GLIDESHEATH 40-1060Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00389701011042), received between Dec 21, 2016 and Nov 3, 2024 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 3, 2024Break; Break

  THE USER FACILITY REPORTED THAT FOLLOWING DEVICE REMOVAL OF THE GUIDEPOST AFTER PERCUTANEOUS CORONARY INTERVENTION (PCI), IT WAS NOTED THAT THE VALVE ON THE 6FR GLIDESHEATH WAS STUCK OPEN, RESULTING IN ARTERIAL BLOOD BEING OBSERVED AT THE END OF THE SHEATH WHERE THE VALVE IS LOCATED. MANUAL PRESSURE AND A TR BAND WERE APPLIED, AND THE HEMATOMA WAS EXPRESSED.

  Patient problems: Hematoma

  MAUDE report 20595800 ↗
• MalfunctionMar 5, 2021Break; Break

  THE USER FACILITY REPORTED THAT DURING THE PROCEDURE, WHEN THE GLIDESHEATH WAS OPENED FROM THE PACKAGING, THE TIP WAS SNAPPED OFF. THE OTHER FOUR IN THE BOX WERE NOT DAMAGED AND ANOTHER ONE FROM THAT BOX WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY/MEDICAL OR SURGICAL INTERVENTION REQUIRED. THE PATIENT WAS IN STABLE CONDITION AND THE PROCEDURE OUTCOME WAS SUCCESSFUL. ADDITIONAL INFORMATION WAS RECEIVED ON 15FEB2021. THE DILATOR TIP WAS ALREADY BROKEN WHEN THE PACKAGE WAS FIRST OPENED. THE PACKAGE WAS CAREFULLY OPENED WHEN THE SURGICAL TABLE WAS BEING SET UP FOR THE PROCEDURE. WHEN THEY NOTICED THAT THE TIP WAS BROKEN, THEY SET IT ASIDE AND GRABBED A NEW PACKAGE. THERE WAS NO PATIENT INVOLVEMENT. THE DEVICES ARE STORED IN THEIR PACKAGING, HANGING ON A SHELF IN THE OPERATING ROOM. THE ROOM IS KEPT COOL AND DRY AND THE PRODUCTS ARE NOT JOSTLED AROUND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11425690 ↗
• MalfunctionAug 22, 2017Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED THEY HAD A SHEATH THAT WAS LEAKING AT THE VALVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE USER FACILITY: BLOOD LOSS WAS APPROXIMATELY 10CC'S. ADDITIONAL INFORMATION WAS RECEIVED ON JULY 31,2017. THE PATIENT WAS STABLE. THE PROCEDURE OUTCOME WAS SUCCESSFUL. A 5FR CATH IMPULSE WAS USED WITH THE REPORTED PRODUCT.

  Patient problems: Blood Loss; No Consequences Or Impact To Patient

  MAUDE report 6810797 ↗
• MalfunctionAug 10, 2017Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED VALVE LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE USER FACILITY: CUSTOMER STATES THAT THE VALVE IS LEAKING (MODERATE-SEVERE) MORE THAN USUAL WHEN THERE IS NOTHING IN THE VALVE (WIRE, CATHETER, ETC.). USED WITH .035 3 MM J WIRE. BLOOD LOSS WAS REPORTED TO BE LESS THAN 250 CC. THE PROCEDURE OUTCOME WAS SUCCESSFUL. IT WAS REPORTED THAT THERE WAS NO PATIENT ISSUES.

  Patient problems: Blood Loss; No Consequences Or Impact To Patient

  MAUDE report 6785924 ↗
• MalfunctionAug 10, 2017Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED VALVE LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE USER FACILITY: CUSTOMER STATES THAT THE VALVE IS LEAKING (MODERATE-SEVERE) MORE THAN USUAL WHEN THERE IS NOTHING IN THE VALVE (WIRE, CATHETER, ETC.). USED WITH .035 3MM J WIRE. BLOOD LOSS WAS REPORTED TO BE LESS THAN 250CC. THE PROCEDURE OUTCOME WAS SUCCESSFUL. IT WAS REPORTED THAT THERE WAS NO PATIENT ISSUES.

  Patient problems: Blood Loss; No Consequences Or Impact To Patient

  MAUDE report 6785785 ↗
• MalfunctionAug 10, 2017Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED VALVE LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE USER FACILITY: CUSTOMER STATES THAT THE VALVE IS LEAKING (MODERATE-SEVERE) MORE THAN USUAL WHEN THERE IS NOTHING IN THE VALVE (WIRE, CATHETER, ETC.). USED WITH .035 3MM J WIRE. BLOOD LOSS WAS REPORTED TO BE LESS THAN 250CC. THE PROCEDURE OUTCOME WAS SUCCESSFUL. IT WAS REPORTED THAT THERE WAS NO PATIENT ISSUES.

  Patient problems: Blood Loss; No Consequences Or Impact To Patient

  MAUDE report 6785774 ↗
• MalfunctionAug 10, 2017Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED VALVE LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE USER FACILITY: CUSTOMER STATES THAT THE VALVE IS LEAKING (MODERATE-SEVERE) MORE THAN USUAL WHEN THERE IS NOTHING IN THE VALVE (WIRE, CATHETER, ETC.). USED WITH .035 3 MM J WIRE. BLOOD LOSS WAS REPORTED TO BE LESS THAN 250 CC. THE PROCEDURE OUTCOME WAS SUCCESSFUL. IT WAS REPORTED THAT THERE WAS NO PATIENT ISSUES.

  Patient problems: Blood Loss; No Consequences Or Impact To Patient

  MAUDE report 6785737 ↗
• MalfunctionDec 21, 2016Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED VALVE LEAKAGE ON THE INVOLVED DEVICE. FOLLOW UP COMMUNICATION WITH THE USER FACILITY CONFIRMED THE FOLLOWING INFORMATION: IT WAS REPORTED THAT IN TWO SEPARATE EVENTS, TWO OF THE SAME SHEATHS WERE USED AND THEY DID NOT SEAL AT THE VALVE; THIS CAUSED BLOOD TO LEAK FROM THE DEVICE; BLOOD LOSS WAS LESS THAN 250 ML; THE PROCEDURE WAS COMPLETED; AND THE PATIENT WAS REPORTED AS DOING FINE.

  Patient problems: Blood Loss; No Consequences Or Impact To Patient

  MAUDE report 6195021 ↗
• MalfunctionDec 21, 2016Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED VALVE LEAKAGE ON THE INVOLVED DEVICE. FOLLOW UP COMMUNICATION WITH THE USER FACILITY CONFIRMED THE FOLLOWING INFORMATION: IT WAS REPORTED THAT IN TWO SEPARATE EVENTS, TWO OF THE SAME SHEATHS WERE USED AND THEY DID NOT SEAL AT THE VALVE; THIS CAUSED BLOOD TO LEAK FROM THE DEVICE; BLOOD LOSS WAS LESS THAN 250 ML; THE PROCEDURE WAS COMPLETED; AND THE PATIENT WAS REPORTED AS DOING FINE.

  Patient problems: Blood Loss; No Consequences Or Impact To Patient

  MAUDE report 6194994 ↗