ChoICE™ H74912133011Recalls & reported problems
Boston Scientific Corporation · Guidewire with ICE™ Hydrophilic Coating · Class 2
All models of ChoICE (8)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 1
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08714729252368), received between Jul 25, 2022 and Aug 6, 2026 — classified as 1 death, 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.
Reports received per month
Most reported problems
Device problems
- Detachment of Device or Device Component1
- Difficult to Remove1
- Failure to Advance1
- Material Integrity Problem1
- Nonstandard Device1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Foreign Body In Patient1
- Thrombosis/Thrombus1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 6, 2026Nonstandard Device; Difficult to Remove
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50162963 ↗DeathJul 15, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE DEVICE DETACHED AND THE PATIENT DIED. THE PATIENT PRESENTED WITH CORONARY ARTERY DISEASE. DURING PERCUTANEOUS INTERVENTION, A 182CM CHOICE GUIDEWIRE WAS ADVANCED AND THE TIP OF THE GUIDEWIRE BROKE OFF IN THE CIRCUMFLEX ARTERY. INSTEAD OF REMOVING THE 6MM DEVICE FRAGMENT, THE PHYSICIAN DECIDED TO PRESS A PORTION OF THE GUIDEWIRE TIP TO THE VESSEL WALL USING A STENT. THE ENTIRE LENGTH OF THE DEVICE FRAGMENT COULD NOT BE STENTED TO THE VESSEL WALL. THE PATIENT REMAINED STABLE DURING THE PROCEDURE. THE FOLLOWING DAY, DIAGNOSTIC CORONARY ANGIOGRAPHY REVEALED THAT THE LUMEN OF THE ARTERY WAS NORMAL, BLOOD FLOW WAS NOT LIMITED. THE PATIENT WAS TRANSFERRED TO ANOTHER HOSPITAL FOR ADDITIONAL INTERVENTION. TWO ADDITIONAL STENTS WERE DEPLOYED IN THE CIRCUMFLEX PRESSING THE REMAINDER OF THE GUIDEWIRE TIP AGAINST THE VESSEL WALL. THROMBOSIS THEN OCCURRED RESULTING IN THE DEATH OF THE PATIENT.
Patient problems: Foreign Body In Patient; Thrombosis/Thrombus
MAUDE report 19745390 ↗MalfunctionJul 25, 2022Failure to Advance; Material Integrity Problem; Failure to Advance; Material Integrity Problem
IT WAS REPORTED THAT COATING ISSUE OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND NON-CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 182CM (5PK) CHOICE GUIDEWIRE WAS SELECTED FOR USE. HOWEVER, RESISTANCE WAS ENCOUNTERED WHEN THE DEVICE WAS TRIED TO CROSS THE LESION AND THE TIP OF THE WIRE WAS PEELED OFF. THE PROCEDURE WAS COMPLETED WITH ANOTHER WIRE OF SAME BRAND. THERE WERE NO PATIENT COMPLICATIONS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15094893 ↗
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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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