SAVION FLXRecalls & reported problems across all models

We found 4 models of SAVION FLX by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 69 adverse event reports in the FDA's MAUDE database, received between Sep 17, 2018 and Sep 30, 2024 — classified as 48 injuries, 21 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (55 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported SAVION FLX problems

SAVION FLX models

4 models, most reported first. Each model has its own page with its reports, recalls and device details.

• SAVION FLX™ H7493942230010

  Wire, guide, catheter
  36 reports
• SAVION FLX™ H749394223001J0

  Wire, guide, catheter
  27 reports
• SAVION FLX™ H7493942318510

  Wire, guide, catheter
  3 reports
• SAVION FLX™ H749394231851J0

  Wire, guide, catheter
  3 reports

Recent SAVION FLX adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjurySep 30, 2024Detachment 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 TIP DETACHMENT OCCURRED, REQUIRING SNARE FOR REMOVAL. THE TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED TIBIAL VESSELS. A SAVION FLX GUIDEWIRE WAS SELECTED FOR RIGHT LOWER EXTREMITY ARTERIOGRAM. DURING THE PROCEDURE, THE PHYSICIAN ATTEMPTED TO CROSS THE TORTUOUS ANATOMY AT THE PATIENT'S DORSALIS PEDIS OR LOOP ARTERY. HOWEVER, WHILE CROSSING THE WIRE THROUGH THE ARTERY, THE DISTAL END OF THE GUIDEWIRE TIP BROKE OFF AND DETACHED FROM THE REMAINING WIRE END. THE PHYSICIAN HAD TO USE A SNARE DEVICE TO CAPTURE THE BROKEN TIP OF THE WIRE AND REMOVE IT FROM THE PATIENT'S ARTERY. THE PROCEDURE WAS COMPLETED USING A NON-BOSTON SCIENTIFIC (BSC) GUIDEWIRE. NO PATIENT COMPLICATIONS WERE REPORTED. IT WAS FURTHER REPORTED THAT THE CORRECT DEVICE USED IN THE PROCEDURE WAS V-14 CONTROL WIRE. THE SAVION FLX GUIDEWIRE WAS NOT USED IN THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20334638 ↗
• MalfunctionJul 18, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE TIP OF THE GUIDEWIRE BROKE. THE PATIENT WAS BEING TREATED FOR CRITICAL LIMB ISCHEMIA. THE 85% STENOSED TARGET LESION WAS LOCATED IN A MODERATELY TORTUOUS AND MODERATELY CALCIFIED VESSEL. A SAVION FLX GUIDEWIRE WAS USED DURING VASCULAR ANGIOPLASTY. HOWEVER, WHILE TRYING TO CROSS THE LESION, THE TIP OF THE GUIDEWIRE BROKE. THE FRACTURED PORTION OF THE DEVICE WAS PULLED AND REMOVED FROM THE PATIENT'S BODY. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19777611 ↗
• InjuryMay 17, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT TIP DETACHMENT OCCURRED. A SAVION FLX GUIDEWIRE WAS SELECTED FOR USE ALONG WITH AN 0.14 RUBICON GUIDE CATHETER TO CROSS THE OCCLUDED ANTERIOR TIBIAL ARTERY. HOWEVER, THE TIP OF THE WIRE SNAPPED OFF IN THE OCCLUDED VESSEL. THE PHYSICIAN HAS NO PLANS IN REMOVING THE DETACHED FRAGMENT AS THE PATIENT WILL BE IN GREATER RISK IN TRYING TO RETRIEVE IT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT WIRE. NO COMPLICATIONS WERE REPORTED. THE PATIENT WAS FINE POST PROCEDURE AND FULLY RECOVERED.

  Patient problems: Foreign Body In Patient

  MAUDE report 19346944 ↗
• InjuryMay 10, 2024Entrapment of Device; Detachment of Device or Device Component; Entrapment of Device; Detachment of Device or Device Component

  IT WAS REPORTED THAT TIP DETACHMENT OCCURRED AND REMAINED INSIDE THE PATIENT. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND MILDLY CALCIFIED MID ARTERY. A SAVION FLX GUIDEWIRE WAS SELECTED FOR USE. DURING THE PROCEDURE, UPON CROSSING THE LESION, THERE WAS RESISTANCE, AND WIRE BECAME STUCK. CONSEQUENTLY, IT WAS NOTED THAT THE TIP BROKE OFF IN SUBINTIMAL PLANE. THE GUIDEWIRE WAS REMOVED FRACTURED. THERE WERE ATTEMPTS TO REMOVE THE DETACHED TIP BY FLUSHING, HOWEVER, IT WAS DECIDED TO LEAVE IT INSIDE THE PATIENT AS IT WAS NON FLOW LIMITING. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT WAS FULLY RECOVERED.

