Coyote™ ES H74939134404010Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08714729767473), received between Aug 20, 2018 and Apr 2, 2026 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (5 reports).

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 2, 2026Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS 95 -100% STENOSED, MODERATELY TORTUOUS AND SEVERELY CALCIFIED. A 2MM X 40MM X 144CM COYOTE ES WAS USED IN THE DISTAL TIBIAL ARTERY, A 4MM X 40MM X 145CM COYOTE ES WAS USED IN THE TIBIOPERONEAL ARTERY AND A 2.5X60X150 STERLING WAS USED IN THE MID TIBIAL ARTERY. DURING THE FIRST INFLATION AT 10 - 12 ATMOSPHERES FOR LESS THAN 20 SECONDS, THE BALLOON RUPTURED. THE BALLOON WAS REMOVED OVER THE WIRE THROUGH THE SHEATH, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24767290 ↗
• MalfunctionMar 24, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED POPLITEAL ARTERY. A 4MM X 40MM X 145CM COYOTE ES BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING FIRST INFLATION AT 12 ATMOSPHERES FOR 10 SECONDS, THE BALLOON BURST WITHOUT REACHING THE BURST RATED PRESSURE. THE BALLOON WAS REMOVED OVER THE WIRE AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21677216 ↗
• MalfunctionNov 19, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE ALMOST COMPLETELY BLOCKED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND SEVERELY CALCIFIED VESSEL. A 4MM X 40MM X 145CM COYOTE ES BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE INITIAL INFLATION AT 2 ATMOSPHERES FOR 1 SECOND, THE BALLOON RUPTURED. THE DEVICE WAS COMPLETELY REMOVED. A LASER DEVICE WAS USED TO FURTHER OPEN THE VESSEL AND THEN A STERLING BALLOON CATHETER WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20726360 ↗
• MalfunctionJun 27, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 4MM X 40MM X 145CM COYOTE ES BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING INFLATION, THE BALLOON RUPTURED. THE PROCEDURE WAS ENDED WITH NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8742380 ↗
• MalfunctionAug 20, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 4MM X 40MM X 145CM COYOTE ES BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, PRIOR TO FULL INFLATION THE BALLOON RUPTURED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7797805 ↗