ChoICE™ H7491211901J1Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08714729252290), received between Jul 26, 2019 and Nov 7, 2019 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 7, 2019Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT A CATHETER AND GUIDEWIRE ENTRAPMENT OCCURRED. AFTER A 300 ES J CHOICE GUIDEWIRE CROSSED THE LESION, A 10.0-31 CAROTID WALLSTENT WAS ADVANCED FOR TREATMENT. HOWEVER, WHEN THE STENT WAS ATTEMPTED TO BE RELEASED, IT WAS NOTED THAT THE GUIDEWIRE STUCK WITHIN THE STENT SYSTEM AND COULD NOT BE RELEASED. THE WALLSTENT DELIVERY SYSTEM AND THE CHOICE GUIDEWIRE WERE REMOVED TOGETHER AND THE PROCEDURE WAS COMPLETED WITH ANOTHER WALLSTENT AND ANOTHER GUIDEWIRE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED AND THE PATIENT'S CONDITION WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9291578 ↗
• MalfunctionJul 26, 2019Break; Detachment of Device or Device Component

  DURING PCI OF THE CIRCUMFLEX ARTERY, WHILE PHYSICIAN WAS ATTEMPTING TO PLACE PCI WIRE ACROSS THE STENOTIC LESION THE PROXIMAL FLEXIBLE PORTION OF THE WIRE TIP BROKE OFF AND REMAINED IN THE CIRCUMFLEX ARTERY. MULTIPLE ATTEMPTS WERE MADE TO RETRIEVE THE BROKEN WIRE FROM THE VESSEL BUT ALL FAILED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8836435 ↗
• InjuryJul 26, 2019Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component

  IT WAS REPORTED THAT GUIDE WIRE TIP DETACHMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT CIRCUMFLEX CORONARY ARTERY. A 300CM J CHOICE EXTRA SUPPORT GUIDEWIRE WAS ADVANCED TO CROSS THE LESION. HOWEVER, IT WAS NOTED THAT BALLOON COULD NOT PASS ACROSS THAT WIRE. PHYSICIAN WANTED TO USE A DIFFERENT WIRE AND PULLED THE WIRE OUT. WHEN DEVICE WAS REMOVED, IT WAS NOTED THAT THE WIRE CAUGHT IN THE VESSEL AND THE TIP PORTION WAS FRACTURED AND BROKE OFF INSIDE THE PATIENT. THE PHYSICIAN PULLED THE REST OF THE REMAINING OF THE WIRE OUT, BUT PART OF THE WIRE STILL STAYED INSIDE THE PATIENT. AN ATTEMPT TO SNARE THE DETACHED PART OF THE TIP WAS DONE, BUT IT WAS UNSUCCESSFUL. THE DETACHED PART OF THE TIP WAS LEFT INSIDE THE PATIENT'S BODY. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8831502 ↗