Coyote™ H74939186401010Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08714729797364), received between Feb 15, 2022 and Sep 12, 2025 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (3 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 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.

• MalfunctionSep 12, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. 4.0MM X 100MM X 150CM COYOTE BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING PROCEDURE THE BALLOON BURST DURING INFLATION WITHOUT REACHING THE BURST RATED PRESSURE. THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE PATIENT WAS TREATED FOR A PERIPHERAL ARTERIAL DISEASE AT THE SUPERFICIAL FEMORAL ARTERY (SFA) FOR THE STERLING BALLOON AND TIBIAL ARTERY FOR THE COYOTE. THE TARGET LESION WAS APPROXIMATELY ABOVE 90% STENOSIS, NOT TORTUOUS, AND MODERATELY TO SEVERELY CALCIFIED. THE BALLOON RUPTURED AT THE FIRST INFLATION WHILE TAKING THE IT UP AT BELOW BURST PRESSURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23041763 ↗
• MalfunctionJul 11, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE TIBIAL ARTERY. A 4.0MM X 100MM X 150CM COYOTE OTW BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING FIRST INFLATION WITHOUT REACHING THE RATED BURST PRESSURE, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED IN ONE PIECE, AND THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE COYOTE BALLOON CATHETER. NO PATIENT COMPLICATIONS REPORTED, AND THE PATIENT CONDITION WAS STABLE POST-PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22482070 ↗
• InjuryOct 29, 2024Entrapment of Device; Inflation Problem; Material Twisted/Bent; Failure to Deflate; Entrapment of Device; Inflation Problem; Material Twisted/Bent; Failure to Deflate

  IT WAS REPORTED THAT THE BALLOON DEFLATION ISSUE OCCURRED REQUIRING ADDITIONAL INTERVENTION, AND BALLOON BECAME STUCK WITH THE WIRE. THE MORE THAN 50% STENOSED, 100 MM X 6 MM, STRAIGHT AND FOCAL TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND NON-CALCIFIED VESSEL. A 4.0MM X 100MM X 150CM COYOTE BALLOON CATHETER WAS ADVANCED FOR DILATATION. DURING THE PROCEDURE, UPON INFLATION TO 6 ATMOSPHERES. THE BALLOON WOULD NOT INFLATE INITIALLY. THE BALLOON WAS DEFLATED AND UPON SECOND INFLATION, THE BALLOON WOULD ONLY PARTIALLY INFLATE. THEN THE BALLOON WOULD NOT DEFLATE WITH INFLATING DEVICE. A LARGER SYRINGE WAS USED TO DEFLATE. WHEN ATTEMPTING TO GET THE BALLOON TO COME BACK DOWN THE WIRE, THE BALLOON WOULD NOT ADVANCE IN EITHER DIRECTION. THE BALLOON WAS ATTEMPTED TO PULL BACK AGAIN; HOWEVER, THE WIRE BROKE FROM TENSION AND THE BALLOON HAD NOT MOVED. BOTH THE WIRE AND BALLOON WERE REMOVED TOGETHER. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20560978 ↗
• MalfunctionFeb 15, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 4.0MM X 100MM X 150CM, OTW COYOTE BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING THE SECOND INFLATION AT 12 ATMOSPHERES FOR 10 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13538510 ↗