ChoICE™ PT H7491215501J1Recalls & reported problems
Boston Scientific Corporation · Guidewire with ICE™ Hydrophilic Coating · Class 2
All models of ChoICE PT (6)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08714729252498), received between Feb 14, 2019 and Jul 30, 2025 — classified as 1 injury, 3 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (3 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Detachment of Device or Device Component3
- Adverse Event Without Identified Device or Use Problem1
- Entrapment of Device1
- Material Integrity Problem1
- Nonstandard Device1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 30, 2025Entrapment of Device; Nonstandard Device; Adverse Event Without Identified Device or Use Problem; Entrapment of Device; Nonstandard Device; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT GUIDEWIRE ENTRAPMENT OCCURRED. A CHOICE PT GUIDEWIRE WAS SELECTED FOR USE ALONG WITH A CAROTID WALLSTENT. THE STENT WAS SUCCESSFULLY DEPLOYED. WHEN THE USER ATTEMPTED TO REMOVE THE STENT DELIVERY SYSTEM FROM THE PATIENT, THE DELIVERY SYSTEM BECAME STUCK ON THE GUIDEWIRE. THE DELIVERY SYSTEM AND GUIDEWIRE WERE REMOVED AS ONE UNIT, AND THERE WERE NO PATIENT COMPLICATIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22668545 ↗MalfunctionOct 5, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT GUIDE WIRE TIP DETACHMENT OCCURRED. A 300 PT ES J CHOICE PT GUIDEWIRE WAS ADVANCED FOR TREATMENT. HOWEVER, DURING THE PROCEDURE, IT WAS NOTED THAT THE TIP AREA OF THE GUIDEWIRE WAS FRACTURED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15544967 ↗InjuryNov 15, 2021Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE GUIDEWIRE FRACTURE OCCURRED. A 300 PT ES J CHOICE GUIDEWIRE WAS ADVANCED, HOWEVER, DURING THE PROCEDURE THE GUIDEWIRE FRACTURE AT THE J-TIP PORTION. THE DETACHED PIECE WAS RETRIEVED USING AS SNARE AND COMPLETED THE PROCEDURE WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12815188 ↗MalfunctionFeb 14, 2019Detachment of Device or Device Component; Material Integrity Problem; Detachment of Device or Device Component; Material Integrity Problem
IT WAS REPORTED THAT TIP DETACHMENT OCCURRED. DURING UNPACKING OF A 300 PT ES J CHOICE PT GUIDEWIRE, IT WAS NOTED THAT THE TIP WAS BROKEN. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8341054 ↗
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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