ChoICE™ PT H74912160011Recalls & reported problems
Boston Scientific Corporation · Guidewire with ICE™ Hydrophilic Coating · Class 2
All models of ChoICE PT (6)
Data updated Oct 18, 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 08714729252504), received between Jul 22, 2025 and Jul 22, 2025 — classified as 1 injury.
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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Detachment of Device or Device Component1
- Device-Device Incompatibility1
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.
InjuryJul 22, 2025Detachment of Device or Device Component; Device-Device Incompatibility; Detachment of Device or Device Component; Device-Device Incompatibility
IT WAS REPORTED THAT GUIDEWIRE DETACHMENT AND UNRETRIEVED DEVICE FRAGMENT OCCURRED. THE PATIENT UNDERWENT PERCUTANEOUS CORONARY INTERVENTION (PCI). THE TARGET LESION WAS LOCATED IN THE MID-LEFT ANTERIOR DESCENDING (LAD) ARTERY AND THE DIAGONAL BRANCH. UNKNOWN STENTS WERE DELIVERED TO THE MID-LAD AND DIAGONAL 2. DURING THE ATTEMPT TO RE-WIRE THE DIAGONAL 2 WITH A 182CM CHOICE GUIDEWIRE, THE GUIDEWIRE BECAME WEDGED UNDER A STENT AND COULD NOT BE WITHDRAWN. AN UNKNOWN BALLOON CATHETER WAS THEN ADVANCED IN AN ATTEMPT TO REMOVE THE WIRE SUCCESSFULLY. THE TIP OF THE GUIDEWIRE BROKE OFF AND REMAINED IN THE DIAGONAL 2 WITH SOME OF IT IN THE MID-LAD. FLOW WAS PRESERVED AT TIMI-3 GRADE, AND THE PATIENT REMAINED ASYMPTOMATIC. NO FURTHER ISSUES WERE REPORTED AS A RESULTS OF THIS EVENT.
Patient problems: Foreign Body In Patient
MAUDE report 22572171 ↗
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- 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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