  Patient problems: Foreign Body In Patient

  MAUDE report 19286621 ↗
• 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 ↗
• InjurySep 12, 2023Detachment of Device or Device Component; Difficult to Advance; Detachment of Device or Device Component; Difficult to Advance

  IT WAS REPORTED THAT THE GUIDEWIRE BROKE, REQUIRING ADDITIONAL INTERVENTION. THIS SAVION FLX GUIDEWIRE WAS SELECTED FOR USE IN A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE OF THE CRURAL ARTERIES BELOW THE KNEE. THIS GUIDEWIRE HAD A SMOOTH PASSAGE TO THE 20% STENOSED, MILDLY CALCIFIED ANTERIOR TIBIAL ARTERY WITH NO DIFFICULTIES OBTAINING THE CORRECT POSITIONING OF THE GUIDEWIRE. THEN PTA WAS SUCCESSFULLY PERFORMED WITH A NON-BOSTON SCIENTIFIC BALLOON OVER THIS GUIDEWIRE. THE BALLOON WAS REMOVED AND WAS REPLACED WITH A LARGER BALLOON; HOWEVER, WHEN ADVANCING THE LARGER BALLOON, RESISTANCE WAS FELT, AND IT WAS NOTED THE NON-BOSTON SCIENTIFIC CATHETER WAS NOT AT THE SAME LOCATION AS THE GUIDEWIRE. IT WAS THEN VISUALIZED THAT THE GUIDEWIRE WAS BROKEN APPROXIMATELY 30CM FROM THE TIP. THE PIECE OF GUIDEWIRE WAS REMOVED VIA SNARING AND THE PROCEDURE WAS COMPLETED USING A NEW GUIDEWIRE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17728495 ↗
• InjuryJun 30, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT TIP DETACHMENT OCCURRED REQUIRING ADDITIONAL INTERVENTION. THE 50% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED ANTERIOR TIBIAL ARTERY (ATA). AN 18 OPTICROSS PERIPHERAL CATHETER WAS PLACED IN THE LEFT LEG ANTE-GRADE STICK OVER A 0.014 SAVION FLX GUIDEWIRE. WHILE USING THE INTRAVASCULAR ULTRASOUND (IVUS), THE TRANSDUCER ELEMENT WENT OUT WHILE IMAGING THE ARCH OF THE FOOT. HOWEVER, IT WAS NOTED THAT APPROXIMATELY 10 CM OF THE DISTAL END OF THE IVUS CATHETER HAD FRACTURED OFF INSIDE THE ARTERY UPON REMOVING THE DEVICE. AFTER THE DEVICE WAS REMOVED, IT WAS ALSO NOTED THAT A SMALL PIECE OF THE SAVION FLX GUIDEWIRE WAS IN THE ATA. A SNARE WAS USED TO RETRIEVE THE PIECE OF SAVION WIRE AND 18 OPTICROSS PERIPHERAL CATHETER. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE AND THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17239150 ↗
• 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 ↗
• InjuryFeb 22, 2023Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component

