Coyote™ ES H74939134354010Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729767442), received between May 10, 2021 and Jul 10, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Difficult to Advance” (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.

• MalfunctionJul 10, 2024Difficult to Advance; Adverse Event Without Identified Device or Use Problem; Difficult to Advance; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON THE DEVICE ANALYSIS COMPLETED ON 18JUN2024. IT WAS REPORTED THAT THE BALLOON WOULD NOT LOAD INTO THE WIRE. THE TARGET LESION WAS LOCATED IN THE RIGHT LEG VESSEL. A 3.5MM X 40MM X 145CM COYOTE ES BALLOON CATHETER WAS SELECTED FOR USE. WHILE ATTEMPTING INSERTION, THE BALLOON FAILED TO LOAD ONTO THE WIRE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE THERE WERE NO PATIENT COMPLICATIONS REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED GUIDEWIRE LUMEN IS STRETCHED AND SEPARATED 7.8CM FROM THE TIP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19710071 ↗
• MalfunctionMay 10, 2021Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT CATHETER AND GUIDEWIRE ENTRAPMENT, PAIN AND ABORTED PROCEDURE OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY CALCIFIED DISTAL SUPERFICIAL FEMORAL ARTERY. A 3.5MM X 40MM X 145CM COYOTE ES BALLOON CATHETER WAS ADVANCED FOR DILATATION. THE BALLOON WAS DEPLOYED; HOWEVER, DURING WITHDRAWAL, THE PHYSICIAN COULD NOT REMOVE THE BALLOON OVER THE CHOICE GUIDEWIRE. THE BALLOON AND THE WIRE WERE ENTIRELY REMOVED AS ONE UNIT. THE PHYSICIAN DECIDED TO ABORT THE PROCEDURE BECAUSE THE PATIENT WAS HAVING SO MUCH BACK PAIN. NO PATIENT COMPLICATIONS WERE REPORTED. THE PATIENT WILL RETURN AT A LATER DATE TO BE TREATED WITH ATHERECTOMY.

  Patient problems: Pain

  MAUDE report 11797607 ↗