HyperGlide 104-4113Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00763000294380), received between Jan 23, 2025 and Jan 23, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Leak/Splash” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 23, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING THE PREPARATION OF A HYPERGLIDE 4.0 X 10 MM TIP SYSTEM FOR A PROCEDURE INVOLVING A FLOW DIVERTOR, A BALLOON LEAK OCCURRED. THE PROCEDURE WAS INTENDED TO DEFLATE THE BALLOON TO ASSIST THE STENTBRAID IN EXPANDING AND APPOSING THE VESSEL WALL. THE BALLOON LEAK WAS IDENTIFIED DURING PREPARATION, AND A NEW DEVICE WAS USED. THE PATIENT HAD A MEDICAL HISTORY OF HEADACHE WITH ANEURYSM, BUT NO SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT. THE PATIENT OUTCOME WAS REPORTED AS ALIVE WITH NO INJURY. ADDITIONAL INFORMATION RECEIVED REPORTED THE BALLOON LEAK WAS DURING THE PREPARATION BEFORE THE PROCEDURE (NOTED CAUSE). THE BALLOON WAS LEAKING FLUID (SALINE AND CONTRAST). THE BALLOON INFLATED AND THE PHYSICIAN FOUND THE FLUID. THE FLUID LEAK WAS NOTED IN THE PROXIMAL END OF THE BALLOON. THE PREPARATION WAS FOLLOWING THE INSTRUCTIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21219040 ↗