ChoICE™ H74912132011Recalls & 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
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08714729303022), received between Feb 17, 2022 and Jul 10, 2026 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Difficult to Remove” (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
- Difficult to Remove1
- Entrapment of Device1
- Failure to Advance1
- Fracture1
- Nonstandard Device1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Foreign Body In Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 10, 2026Nonstandard Device; Difficult to Remove; Failure to Advance
IT WAS REPORTED THAT THE DEVICE WAS DIFFICULT TO REMOVE. A CHOICE GUIDEWIRE WAS SELECTED AS PART OF TREATMENT OF THE TARGET LESION. DURING ADVANCEMENT, THE GUIDEWIRE EXPERIENCED DIFFICULTY CROSSING THE LESION. AFTER THE LESION HAD BEEN CROSSED, THE PHYSICIAN NOTED RESISTANCE AND STICKING WHEN WITHDRAWING THE GUIDEWIRE. THERE WERE NO PATIENT COMPLICATIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25785682 ↗InjuryMar 3, 2022Entrapment of Device; Entrapment of Device
IT WAS REPORTED VIA MEDWATCH (B)(4) THAT DEVICE ENTRAPMENT OCCURRED. AFTER STENT DEPLOYMENT, A 182CM (5PK) CHOICE GUIDEWIRE WAS ADVANCED, HOWEVER, THE WIRE WAS STUCK ON THE STENT. THE TEAM TRIED TO FREE THE WIRE FROM THE STENT BY USING AN ADD WIRE AND A NON-BOSTON SCIENTIFIC WIRE AND THE DOCTOR WAS ABLE TO TRAP IT AND PULL THE WIRE OUT. IT WAS NOTED THAT THERE WAS A PIECE OF THE WIRE STILL LEFT IN THE VESSEL. THE PROCEDURE WAS COMPLETED AND THERE WERE NO PATIENT COMPLICATIONS REPORTED.
Patient problems: Foreign Body In Patient
MAUDE report 13664874 ↗MalfunctionFeb 17, 2022Fracture; Fracture
IT WAS REPORTED THAT THE GUIDEWIRE HAD FRACTURED. A 182CM CHOICE FLOPPY GUIDEWIRE WAS BEING USED DURING A PERCUTANEOUS CORONARY INTERVENTION. DURING THE PROCEDURE, THE GUIDEWIRE BROKE. THE DEVICE WAS REMOVED FROM THE PATIENT, AND A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. NO PATIENT COMPLICATIONS OCCURRED DUE TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13549683 ↗
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- ENROUTE .014" Guidewire 11686-01Silk Road Medical, Inc. · Wire, Guide, Catheter2 deaths228 reports
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- 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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