GLIDESHEATH SLENDER 80-1660Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00389701012117), received between Dec 14, 2018 and Feb 16, 2024 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (2 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 16, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 16, 2024Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED THAT THE HUB WAS LEAKING FROM THE BACK OF THE GLIDESHEATH SLENDER SHEATH. THE PROCEDURE TYPE WAS RADIAL ACCESS HEART CATHETERIZATION. THE PATIENT WAS IN STABLE CONDITION AND THERE WAS NO BLOOD LOSS. THE EVENT OCCURRED INTRA-OPERATIVE. THERE WAS NO PATIENT INJURY MEDICAL OR SURGICAL INTERVENTION REQUIRED. THERE IS NOT A DIRECT ALLEGATION THAT THE REPORTED DEVICE CAUSED OR CONTRIBUTED TO PATIENT INJURY AND/OR NEED FOR MEDICAL INTERVENTION. ADDITIONAL INFORMATION WAS RECEIVED ON 06 FEB 2024: A GLIDEWIRE WAS USED WITH THE GLIDESHEATH SLENDER AT THE TIME OF LEAKING. THE LEAK CAME FROM THE VALVE AREA. THE LEAKING WAS NOT SIGNIFICANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18721973 ↗
• MalfunctionFeb 16, 2024Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED THAT THE HUB WAS LEAKING FROM THE BACK OF THE GLIDESHEATH SLENDER SHEATH. THE PROCEDURE TYPE WAS RADIAL ACCESS HEART CATHETERIZATION. THE PATIENT WAS IN STABLE CONDITION AND THERE WAS NO BLOOD LOSS. THE EVENT OCCURRED INTRA-OPERATIVE. THERE WAS NO PATIENT INJURY/MEDICAL OR SURGICAL INTERVENTION REQUIRED. THERE IS NOT A DIRECT ALLEGATION THAT THE REPORTED DEVICE CAUSED OR CONTRIBUTED TO PATIENT INJURY AND/OR NEED FOR MEDICAL INTERVENTION. ADDITIONAL INFORMATION WAS RECEIVED ON 06 FEB 2024: A GLIDEWIRE WAS USED WITH THE GLIDESHEATH SLENDER AT THE TIME OF LEAKING. THE LEAK CAME FROM THE VALVE AREA. THE LEAKING WAS NOT SIGNIFICANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18721913 ↗
• MalfunctionOct 7, 2020Failure to Advance; Failure to Advance

  THE USER FACILITY REPORTED THAT THE INVOLVED GLIDESHEATH SLENDER WAS USED DURING A RIGHT RADIAL CORONARY ANGIOGRAM, ACCESS WAS GAINED WITH THE NEEDLE IN THE KIT. THE WIRE IN THE KIT WOULD NOT ADVANCE THROUGH THE NEEDLE. A NEW KIT WAS OPENED AND THE WIRE FROM THAT KIT WAS USED TO ADVANCE THROUGH THE NEEDLE WITHOUT ISSUE. THE PROCEDURE CONTINUED WITHOUT ISSUE. THE PATIENT'S CONDITION WAS STABLE, AND THEY WERE DISCHARGED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE ESTIMATED BLOOD LOSS WAS LESS THAN 250CC'S. THERE WAS NO PATIENT INJURY, MEDICAL/SURGICAL INTERVENTION REQUIRED. ADDITIONAL INFORMATION WAS RECEIVED ON 18SEP2020. THE PHYSICIAN STATED THAT WHEN THE WIRE WOULD NOT FIT THROUGH THE NEEDLE IN THE KIT, THEY OPENED ANOTHER KIT AND THAT WIRE DID FIT THROUGH THE NEEDLE. SHE TRIED PUTTING THE WIRE THAT WAS RETURNED THROUGH THE NEEDLE FROM THE SECOND KIT AND IT WOULD NOT GO THROUGH THAT NEEDLE EITHER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10641475 ↗
• MalfunctionDec 14, 2018Failure to Advance; Failure to Advance

  THE USER FACILITY REPORTED THAT A WIRE WOULD NOT ADVANCE THROUGH THE NEEDLE INCLUDED IN THE 16CM SLENDER KIT. THERE WAS NORMAL BLOOD FLOW ONCE THE RADIAL ARTERY WAS ACCESSED BUT THE WIRE WOULD NOT PASS THROUGH THE NEEDLE. A NEW KIT WAS OPENED AND USED SUCCESSFULLY. THE PATIENT WAS STABLE. THE PROCEDURE OUTCOME WAS SUCCESSFUL. THERE WAS NO OTHER EQUIPMENT OR DEVICES BEING USED WITH THE REPORTED PRODUCT OTHER THAN WHAT CAME IN THE KIT. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2018: THE PROCEDURE BEING PERFORMED WAS A DIAGNOSIS CORONARY ANGIO THAT TURNED INTERVENTIONAL. THEN AN INTERVENTIONAL GUIDE AND SUCH WERE INSERTED ONCE SUCCESSFUL ACCESS WAS OBTAINED. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2018: THE PROCEDURE BEING PERFORMED WAS A DIAGNOSIS CORONARY ANGIO THAT TURNED INTERVENTIONAL. THEN AN INTERVENTIONAL GUIDE AND SUCH WERE INSERTED ONCE SUCCESSFUL ACCESS WAS OBTAINED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8166284 ↗