Coyote™ H74939186351510Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729796749), received between Dec 2, 2025 and Dec 2, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Entrapment of Device” (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.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 2, 2025Entrapment of Device; Material Rupture; Entrapment of Device; Material Rupture

  IT WAS REPORTED THAT FROZE ON WIRE AND BALLOON RUPTURE OCCURRED. THE 70% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED POSTERIOR TIBIAL ARTERY OF THE RIGHT LOWER LIMB. A 014 X 300 CM NON-BOSTON SCIENTIFIC 014 GUIDEWIRE WAS USED TO CROSS THE LESION SUCCESSFULLY. AFTER GUIDEWIRE PLACEMENT, A 3.5 MM X 150 MM X 150 CM, OTW COYOTE BALLOON CATHETER WAS PREPARED AND ADVANCED OVER THE GUIDEWIRE WITHOUT DIFFICULTY. THE BALLOON WAS INFLATED AT THE LESION WITHOUT ISSUES. HOWEVER, RESISTANCE WAS ENCOUNTERED DURING WITHDRAWAL; THE BALLOON COULD NOT RETRACT OVER THE GUIDEWIRE AND HAD TO BE REMOVED TOGETHER AS A SINGLE UNIT, RESULTING IN LOSS OF ACCESS TO THE LESION. ONCE OUTSIDE THE PATIENT, ATTEMPTS TO SEPARATE THE BALLOON FROM THE GUIDEWIRE WERE UNSUCCESSFUL. BASED ON THE ATTACHED PHOTO, THE BALLOON WAS CONFIRMED TO HAVE RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THE PATIENTS CONDITION POST-PROCEDURE WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23698192 ↗