Coyote™ H74939186300690Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729797234), received between Feb 12, 2020 and Mar 18, 2024 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Deflation Problem” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMar 18, 2024Entrapment of Device; Detachment of Device or Device Component; Entrapment of Device; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE BALLOON WAS ENTRAPPED ON THE GUIDEWIRE. THE 80% TARGET LESION WAS LOCATED IN THE MODERATELY TO SEVERELY TORTUOUS AND SEVERELY CALCIFIED VESSEL IN THE LOWER LEG. A 3.0MM X 60MM X 90CM COYOTE BALLOON CATHETER WAS ADVANCED FOR DILATATION. DURING DEVICE REMOVAL, DIFFICULTIES WERE ENCOUNTERED WITH THE 0.014 NON-BOSTON SCIENTIFIC GUIDEWIRE. THEY TRIED MULTIPLE WAYS TO RETRIEVE THE DEVICE AND HAD BOTH DEVICES REMOVED TOGETHER. IT WAS THEN NOTED THAT THE YELLOW END TIP CAME OFF AND WENT MISSING. NO COMPLICATIONS WERE REPORTED. IT WAS FURTHER REPORTED THAT THE YELLOW END TIP OF THE BALLOON HAS FALLEN OFF AND WAS LEFT INSIDE THE PATIENT DUE TO THE HIGH DEGREE OF STENOSIS AND CALCIFICATION OF THE ANATOMY AND ONLY DISCOVERED MISSING UPON REMOVAL.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18924471 ↗
• MalfunctionFeb 12, 2020Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT BALLOON DEFLATION ISSUES OCCURRED. THE TARGET LESION WAS LOCATED IN THE TIBIAL ARTERY. THIS 3.0MM X 60MM X 90CM COYOTE BALLOON CATHETER WAS ADVANCED TO THE TARGET LESION AND INFLATED. HOWEVER, THE BALLOON WOULD NOT DEFLATE AND HAD DO BE WITHDRAWN FROM THE PATIENT INFLATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9699453 ↗