ChoICE™ PT H74912161011Recalls & 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
- 4
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08714729252528), received between Jan 21, 2021 and Jun 20, 2024 — classified as 2 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Break” (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
- Adverse Event Without Identified Device or Use Problem1
- Break1
- Detachment of Device or Device Component1
- Entrapment of Device1
- Material Integrity Problem1
Patient problems
- Device Embedded In Tissue or Plaque1
- Foreign Body In Patient1
- No Clinical Signs, Symptoms or Conditions1
- Perforation of Vessels1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 20, 2024Material Integrity Problem; Material Integrity Problem
IT WAS REPORTED THAT THE COATING WAS PEELING. A 182 CM CHOICE GUIDEWIRE WAS SELECTED FOR USE. DURING UNPACKING OF THE DEVICE, IT WAS NOTED THAT THE WIRE COATING WAS PEELING. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19578553 ↗InjuryDec 13, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED VIA MEDWATCH (B)(4) THAT TIP DETACHMENT OCCURRED. A CHOICE GUIDEWIRE WAS SELECTED FOR USE IN A CORONARY INTERVENTION PROCEDURE FOR A LESION IN THE LEFT MAIN. THE CHOICE GUIDEWIRE TIP SEPARATED WITHIN THE CORONARY ARTERY. ATTEMPTS WERE MADE TO RETRIEVE THE DETACHED TIP BUT WERE UNSUCCESSFUL. THE INTERVENTIONAL CARDIOLOGIST DETERMINED THAT THE DETACHED TIP COULD REMAIN WITHIN THE CORONARY VESSEL WITHOUT IT CAUSING HARM TO THE PATIENT. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: Foreign Body In Patient
MAUDE report 15970771 ↗MalfunctionDec 9, 2022Break; Entrapment of Device
THE INTERVENTIONAL WIRE IN THE PATIENT'S CORONARY ARTERY CAME APART AT THE RADIOPAQUE TO NON-RADIOPAQUE SECTION AND DOCTOR TRIED TO USE A SECOND WIRE TO LASSO THE WIRE, BUT UNSUCCESSFUL. DOCTOR REACHED OUT TO ANOTHER INTERVENTIONAL CARDIOLOGIST (DR. (B)(6)), AND DR. (B)(6) FELT AS IF NO ILL EFFECTS WOULD COME FROM JUST LEAVING THE WIRE TIP IN THE VESSEL. UPON CASE COMPLETION, DR. (B)(6) SPOKE WITH THE PATIENT REGARDING RESULTS AND THE WIRE TIP LEFT IN HIM.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 15949616 ↗InjuryJan 21, 2021Adverse 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 WITH LESS THAN 45 DEGREES BEND WAS LOCATED IN THE MODERATELY CALCIFIED AND MODERATELY TORTUOUS DISTAL CIRCUMFLEX ARTERY. A 182 CM CHOICE GUIDEWIRE WAS USED DURING THE PROCEDURE. HOWEVER, PERFORATION WAS NOTED DISTAL TO THE LESION. THE PROCEDURE WAS ABORTED, AND THE PHYSICIAN THEN PERFORMED PERICARDIOCENTESIS. THE PATIENT'S STATUS WAS STABLE.
Patient problems: Perforation of Vessels
MAUDE report 11206879 ↗
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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