SAVION DLVR™ H749394203001J0Recalls & reported problems
Boston Scientific Corporation · Guidewire with ICE™ Hydrophilic coating · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729978862), received between Apr 23, 2019 and Jul 11, 2019 — classified as 1 injury, 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
Device problems
- Detachment of Device or Device Component2
- Entrapment of Device1
- Unraveled Material1
Patient problems
- Device Embedded In Tissue or Plaque1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJul 11, 2019Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE RADIOPAQUE TIP FELL OFF AND REMAINED INSIDE THE PATIENT. A SAVION DLVR WAS SELECTED FOR A SUPERFICIAL FEMORAL ARTERY (SFA)-POPLITEAL LOWER LEG ANGIOGRAM PROCEDURE. DURING THE PROCEDURE, THE PHYSICIAN WAS TRYING TO GET THROUGH A LESION IN THE SFA-POPLITEAL, WHILE USING A RUBICON DEVICE, AND THE WIRE SHREDDED. THE RADIOPAQUE TIP OF THE WIRE FELL OFF AND REMAINED INSIDE THE PATIENT. THEY WERE UNABLE TO RETRIEVE THE TIP OF THE WIRE AND IT IS STILL INSIDE THE PATIENT. THE CASE WAS ABORTED.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 8780803 ↗MalfunctionApr 23, 2019Entrapment of Device; Unraveled Material; Detachment of Device or Device Component; Entrapment of Device; Unraveled Material; Detachment of Device or Device Component
IT WAS REPORTED THAT THE WIRE BECAME STUCK IN THE LESION, AND ONCE REMOVED, THE TIP BROKE OFF INSIDE OF THE BALLOON. A SAVION DLVR GUIDEWIRE WAS SELECTED FOR A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE IN THE PATIENT'S RIGHT ANTERIOR TIBIAL ARTERY. THE LESION WAS A SUB TOTAL OCCLUDED ARTERY, AND HEAVILY CALCIFIED. THE PHYSICIAN WAS TRYING TO CROSS THE LESION WITH THE SAVION WIRE, BUT THE WIRE BECAME STUCK IN PLAQUE OR A PIECE OF CALCIUM. WHILE TRYING TO PULL THE WIRE OUT, THE TIP BECAME UNRAVELED. THE PHYSICIAN WAS ABLE TO GET IT LOOSE AND CAPTURE THE WIRE, BUT THE TIP BROKE OFF INSIDE OF AN UNSPECIFIED BALLOON. EVERYTHING WAS REMOVED TOGETHER AS A UNIT. NOTHING WAS LEFT BEHIND IN THE PATIENT. A DIFFERENT WIRE WAS USED TO CROSS THE LESION AND THEN A COYOTE WAS USED TO COMPLETE THE PROCEDURE. THE PATIENT TOLERATED EVERYTHING WELL. NO PATIENT COMPLICATIONS WERE REPORTED. THE PATIENT CONDITION AFTER THE PROCEDURE WAS FINE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8540755 ↗
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- PressureWire™ C12059Lightlab Imaging, Inc. · WIRE, GUIDE, CATHETER1 death296 reports
- SYNCHRO 2 M00326410Stryker Corporation · WIRE, GUIDE, CATHETER2 recalls155 reports
- ENROUTE .014" Guidewire 11686-01Silk Road Medical, Inc. · Wire, Guide, Catheter2 deaths228 reports
- ARROW IPN035915Teleflex Incorporated · WIRE, GUIDE, CATHETER217 reports
- OmniWire Pressure guide wire 89185Philips Image Guided Therapy Corporation · Wire, Guide, Catheter1 recall1 death160 reports
- ARROW IPN055780Teleflex Incorporated · Wire, guide, catheter4 recalls0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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