ChoICE™ H7491213201J1Recalls & 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
- 10
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 08714729252351), received between Aug 21, 2019 and Feb 2, 2024 — classified as 4 injuries, 6 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (7 reports).
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 Component7
- Fracture3
- Device-Device Incompatibility1
- Difficult to Remove1
- Entrapment of Device1
- Use of Device Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions6
- Device Embedded In Tissue or Plaque2
- Foreign Body In Patient1
- No Patient Involvement1
Recent adverse event reports
The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 2, 2024Fracture; Fracture
IT WAS REPORTED THAT THE DEVICE FRACTURED. UPON OPENING THE PACKAGE, A CHOICE GUIDEWIRE APPEARED "FRAYED." THE DEVICE WAS NOT USED FOR THE PROCEDURE. NO PATIENT CONTACT OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18634330 ↗MalfunctionFeb 2, 2024Fracture; Fracture
IT WAS REPORTED THAT THE DEVICE FRACTURED. UPON OPENING THE PACKAGE, A CHOICE GUIDEWIRE APPEARED "FRAYED." THE DEVICE WAS NOT USED FOR THE PROCEDURE. NO PATIENT CONTACT OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18634261 ↗InjuryFeb 2, 2024Detachment of Device or Device Component; Device-Device Incompatibility; Detachment of Device or Device Component; Device-Device Incompatibility
IT WAS REPORTED THAT THE DEVICE DETACHED REQUIRING ADDITIONAL INTERVENTION. A CHOICE GUIDEWIRE WAS ADVANCED AND BECAME STUCK UNDER A STENT. DURING ATTEMPTED REMOVAL, THE GUIDEWIRE "FRAYED" AND BROKE. THE GUIDEWIRE IS BROKEN IN THE PATIENT. THREE STENTS WERE PLACED CRUSHING THE DISTAL STENT.
Patient problems: Foreign Body In Patient
MAUDE report 18632603 ↗MalfunctionNov 16, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT DISTAL TIP FRACTURE OCCURRED. DURING PREPARATION OF A 182CM J CHOICE FLOPPY GUIDEWIRE, THE TIP WAS FOUND TO BE FRACTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18152169 ↗InjuryJun 16, 2022Use of Device Problem; Detachment of Device or Device Component; Use of Device Problem; Detachment of Device or Device Component
IT WAS REPORTED THAT DISTAL TIP DETACHMENT OCCURRED. A 182CM J (5PK) CHOICE GUIDEWIRE WAS USED IN A RIGHT HEART CATHERIZATION PROCEDURE. HOWEVER, IT WAS NOTED THAT THE RADIOPAQUE PORTION OF THE WIRE BROKE OFF. THE DETACHED PORTION WAS SUCCESSFULLY SNARED AND REMOVED FROM THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14716812 ↗MalfunctionFeb 23, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT GUIDEWIRE DETACHMENT OCCURRED. THE PATIENT PRESENTED WITH CORONARY ARTERIAL OCCLUSION. A 182CM J CHOICE GUIDEWIRE WAS SELECTED FOR USE. HOWEVER, DURING INTRODUCTION, THE DEVICE WAS FRACTURED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT GUIDEWIRE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13588882 ↗MalfunctionJul 27, 2021Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT GUIDEWIRE TIP DETACHMENT OCCURRED. A 182CM J CHOICE GUIDEWIRE WAS SELECTED FOR USE; HOWEVER, UPON REMOVAL FROM THE PROTECTIVE CASE, IT WAS NOTICED THAT THE GUIDEWIRE TIP WAS DAMAGED AND BROKEN. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS WAS STABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12233197 ↗InjuryDec 11, 2019Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component
IT WAS REPORTED THAT DETACHMENT OF DEVICE OCCURRED. THE TARGET LESION WAS LOCATED IN THE CORONARY ARTERY. A FLOPPY 182CM J CHOICE GUIDEWIRE WAS USED FOR TREATMENT. HOWEVER, DURING PROCEDURE, ENTRAPMENT OCCURRED WHEN REMOVING THE DEVICE. THE GUIDEWIRE TIP FRACTURE REMAINED INSIDE THE PATIENT'S BODY.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 9450499 ↗InjuryDec 9, 2019Entrapment of Device; Detachment of Device or Device Component; Entrapment of Device; Detachment of Device or Device Component
IT WAS REPORTED THAT DETACHMENT OF DEVICE OCCURRED. THE TARGET LESION WAS LOCATED IN THE CORONARY ARTERY. A FLOPPY 182CM J CHOICE GUIDEWIRE WAS USED FOR TREATMENT. HOWEVER, DURING PROCEDURE, ENTRAPMENT OCCURRED WHEN REMOVING THE DEVICE. THE GUIDEWIRE TIP FRACTURE REMAINED INSIDE THE PATIENT'S BODY.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 9438400 ↗MalfunctionAug 21, 2019Fracture; Fracture
IT WAS REPORTED THAT GUIDE WIRE TIP FRACTURE OCCURRED. DURING UNPACKING OF A 182CM CHOICE GUIDE WIRE, A FRACTURE OF THE TIP WAS NOTED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: No Patient Involvement
MAUDE report 8914640 ↗
Other WIRE, GUIDE, CATHETER devices
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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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