PT Graphix™ H7491491401J1Recalls & reported problems
Boston Scientific Corporation · Guidewire with ICE™ Hydrophilic Coating · Class 2
All models of PT Graphix (6)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729255024), received between Feb 16, 2024 and Feb 16, 2024 — classified as 1 injury.
The most frequently reported specific device problem is “Fracture” (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
- Fracture1
Patient problems
- Foreign Body In Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryFeb 16, 2024Fracture; Fracture
IT WAS REPORTED THAT THE COATING PEELED REQUIRING INTERVENTION. THE 40% STENOSED TARGET LESION WAS LOCATED IN THE SLIGHTLY TORTUOUS LEFT POPLITEAL ARTERY/TIBIA PERONEAL TRUNK ARTERY. A 300CM PTGRAPHIX GUIDEWIRE WAS ADVANCE TO CROSS THE LESION. HOWEVER, DURING THE PROCEDURE, THE HYDROPHILIC COATING CAME OFF INSIDE THE PATIENT. THE FRAGMENT WAS NOT ABLE TO BE RETRIEVED, AND ANGIOPLASTY WAS PERFORMED TO PUSH THE HYDROPHILIC COATING OUT OF THE WAY. THE DEVICE FRAGMENT WAS LEFT INSIDE THE PATIENT'S BODY, AND THE PROCEDURE WAS COMPLETED USING AN ALTERNATE DEVICE. NO PATIENT HARM WAS REPORTED.
Patient problems: Foreign Body In Patient
MAUDE report 18725070 ↗
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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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