Luge™ Magnet H7491213001MJ0Recalls & 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
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08714729895886), received between Oct 21, 2020 and Feb 24, 2023 — classified as 3 injuries.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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. 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 Component1
- Fracture1
- Material Twisted/Bent1
Patient problems
- Device Embedded In Tissue or Plaque1
- Foreign Body In Patient1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryFeb 24, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED VIA MEDWATCH ((B)(4)) THAT DISTAL TIP DETACHMENT OCCURRED. DURING A PERCUTANEOUS CORONARY INTERVENTION, A 182CM LUGE GUIDEWIRE WAS ADVANCED TO CROSS A LESION. HOWEVER, IT WAS NOTED THAT THE TIP OF GUIDEWIRE BROKE OFF AND WAS LEFT IN THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS DISCHARGED IN STABLE CONDITION.
Patient problems: Foreign Body In Patient
MAUDE report 16436371 ↗InjuryOct 29, 2020Material Twisted/Bent
DURING IMPLANTATION OF AICD, THE LUGE MAGNET GUIDEWIRE BECAME TANGLED INSIDE THE CORONARY SINUS VESSEL. WHILE MANEUVERING THE WIRE, THE TANGLED PART BROKE OFF FROM THE MAIN WIRE. FDA SAFETY REPORT ID# (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10762446 ↗InjuryOct 21, 2020Fracture; Fracture
IT WAS REPORTED THAT A GUIDEWIRE FRACTURE OCCURRED AND A PORTION OF THE DEVICE WAS LEFT IN THE PATIENT. A 182CM LUGE GUIDEWIRE WAS ADVANCED. HOWEVER, A SMALL PORTION OF THE WIRE BROKE OFF AND THE REST OF THE WIRE CAME BACK INTO THE NON-BSC SUPPORT CATHETER. THE PHYSICIAN DECIDED TO PROCEED AND COMPLETE PROCEDURE WITH THE DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED AND THE PATIENT REMAINED STABLE. THE PATIENT WAS DISCHARGED THE FOLLOWING DAY.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 10712074 ↗
Other WIRE, GUIDE, CATHETER devices
- HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II 1009664Abbott Vascular Inc. · WIRE, GUIDE, CATHETER321 reports
- SYNCHRO 14 M00313010Stryker Corporation · WIRE, GUIDE, CATHETER2 recalls220 reports
- 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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