ChoICERecalls & reported problems across all models

We found 8 models of ChoICE by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 29 adverse event reports in the FDA's MAUDE database, received between Nov 13, 2018 and Aug 6, 2026 — classified as 1 death, 8 injuries, 20 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (15 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported ChoICE problems

ChoICE models

8 models, most reported first. Each model has its own page with its reports, recalls and device details.

• ChoICE™ H7491213201J1

  WIRE, GUIDE, CATHETER
  10 reports
• ChoICE™ H7491213501J1

  WIRE, GUIDE, CATHETER
  6 reports
• ChoICE™ H7491211901J1

  WIRE, GUIDE, CATHETER
  3 reports
• ChoICE™ H74912133011

  WIRE, GUIDE, CATHETER
  1 death3 reports
• ChoICE™ H74912132011

  WIRE, GUIDE, CATHETER
  3 reports
• ChoICE™ H74912135011

  WIRE, GUIDE, CATHETER
  2 reports
• ChoICE™ H74912119011

  WIRE, GUIDE, CATHETER
  1 report
• ChoICE™ H7491213301J1

  WIRE, GUIDE, CATHETER
  1 report

Recent ChoICE adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionAug 6, 2026Nonstandard Device; Difficult to Remove

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50162963 ↗
• 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 ↗
• MalfunctionAug 18, 2025Unraveled Material; Material Integrity Problem; Unraveled Material; Material Integrity Problem

  IT WAS REPORTED THAT COATING ISSUE OCCURRED. A 182CM CHOICE GUIDEWIRE WAS SELECTED FOR USE. HOWEVER, IT WAS NOTED THAT THE GUIDEWIRE HAD AN EXPOSED PORTION OF THE RADIOPAQUE PART OF THE DEVICE CAUSES DISCONTINUITY IN COVERING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22834358 ↗
• MalfunctionJun 17, 2025Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT GUIDE WIRE TIP DETACHMENT OCCURRED. A 182CM CHOICE GUIDEWIRE WAS SELECTED FOR USE. HOWEVER, UPON OPENING, AN ANOMALY WAS OBSERVED IN ITS STRUCTURE, AND IT WAS NOTED THAT THE FLEXIBLE TIP WAS REMOVED. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22248132 ↗
• DeathJul 15, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE DEVICE DETACHED AND THE PATIENT DIED. THE PATIENT PRESENTED WITH CORONARY ARTERY DISEASE. DURING PERCUTANEOUS INTERVENTION, A 182CM CHOICE GUIDEWIRE WAS ADVANCED AND THE TIP OF THE GUIDEWIRE BROKE OFF IN THE CIRCUMFLEX ARTERY. INSTEAD OF REMOVING THE 6MM DEVICE FRAGMENT, THE PHYSICIAN DECIDED TO PRESS A PORTION OF THE GUIDEWIRE TIP TO THE VESSEL WALL USING A STENT. THE ENTIRE LENGTH OF THE DEVICE FRAGMENT COULD NOT BE STENTED TO THE VESSEL WALL. THE PATIENT REMAINED STABLE DURING THE PROCEDURE. THE FOLLOWING DAY, DIAGNOSTIC CORONARY ANGIOGRAPHY REVEALED THAT THE LUMEN OF THE ARTERY WAS NORMAL, BLOOD FLOW WAS NOT LIMITED. THE PATIENT WAS TRANSFERRED TO ANOTHER HOSPITAL FOR ADDITIONAL INTERVENTION. TWO ADDITIONAL STENTS WERE DEPLOYED IN THE CIRCUMFLEX PRESSING THE REMAINDER OF THE GUIDEWIRE TIP AGAINST THE VESSEL WALL. THROMBOSIS THEN OCCURRED RESULTING IN THE DEATH OF THE PATIENT.

  Patient problems: Foreign Body In Patient; Thrombosis/Thrombus

  MAUDE report 19745390 ↗
• MalfunctionMar 12, 2024Fracture; Fracture

  IT WAS REPORTED THAT GUIDEWIRE FRACTURE OCCURRED. A 182CM CHOICE GUIDEWIRE WAS SELECTED FOR USE. HOWEVER, IT WAS FOUND THAT THE DEVICE WAS FRACTURED WHEN REMOVING IT FROM ITS PACKAGING. THE PROCEDURE WAS COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18887818 ↗
• 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 ↗
• MalfunctionJun 29, 2023Detachment of Device or Device Component; Positioning Problem; Detachment of Device or Device Component; Positioning Problem

  IT WAS REPORTED THAT GUIDEWIRE TIP DETACHMENT OCCURRED. THE PATIENT PRESENTED WITH SEVERE DISEASE OF THE RIGHT CORONARY ARTERY AND UNDERWENT CORONARY ANGIOPLASTY. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED RIGHT CORONARY ARTERY. A182CM CHOICE GUIDEWIRE WAS CROSSED THE LESION. HOWEVER, DURING INSERTION, THERE WAS POOR TORQUE RESPONSE AND THE TIP GUIDEWIRE WAS FRACTURED. THE DEVICE WAS REMOVED COMPLETELY AND INTACT. THE PROCEDURE WAS COMPLETED WITH A NEW CHOICE GUIDEWIRE THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED, AND THE PATIENT CONDITION WAS GOOD POST-PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17233683 ↗
• MalfunctionJul 25, 2022Failure to Advance; Material Integrity Problem; Failure to Advance; Material Integrity Problem

  IT WAS REPORTED THAT COATING ISSUE OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND NON-CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 182CM (5PK) CHOICE GUIDEWIRE WAS SELECTED FOR USE. HOWEVER, RESISTANCE WAS ENCOUNTERED WHEN THE DEVICE WAS TRIED TO CROSS THE LESION AND THE TIP OF THE WIRE WAS PEELED OFF. THE PROCEDURE WAS COMPLETED WITH ANOTHER WIRE OF SAME BRAND. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15094893 ↗
• InjuryJul 21, 2022Difficult to Advance; Difficult to Advance

  IT WAS REPORTED THAT VESSEL DISSECTION, HYPOTENSION, AND CARDIAC ARREST OCCURRED REQUIRING SURGERY TO RESOLVE. THE PATIENT PRESENTED FOR A PROCEDURE TO IMPLANT A CARDIORESYNCHRONIZER. FOLLOWING CANNULATION OF THE CORONARY SINUS, A 182CM CHOICE GUIDEWIRE WAS INTRODUCED. AS THE GUIDEWIRE WAS BEING ADVANCED, RESISTANCE WAS ENCOUNTERED AND A DISSECTION OF THE CORONARY SINUS WAS NOTED. THE PATIENT THEN EXPERIENCED HYPOTENSION AND CARDIAC ARREST. THE PATIENT WAS RESUSCITATED AND PERICARDIOCENTESIS WAS PERFORMED. THE PATIENT WAS TRANSFERRED URGENTLY TO THE OPERATING ROOM WHERE THE BLEEDING WAS CONTROLLED. AN EPICARDIAL LEFT VENTRICULAR (LV) ELECTRODE WAS IMPLANTED AND THE PATIENT IS EXPECTED TO FULLY RECOVER.

  Patient problems: Cardiac Arrest; Cardiac Tamponade; Low Blood Pressure/ Hypotension; Vascular Dissection

  MAUDE report 15080079 ↗
• 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 ↗
• 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 ↗

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