ChoICE™ H74912135011Recalls & reported problems
Boston Scientific Corporation · Guidewire with ICE™ Hydrophilic Coating · Class 2
All models of ChoICE (8)
Data updated Oct 18, 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 08714729252405), received between Nov 13, 2018 and Dec 3, 2018 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Material Integrity Problem” (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
- Adverse Event Without Identified Device or Use Problem1
- Material Integrity Problem1
Patient problems
- No Consequences Or Impact To Patient1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 3, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 12-NOV-2018. A 182CM CHOICE GUIDEWIRES WAS RECEIVED WITH NO ALLEGED ISSUE REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED COATING PEELED/SHEARED. DEVICE EVAL BY MANUFACTURER: THE DEVICE HAS ITS DISTAL TIP KINKED AND STRETCHED. THE PROXIMAL END AND THE BODY OF THE DEVICE ARE KINKED. THERE IS A SECTION OF THE COVER OF THE CORE WIRE THAT IS PEELED OFF, THIS AT THE DISTAL SECTION OF THE WIRE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8124983 ↗MalfunctionNov 13, 2018Material Integrity Problem; Material Integrity Problem
IT WAS REPORTED VIA VOLUNTARY MEDWATCH # MW5080210 THAT GUIDE WIRE COATING PEELED OFF. THE TARGET LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY. AFTER A GUIDE CATHETER WAS PLACED IN THE LESION, A 182CM CHOICE GUIDE WIRE WAS ADVANCED TO CROSS THE LESION. HOWEVER, THE WIRE ENDED UP GOING THROUGH ONE OF THE SIDE HOLES AND WHEN IT WAS RETRACTED, A PIECE OF THE WIRE COATING CAME OFF. THE WIRE AND GUIDE CATHETER WERE REMOVED AS ONE UNIT FROM THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8065352 ↗
Other WIRE, GUIDE, CATHETER devices
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- 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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