ChoICE™ H7491213501J1Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 08714729252412), received between Jul 27, 2021 and Aug 18, 2025 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (4 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.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• 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 ↗
• 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 12233259 ↗
• MalfunctionJul 27, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT A 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 12233244 ↗