SAVION FLX™ H749394231851J0Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08714729978848), received between Jun 10, 2020 and Sep 19, 2023 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 18, 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.

• InjurySep 19, 2023Entrapment of Device; Material Deformation; Adverse Event Without Identified Device or Use Problem; Entrapment of Device; Material Deformation; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A GUIDEWIRE ISSUE OCCURRED. THE TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND NON-CALCIFIED BRACHIAL ARTERY BY THE ELBOW JOINT. AFTER A 5FR NON-BOSTON SCIENTIFIC (NON-BSC) INTRODUCER SHEATH WAS ADVANCED, A 0.14 SAVION WIRE WAS INSERTED TO NAVIGATE TO THE BRACHIOCEPHALIC VEIN AND AN OPTICROSS PERIPHERAL IMAGING CATHETER WAS ADVANCED FOR ULTRASOUND EXAMINATION OF THE TARGET LESION. WHEN THE CATHETER WAS TURNED ON, THE MOTOR DRIVE UNIT SUDDENLY MADE AN UNUSUAL SOUND AND AN ERROR MESSAGE APPEARED ON THE CONSOLE. UNDER FLUOROSCOPY, THE CATHETER WAS FOUND TO BE COILED UP IN THE FISTULA, WRAPPING AROUND THE WIRE, MAKING IT EXTREMELY DIFFICULT TO REMOVE. THE DEVICES COULD NOT BE PULLED OUT OF THE 5FR SHEATH AND THE CATHETER WAS NOTED TO BE FRACTURED. A NEW 8FR SHEATH WAS INSERTED AND THE FRACTURED DEVICE WAS REMOVED THROUGH A BASKET SNARE. THE WIRE WAS NOTED TO BE STRETCHED AFTER REMOVAL. THE PROCEDURE WAS COMPLETED USING A BALLOON. NO PATIENT COMPLICATIONS WERE REPORTED AND NO LONG-TERM DAMAGE WAS NOTED ON FINAL IMAGING. THE PATIENT FULLY RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17778004 ↗
• MalfunctionMar 14, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT GUIDEWIRE DETACHMENT OCCURRED. THE TARGET LESION WAS LOCATED IN A MODERATELY TORTUOUS AND MODERATELY CALCIFIED LOOP OF THE FOOT. A SAVION FLX GUIDEWIRE WAS USED TO CROSS THE LESION. HOWEVER, THE WIRE BROKE OFF 15 INCHES DISTALLY INSIDE THE PATIENT BODY. THE PIECES OF THE WIRE WERE THEN REMOVED, AND IT CAME OUT WITH SHEATH. THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16536748 ↗
• InjuryJun 10, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE GUIDEWIRE TIP DETACHED INSIDE THE PATIENT. A SAVION FLX GUIDEWIRE WAS SELECTED FOR USE IN THE SEVERELY CALCIFIED AND STENOSED TRUNCUS. DURING THE PROCEDURE, THE GUIDEWIRE WAS ABLE TO PASS THE FIRST PART OF THE STENOSIS, BUT IT COULD NOT BE MOVED FURTHER FORWARD. AS THE PHYSICIAN WAS TRYING TO PULL IT BACK, THE TIP OF THE GUIDEWIRE DETACHED. THE GUIDEWIRE BODY WAS REMOVED FROM PATIENT AND THE DETACHED TIP OF THE GUIDEWIRE WAS LEFT IN THE TOTALLY OCCLUDED PORTION OF THE LESION. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THE PATIENT EXPERIENCED NO COMPLICATIONS AND WAS STABLE POST-PROCEDURE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 10140521 ↗