Coyote™ H74939186201210Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08714729797159), received between Dec 8, 2020 and Apr 6, 2026 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (2 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 6, 2026Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN A MODERATELY TORTUOUS AND MODERATELY CALCIFIED VESSEL OF BELOW THE KNEE. A 2.0MM X 120MM X 150CM COYOTE BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE SECOND INFLATION AT 4 ATMOSPHERES FOR ABOUT A MINUTE, THE BALLOON RUPTURED. THE BALLOON WAS REMOVED SUCCESSFULLY FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24788744 ↗
• MalfunctionAug 12, 2024Inflation Problem; Material Rupture; Inflation Problem; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LOCATION WAS LOCATED IN THE MODERATE CALCIFIED VEIN. A 2.5MM X 150MM X 150CM COYOTE BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON DID NOT INFLATE AND WHEN EXPLANTED, A TEAR WAS NOTED. ANOTHER 2.0MM X 120MM X 150CM COYOTE BALLOON WAS USED AND IT BURST UPON SECOND INFLATION AT 6 ATMOSPHERES. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM, AND THE PROCEDURE WAS COMPLETED WITH ALTERNATIVE METHOD. NO PATIENT COMPLICATIONS WERE REPORTED. IT WAS FURTHER REVIEW REPORTED THE DEVICE WAS SIMPLY PULLED OUT AND THAT NO FRAGMENTS INSIDE THE PATIENT'S BODY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19960232 ↗
• MalfunctionMar 29, 2022Leak/Splash; Adverse Event Without Identified Device or Use Problem; Leak/Splash; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2022. IT WAS REPORTED THAT THE BALLOON HAD A LEAK. A COYOTE 2.0MM X 120MM X 150CM BALLOON CATHETER WAS SELECTED FOR USE TO TREAT BRUTON'S TYROSINE KINASE. THE PHYSICIAN INSERTED THE CATHETER, AND UPON TREATMENT THERE WAS A BALLOON LEAK. THE PROCEDURE WAS ABLE TO BE COMPLETED SUCCESSFULLY USING A NEW BALLOON WITHOUT SEQUELA. HOWEVER, DEVICE ANALYSIS REVEALED THE BALLOON WAS SEPARATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13942632 ↗
• MalfunctionDec 8, 2020Difficult to Remove; Adverse Event Without Identified Device or Use Problem; Difficult to Remove; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DIFFICULTY REMOVING A BALLOON OCCURRED. A LIMB SALVAGE CASE WAS PERFORMED ON A CALCIFIED VESSEL. A 2.00MM X 120MM X 150CM COYOTE BALLOON AND A V-14 CONTROL WIRE WERE DELIVERED THROUGH A 4FR SHEATH THROUGH THE CALCIFIED VESSEL. THE WIRE AND THE BALLOON BECAME STUCK AT THE DORSALIS PEDIS AND EXCESSIVE FORCE HAD TO BE USED TO REMOVE THE BALLOON AND THE WIRE, WHICH HAD BECOME STUCK TOGETHER. IT WAS NOTED THAT THERE WAS NO HARM TO THE PATIENT, BUT THE OPERATOR HAD INTENDED TO PROGRESS TREATMENT FURTHER INTO THE PLANTAR ARCH. THE CASE WAS ABANDONED AND NO FURTHER PRODUCTS WERE USED. NO PATIENT COMPLICATIONS RESULTED IN RELATION TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10969082 ↗