Coyote™ H74939186301590Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729797258), received between Jul 30, 2019 and Jul 30, 2019 — classified as 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 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.

• MalfunctionJul 30, 2019Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT BALLOON DEFLATION SLOW OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND MODERATELY CALCIFIED ANTERIOR TIBIAL ARTERY. AN ENCORE 26 INFLATION SYRINGE WAS USED TO INFLATE A 3.00MM X 150MM X 90CM COYOTE BALLOON CATHETER. THE BALLOON WAS INFLATED AND DEFLATED TWICE AND REMOVED FROM THE PATIENT. ON THE THIRD INFLATION, THE BALLOON INFLATED FINE BUT WHEN THE PHYSICIAN WENT TO DEFLATE THE BALLOON IT WAS VERY SLOW TO DEFLATE. THE PHYSICIAN FILLED THEY SYRINGE WITH MORE SALINE AND INFLATED THE BALLOON A BIT MORE, BUT DEFLATION WAS STILL SLOW. THE PHYSICIAN THEN PULLED BACK ON THE BALLOON A LITTLE TO STRAIGHTEN THE BALLOON AND THE BALLOON SUDDENLY DEFLATED. THE PROCEDURE WAS COMPLETED AS PLANNED USING THE DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8842866 ↗