GLIDESHEATH 30-2560Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00389701011264), received between Dec 28, 2020 and Dec 28, 2020 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 28, 2020Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED THAT THE GLILDESHEATH HAD A LEAKY VALVE. THERE WAS NOT PATIENT INJURY/MEDICAL OR SURGICAL INTERVENTION REQUIRED. THE PATIENT WAS IN STABLE CONDITION. THE PROCEDURE OUTCOME WAS SUCCESSFUL. THERE WERE NO OTHER DEVICES OR EQUIPMENT USED WITH THE REPORTED PRODUCT. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6).2020. THE ESTIMATED BLOOD LOSS WAS LESS THAN 250CC. THE PROCEDURE WAS COMPLETED USING THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11078327 ↗
• MalfunctionDec 28, 2020Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED THAT THE GLILDESHEATH HAD A LEAKY VALVE. THERE WAS NOT PATIENT INJURY/MEDICAL OR SURGICAL INTERVENTION REQUIRED. THE PATIENT WAS IN STABLE CONDITION. THE PROCEDURE OUTCOME WAS SUCCESSFUL. THERE WERE NO OTHER DEVICES OR EQUIPMENT USED WITH THE REPORTED PRODUCT. ADDITIONAL INFORMATION WAS RECEIVED ON 07DEC2020. THE ESTIMATED BLOOD LOSS WAS LESS THAN 250CC. THERE WERE TWO DEVICES USED DURING THE SAME PROCEDURE AND BOTH DEVICES LEAKED. THE PROCEDURE WAS COMPLETED USING THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11078310 ↗
• MalfunctionDec 28, 2020Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED THAT THE GLILDESHEATH HAD A LEAKY VALVE. THERE WAS NOT PATIENT INJURY/MEDICAL OR SURGICAL INTERVENTION REQUIRED. THE PATIENT WAS IN STABLE CONDITION. THE PROCEDURE OUTCOME WAS SUCCESSFUL. THERE WERE NO OTHER DEVICES OR EQUIPMENT USED WITH THE REPORTED PRODUCT. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2020. THE ESTIMATED BLOOD LOSS WAS LESS THAN 250CC. THERE WERE TWO DEVICES USED DURING THE SAME PROCEDURE AND BOTH DEVICES LEAKED. THE PROCEDURE WAS COMPLETED USING THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11078292 ↗