Platinum Plus™ M001467310Recalls & reported problems
Boston Scientific Corporation · Guidewire with Glidex™ Hydrophilic coating · Class 2
All models of Platinum Plus (10)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729326205), received between Apr 3, 2018 and Aug 24, 2022 — classified as 2 malfunctions.
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.
Most reported problems
Device problems
- Detachment of Device or Device Component1
- Stretched1
- Unraveled Material1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Patient Involvement1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 24, 2022Stretched; Detachment of Device or Device Component; Stretched; Detachment of Device or Device Component
IT WAS REPORTED THAT THE GUIDEWIRE DETACHED. A 018/180CM PLATINUM PLUS GUIDEWIRE WAS SELECTED FOR USE IN THE 90% STENOSED, MODERATELY TORTUOUS AND CALCIFIED, SUPERFICIAL FEMORAL ARTERY. HOWEVER, IT WAS NOTED THAT DURING THE PROCEDURE THE GUIDEWIRE WAS STRETCHED AND SEPARATED. THE GUIDEWIRE WAS SIMPLY PULLED OUT AND ANOTHER GUIDEWIRE WAS USED. THERE WERE NO PATIENT COMPLICATIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15285673 ↗MalfunctionApr 3, 2018Unraveled Material
REMOVED 0.18 PLATINUM PLUS WIRE FROM PACKAGING TO FIND FLOPPY TIP OF WIRE HAD BECOME UNWOUND AND APPEARED TO BE ON THE VERGE OF BREAKING. WIRE WAS REMOVED FROM SERVICE AND WAS NOT USED ON THE PATIENT.
Patient problems: No Patient Involvement
MAUDE report 7395587 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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