Marvel™ H749393013000Recalls & reported problems
Boston Scientific Corporation · Guidewire · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729887805), received between Jan 9, 2020 and Aug 14, 2024 — classified as 2 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Detachment of Device or Device Component1
- Material Integrity Problem1
Patient problems
- Foreign Body In Patient1
- Injury1
- Low Blood Pressure/ Hypotension1
- Respiratory Failure1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryAug 14, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT GUIDEWIRE DETACHMENT OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND CALCIFIED PROXIMAL ARTERY. A 300CM MARVEL GUIDEWIRE WAS ADVANCED AND ANGIOPLASTY AND STENTING WAS PERFORMED. UPON REMOVAL OF THE GUIDEWIRE, IT WAS NOTICED THAT THE DISTAL WIRE TIP WAS LEFT IN THE PROXIMAL ARTERY. ANOTHER STENT WAS IMPLANTED TO HOLD THE WIRE FRAGMENT INTO THE ARTERY WALL SO THAT IT WOULD NOT MIGRATE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND THERE WERE NO PATIENT COMPLICATIONS REPORTED.
Patient problems: Foreign Body In Patient
MAUDE report 19988496 ↗InjuryJan 9, 2020Material Integrity Problem; Material Integrity Problem
IT WAS REPORTED THAT PATIENT EXPERIENCED HYPOTENSION AND WIRE COATING PEELED OFF. THE TARGET LESION WAS LOCATED IN A CORONARY ARTERY. AFTER ADVANCING THE 300CM MARVEL GUIDEWIRE, A 3.00 X 20MM SYNERGY II DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, THE PATIENT EXPERIENCED LOW BLOOD PRESSURE. THE STENT WAS REMOVED AND THE WIRE WAS REPOSITIONED. IT WAS THEN NOTICED THAT THE STENT WAS UNABLE TO ADVANCE OVER THE WIRE AND THE TIP WAS DRAGGING THE COATING MATERIAL OFF THE WIRE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE AND NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: Injury; Low Blood Pressure/ Hypotension; Respiratory Failure
MAUDE report 9570730 ↗
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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