Coyote™ H74939186201010Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 08714729797135), received between Aug 27, 2018 and Nov 25, 2025 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (4 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 25, 2025Fluid/Blood Leak; Adverse Event Without Identified Device or Use Problem; Fluid/Blood Leak; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 31OCT2025. IT WAS REPORTED THAT BALLOON LEAK OCCURRED. THE 35% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED VESSEL. A 2.0MM X 100MM X 150CM COYOTE WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, UPON INSERTING AND INFLATING THE BALLOON, IT WAS NOTED THAT THE BALLOON WAS RAPIDLY LOSING PRESSURE AND CONTRAST LEAKAGE FROM THE INSUFFLATOR. AFTER REMOVAL, A SMALL LEAK NEAR THE PORT WAS FOUND, CAUSING THE LOSS OF PRESSURE. THE PROCEDURE WAS COMPLETED USING AN ALTERNATE DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED A BALLOON HOLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23649395 ↗
• MalfunctionOct 8, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. A 2.0MM X 100MM X 150CM COYOTE BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING INFLATION, THE BALLOON BURST WITHOUT REACHING THE RATED BURST PRESSURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23251129 ↗
• MalfunctionJun 20, 2023Material Rupture; Material Rupture

  IT WAS REPORTED, THAT BALLOON RUPTURE OCCURRED. THE 70% STENOSED TARGET WAS LOCATED IN THE MILDLY TORTUOUS, AND MODERATELY CALCIFIED VESSEL BELOW THE KNEE. A 2.0MM X 100MM X 150CM COYOTE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE INITIAL INFLATION AT NOMINAL PRESSURE IN LESS THAN A MINUTE, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED SUCCESSFULLY FROM THE PATIENT'S BODY. AND THE PROCEDURE WAS COMPLETED WITH DIFFERENT DEVICE, WITH NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17168039 ↗
• MalfunctionJan 12, 2023Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED THAT DEVICE CONTAMINATION OCCURRED. A 2.0MM X 100MM X 150CM COYOTE BALLOON CATHETER WAS OPENED DURING THE CASE. HOWEVER, AFTER OPENING THE OUTER BOX, IT WAS NOTED THAT THE INNER CLEAR PACKAGE WAS NOT SEALED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE, AND NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16146593 ↗
• MalfunctionMay 13, 2022Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT FROZE ON WIRE OCCURRED. THE PATIENT PRESENTED WITH PERIPHERAL ARTERY DISEASE (PAD). THE 80% STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND CALCIFIED TIBIAL VESSEL. FOLLOWING CROSSING OF A PLATINUM PLUS GUIDEWIRE IN THE LESION, A 2.0MM X 100MM X 150CM COYOTE BALLOON CATHETER WAS ADVANCED FOR DILATION AND WAS INFLATED AT 8 ATMOSPHERES FOR 2 MINUTES. THE BALLOON WAS THEN FULLY DEFLATED, HOWEVER, THE DEVICE BECAME STUCK ON THE WIRE. THE PHYSICIAN TRIED TO ADVANCE THE BALLOON AFTER DEFLATION TO LOOSEN IT FROM THE WIRE. EVENTUALLY, BOTH DEVICES WERE REMOVED INTACT AS A UNIT. THE PHYSICIAN THEN REWIRED WITH ANOTHER PLATINUM PLUS GUIDEWIRE, AND INTRAVASCULAR ULTRASOUND (IVUS) WAS PERFORMED. NO FURTHER TREATMENT WAS NEEDED AFTER IVUS AND THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14402375 ↗
• MalfunctionJun 13, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE TIBIAL ARTERY. A 2.0MM X 100MM X 150CM COYOTE AND A 2MM X 40MM X 144CM COYOTE ES BALLOON CATHETERS WERE USED CONSECUTIVELY FOR DILATATION. HOWEVER, DURING FIRST INFLATIONS, THE BALLOONS RUPTURED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8695194 ↗
• MalfunctionApr 22, 2019Inflation Problem; Inflation Problem

  REPORTABLE BASED ON ANALYSIS COMPLETED ON 05 APR 2019. IT WAS REPORTED THAT A BALLOON FAILED TO INFLATE. A PERCUTANEOUS CORONARY INTERVENTION WAS BEING PERFORMED ON A 60% STENOSED, SEVERELY CALCIFIED AND MILDLY TORTUOUS LESION. THE 2MM X 100MM X 150CM COYOTE BALLOON WAS POSITIONED AT THE LESION AND INFLATED BUT LOST PRESSURE AT 3-4 ATMOSPHERES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A DIFFERENT DEVICE WITHOUT ISSUE OR PATIENT INJURY. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED A PIN HOLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8536898 ↗
• MalfunctionAug 27, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA THE RIGHT FEMORAL ARTERY. THE 2MM X 80MM TARGET LESION WAS LOCATED IN THE NON TORTUOUS AND NON-CALCIFIED ANTERIOR TIBIAL ARTERY. A 2.0MM X 100MM X 150CM COYOTE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INFLATION, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED FROM THE PATIENT'S BODY. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7819078 ↗