Coyote™ H74939186352210Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08714729797326), received between Aug 23, 2019 and Oct 31, 2025 — classified as 4 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.

• MalfunctionOct 31, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 95% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED VESSEL. A 3.5MM X 220MM X 150CM COYOTE BALLOON CATHETER WAS SELECTED FOR LEFT LEG ANGIOGRAM. DURING THE PROCEDURE, THE BALLOON RUPTURED UPON SECOND INFLATION AT 14 ATMOSPHERES FOR 3 SECONDS. THERE WERE NO DEVICE FRAGMENTS LEFT INSIDE THE PATIENT. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM, AND THE PROCEDURE WAS COMPLETED WITH ORIGINAL METHOD/DEVICE USED. THERE WERE NO PATIENT COMPLICATIONS AS RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23438851 ↗
• MalfunctionAug 27, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE PATIENT WAS BEING TREATED FOR PERIPHERAL ARTERY DISEASE. THE 70% STENOSED TARGET LESION WAS LOCATED IN A MILDLY TORTUOUS AND MODERATELY CALCIFIED ARTERY. A 3.5MM X 220MM X 150CM COYOTE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE FIRST INFLATION AT 8 ATMOSPHERES, THE BALLOON RUPTURED AND WOULD NOT HOLD PRESSURE. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER COYOTE BALLOON CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17628874 ↗
• MalfunctionAug 22, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR TIBIAL ARTERY. A 3.5MM X 220MM X 150CM COYOTE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE FIRST INFLATION AT 7 ATMOSPHERES, THE BALLOON RUPTURED. AFTER A 1.75MM ROTABLATION WAS PERFORMED AND THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15272454 ↗
• MalfunctionAug 23, 2019Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component

  IT WAS REPORTED THAT A COYOTE BALLOON WAS STUCK ON THE WIRE. A CONTRALATERAL ACCESS WAS GAINED VIA PERONEAL ARTERY. A 3.5MM X 220MM X 150CM COYOTE BALLOON AND 150 CM RUBICON 14 WERE SELECTED FOR USE. DURING PROCEDURE, RESISTANCE WAS NOTED WHEN RUBICON DEVICE WAS ADVANCED OVER A NON BSC 0.14 WIRE. WHEN THE DEVICES WAS ADVANCED FURTHER THE CATHETER BUCKLED AND THE WIRE GOT KINKED. THE CATHETER AND THE WIRE WERE REMOVED AND REPLACED A LARGER CATHETER SIZE AND A NEW NON BSC WIRE. SUBSEQUENTLY, THE COYOTE BALLOON WAS ADVANCED OVER A NON BSC WIRE TO THE PERONEAL SITE. THE BALLOON WAS INFLATED INTO A NOMINAL PRESSURE, HOWEVER THE BALLOON COULD NOT REMOVED WHEN TRYING TO PULL OUT. IT GO STUCK ON THE WIRE. THE PHYSICIAN ATTEMPTED TO REMOVE THE DEVICE BY ADDING ONE BAR OF PRESSURE. FINALLY WITH FORCE THEY WERE ABLE TO REMOVE THE DEVICE FROM THE PATIENT'S BODY. HOWEVER, THE BALLOON WAS SEPARATED FROM THE CATHETER. THE DEVICES USED WERE REMOVED AS A UNIT. POSITIONING WAS LOST SO THE PROCEDURE WAS COMPLETED WITH A NEW NON BSC WIRE TO ADVANCE INTO THE LESION AND ANOTHER OF THE SAME BALLOON TO DILATE THE AREA. THE PROCEDURE WAS COMPLETED WITHOUT ANY FURTHER COMPLICATIONS TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8925179 ↗