ChoICE™ PT H74912154011Recalls & 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
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729252467), received between Jun 7, 2022 and Oct 13, 2022 — classified as 2 injuries.
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
- Adverse Event Without Identified Device or Use Problem1
- Detachment of Device or Device Component1
- Device-Device Incompatibility1
Patient problems
- Foreign Body In Patient1
- Perforation1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryOct 13, 2022Detachment of Device or Device Component; Device-Device Incompatibility; Detachment of Device or Device Component; Device-Device Incompatibility
IT WAS REPORTED THAT TIP DETACHMENT OCCURRED, AND PROCEDURE WAS CANCELLED. THE TARGET LESION WAS LOCATED IN A SUPERFICIAL FEMORAL ARTERY. A 300CM (5PK) CHOICE PT GUIDEWIRE WAS INSERTED TO THE TARGET LESION. HOWEVER, DURING PROCEDURE, THE GUIDEWIRE BECAME LODGED BEHIND THE STENT THAT WAS PREVIOUSLY PLACED. WHEN THE GUIDEWIRE WAS REMOVED, THE DISTAL PART APPROXIMATELY 10 CM BROKE OFF AND REMAINED IN THE VESSEL. THE PHYSICIAN TRIED TO SNARE THE DETACHED COMPONENT BUT WAS UNSUCCESSFUL. THE TIP WAS LEFT INSIDE THE PATIENT'S BODY AND THE PHYSICIAN DECIDED TO STOP. THE PROCEDURE WAS NOT COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: Foreign Body In Patient
MAUDE report 15601130 ↗InjuryJun 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT VESSEL PERFORATION OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. A 300CM CHOICE PT GUIDEWIRE WAS SELECTED FOR USE. HOWEVER, DURING PROCEDURE, THE WIRE WAS ADVANCED ACCIDENTALLY TO VERY DISTAL LAD AND CAUSED A PERFORATION. AN ECHOCARDIOGRAM WAS PERFORMED TO RULE OUT PERICARDIAL EFFUSION AND A BALLOON WAS INFLATED PROXIMAL TO THE PERFORATION TO ALLOW IT TO SELF SEAL. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT STATUS WAS STABLE.
Patient problems: Perforation
MAUDE report 14623724 ↗
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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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