  IT WAS REPORTED THAT GUIDEWIRE FRACTURE OCCURRED. THE TARGET LESION WAS LOCATED IN A MILDLY TORTUOUS AND MODERATELY CALCIFIED PROXIMAL ANTERIOR TIBIAL ARTERY. A SAVION FLX GUIDEWIRE WAS SELECTED FOR USED. HOWEVER, DURING ARTERIAL PERIPHERAL VASCULAR PROCEDURE, THE DEVICE WAS FRACTURED. ATTEMPTS WERE MADE TO SNARE THE REMAINDER OF THE DEVICE AND AN ADDITIONAL FEMORAL ACCESS AND ADDITION SUPPLIES WERE NEEDED TO SNARE FROM A DIFFERENT APPROACH ALONG WITH APPROXIMATELY AN ADDITIONAL HOUR OF PROCEDURE TIME. EVENTUALLY, THE WIRE WAS STRAIGHTENED BY MULTIPLE MANIPULATIONS. THE FRACTURED PIECES WERE REMOVED BY A PEDAL ACCESS SHEATH. THE PROCEDURE WAS COMPLETED WITH A NON-BSC DEVICE, AND THE PATIENT HAS FULLY RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16421799 ↗
• InjuryFeb 16, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT GUIDEWIRE TIP DETACHMENT OCCURRED. THE TARGET LESION WAS LOCATED IN A VESSEL BELOW THE KNEE. A SAVION FLX GUIDEWIRE WAS USED DURING THE PROCEDURE. HOWEVER, THE TIP OF THE GUIDEWIRE BECAME DISCONNECTED AND WAS UNABLE TO BE RETRIEVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED USING AN ALTERNATE DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 16389963 ↗
• MalfunctionOct 11, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT COATING ISSUE OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A SAVION FLX GUIDEWIRE WAS ADVANCED FOR USE. HOWEVER, WHEN PLACING THE CATHETER OVER THE WIRE, THE WIRE COATING WAS PEELED. THE DEVICE WAS REMOVED INTACT AND ANOTHER SAVION GUIDEWIRE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15584825 ↗
• InjuryJun 13, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE DETACHED GUIDEWIRE TIP COULD NOT BE RETRIEVED. A SAVION FLX WAS SELECTED FOR USE. THE GUIDEWIRE WAS ADVANCED INTO THE LOWER LEG AND INTO STENOSED AND CALCIFIED ANTERIOR TIBIAL ARTERY. THE CHANNEL WAS NARROW BUT THE GUIDEWIRE WAS PLACED. HOWEVER, THE PHYSICIAN OBSERVED THAT THE DISTAL TIP HAD DETACHED. A SNARE WAS UNSUCCESSFUL IN REMOVING THE TIP. THERE WERE NO PATIENT COMPLICATIONS AND NO FURTHER INTERVENTION IS PLANNED.

  Patient problems: Foreign Body In Patient

  MAUDE report 14681763 ↗
• MalfunctionMar 12, 2022Unraveled Material; Material Integrity Problem; Unraveled Material; Material Integrity Problem

  IT WAS REPORTED THAT COATING ISSUE OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED ANTERIOR TIBIAL ARTERY. A 3.5MM X 220MM X 150CM COYOTE BALLOON CATHETER WAS ADVANCED THROUGH SAVION FLX GUIDEWIRE; HOWEVER, THE BALLOON WOULD NOT ADVANCE OVER WIRE. THE DEVICE WAS REMOVED AND INSERTED A 2.5MM X 220MM X 150CM COYOTE BALLOON CATHETER BUT STILL IT WOULD NOT ADVANCE, AND THE WIRE FELT STICKY. THE WIRE AND BALLOON WERE REMOVED TOGETHER, HOWEVER, THE MIDDLE TO DISTAL PART OF THE WIRE COATING WAS SHEAR OFF AND THE BALLOON WAS KINKED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME BALLOON AND GUIDEWIRE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13742302 ↗
• MalfunctionMar 9, 2022Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT CATHETER BECAME STUCK ON THE GUIDEWIRE. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED ANTERIOR TIBIAL ARTERY. A 2MM X 40MM X 144CM COYOTE ES BALLOON CATHETER AND SAVION FLX GUIDEWIRE WERE SELECTED FOR USE. THE COYOTE BALLOON WAS ADVANCED FOR DILATION. HOWEVER, THE BALLOON BECAME STUCK ON THE SAVION FLX GUIDEWIRE AND THE BALLOON CATHETER BECAME KINKED. BOTH DEVICES WERE REMOVED TOGETHER AND THE PROCEDURE WAS COMPLETED WITH A NEW SAVION GUIDEWIRE AND COYOTE BALLOON. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13711424 ↗
• InjuryFeb 23, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT TIP DETACHMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND SEVERELY CALCIFIED PEDAL ARTERY (PA). A SAVION FLX GUIDEWIRE WAS ADVANCED TO GAIN ACCESS FROM THE FOOT UP TO THE PERONEAL ARTERY. HOWEVER, DURING THE PROCEDURE, A BIT OF RESISTANCE WAS FELT UPON ATTEMPTING TO ADVANCE THE DEVICE AND THE ENTIRE FLOPPY TIP OF THE GUIDEWIRE BROKE OFF IN PA AND WAS LEFT BEHIND. THE WIRE WAS REMOVED BUT THE TIP OF THE GUIDEWIRE HAD TO BE LEFT IN THE PATIENT'S FOOT DUE TO THE SIZE OF THE VESSEL AND NO DEVICE OR SNARE SMALL ENOUGH TO ATTEMPT A RETRIEVAL. THE PROCEDURE WAS COMPLETED WITH ANOTHER SAVION GUIDEWIRE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 13586585 ↗

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