED A SURGEON, AND THE PA

  Patient problems: Vasoconstriction

  MAUDE report 17715808 ↗