SAVION FLX™ H7493942318510Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08714729978831), received between Apr 18, 2019 and May 14, 2021 — classified as 2 injuries, 1 malfunction.

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

• InjuryMay 14, 2021Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT GUIDEWIRE TIP DETACHMENT OCCURRED. THE CHRONIC TOTALLY OCCLUDED TARGET LESION WITH MODERATE TO SEVERE CALCIFICATION WAS LOCATED IN THE MODERATELY TORTUOUS ANTERIOR TIBIAL ARTERY (ATA). THE VESSEL WAS VERY DISEASED AND HAD SEVERAL OCCLUSIONS DOWN THE VESSEL BEFORE REFILLING CLOSE TO THE FOOT. A SAVION FLX GUIDEWIRE WAS PREPPED AND ADVANCED THROUGH A 2.6F NON-BSC SUPPORT CATHETER. WITHIN A MINUTE, THE TIP OF THE GUIDEWIRE BROKE OFF APPROXIMATELY HALFWAY DOWN THE ATA AND BECAME LODGED IN SITU. THE REMAINDER OF THE SAVION FLX GUIDEWIRE WAS REMOVED, AND THEN A NON-BSC GUIDEWIRE WAS USED WITHOUT ISSUE. THE CASE WAS ABANDONED. THE PATIENT WAS STABLE. AN ATTEMPT WILL BE MADE AGAIN SHOULD THE BLOOD FLOW TO THE TOE AMPUTATION WOUND SITE NOT BE SUFFICIENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 11828352 ↗
• InjurySep 3, 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 A PROCEDURE WITH RETROGRADE ACCESS AND A 5F SHEATH. DURING THE PROCEDURE, THE TIP OF THE GUIDEWIRE DETACHED IN THE DISTAL ANTERIOR TIBIAL ARTERY. THERE WAS NO WAY TO RETRIEVE THE GUIDEWIRE FRAGMENT. FLOW TO THE PATIENT'S ARTERY WAS NOT AFFECTED. IT WAS FURTHER REPORTED THAT THE LESION WAS EXTREMELY CALCIFIED AND STENOSIS WAS 90%. ATTEMPTS WERE MADE TO RETRIEVE THE DETACHED WIRE BY ASPIRATION AND USING A SNARE CATHETER, BUT IT WAS IRRETRIEVABLE. THE PROCEDURE WAS RESCHEDULED AND A STENT WAS USED TO AFFIX AND APPOSE THE DETACHED TIP AGAINST THE VESSEL WALL.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 10488554 ↗
• MalfunctionApr 18, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT A TIP SEPARATION OCCURRED. A SAVION FLX GUIDEWIRE WAS SELECTED FOR USE. DURING PREPARATION OUTSIDE THE PATIENT, THE PHYSICIAN ATTEMPTED TO GENTLY SHAPE THE DISTAL TIP. NO STRENGTH WAS USED AND NO RESISTANCE WAS FELT WHILE TRYING TO SHAPE THE TIP; HOWEVER THE DISTAL TIP BROKE AND TORE APART. THE PRODUCT WAS NOT USED INSIDE THE PATIENT AND THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 8528076 ↗