Coyote™ H74939186301210Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08714729796725), received between Nov 30, 2018 and May 26, 2025 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Break” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 26, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE ANTERIOR TIBIAL ARTERY. A 3.0MM X 120MM X 150CM COYOTE BALLOON CATHETER WAS ADVANCED FOR DILATATION. DURING INFLATION, THE BALLOON BURST BEFORE IT REACHED THE NORMAL BURST PRESSURE (NBP). THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE TARGET LESION WAS 100% STENOSED, SEVERELY TORTUOUS AND NON-CALCIFIED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22084721 ↗
• MalfunctionJan 23, 2025Failure to Deflate; Failure to Deflate

  IT WAS REPORTED THAT DEFLATION ISSUE OCCURRED. THE PATIENT PRESENTED WITH A NON-HEALING WOUND AND UNDERWENT PERIPHERAL ANGIOGRAM. A 3.0MM X 120MM X 150CM, OTW COYOTE BALLOON CATHETER WAS ADVANCED INTO THE PROXIMAL RIGHT ANTERIOR TIBIAL (AT) ARTERY AND WAS INFLATED TO 10 ATMOSPHERES USING A MIXTURE OF 70% SALINE AND 30% CONTRAST. HOWEVER, DURING REMOVAL, THE PROXIMAL HALF OF THE BALLOON DID NOT DEFLATE DESPITE SEVERAL ATTEMPTS. PULLED NEGATIVE ON THE BALLOON WITH AN EMPTY 10CC SYRINGE, AND ADDED MORE SALINE BUT THE BALLOON WOULD STILL NOT FULLY DEFLATE. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21223778 ↗
• MalfunctionApr 23, 2019Break; Entrapment of Device; Physical Resistance/Sticking; Break; Entrapment of Device; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE BALLOON BECAME STUCK WITH THE WIRE AND THEN PEELED AWAY FROM THE WIRE. A COYOTE BALLOON WAS SELECTED FOR AN ARTERIAL PROCEDURE. WHILE LOADING BALLOON ON TO THE WIRE IT WAS STICKING, BUT THEY MANAGED TO USE IT FOR THE CASE. HOWEVER, WHEN THEY TRIED TO REMOVE IT OFF OF THE WIRE, IT WAS STUCK. IT THEN PEELED AWAY FROM THE WIRE WHILE REMOVING IT FROM INSIDE OF THE PATIENT. THIS WAS THE ONLY WAY THEY WERE ABLE TO REMOVE IT. PATIENT WAS FINE. ANOTHER OF THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE PATIENT CONDITION AFTER THE PROCEDURE WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8541273 ↗
• MalfunctionNov 30, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT BALLOON DETACHMENT OCCURRED. A 3.0MM X 120MM X 150CM COYOTE BALLOON CATHETER WAS SELECTED FOR USE; HOWEVER, WHEN THE DEVICE WAS REMOVED FROM THE STERILE PACKAGING, IT WAS NOTED THAT THE BALLOON MATERIAL WAS BROKEN. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 8121293 ↗