Coyote™ H74939186250810Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 08714729797180), received between Mar 25, 2019 and Jun 4, 2025 — classified as 2 injuries, 8 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 4, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 2.5MM X 80MM X 150CM COYOTE BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, IT WAS NOTED THAT THE BALLOON BURST EVEN WITHOUT REACHING THE BURST RATED PRESSURE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22142129 ↗
• MalfunctionOct 22, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE STENOSED TARGET LESION WAS LOCATED IN THE TIBIAL ARTERY. A 2.5MM X 80MM X 150CM COYOTE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INFLATION AT 14 ATMOSPHERES, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20509199 ↗
• InjuryJun 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ELEGANCE CLINICAL STUDY IT WAS REPORTED THAT VESSEL DISSECTION OCCURRED. IN (B)(6) 2023, THE SUBJECT UNDERWENT TREATMENT WITH RANGER DRUG COATED BALLOON AND ELUVIA DRUG-ELUTING STENT AS A PART OF THE ELEGANCE CLINICAL TRIAL. THE TARGET LESION #001 WAS IN THE RIGHT MID POPLITEAL ARTERY EXTENDING INTO RIGHT DISTAL POPLITEAL ARTERY WITH PROXIMAL REFERENCE VESSEL DIAMETER OF 4 MM AND DISTAL REFERENCE VESSEL DIAMETER OF 4 MM WITH LESION LENGTH OF 60 MM AND 75% STENOSIS AND WAS CLASSIFIED AS TASC II D LESION. TREATMENT OF TARGET LESION WAS PERFORMED BY DILATION USING STUDY DEVICE, 4 MM X 60 MM OF RANGER DRUG-COATED BALLOON. POST TREATMENT, THE FINAL RESIDUAL STENOSIS WAS NOTED TO BE 30%. THE TARGET LESION #002 WAS IN THE RIGHT DISTAL SUPERFICIAL FEMORAL ARTERY WITH PROXIMAL REFERENCE VESSEL DIAMETER OF 6 MM AND DISTAL REFERENCE VESSEL DIAMETER OF 6 MM WITH LESION LENGTH OF 15 MM AND 80% STENOSIS AND WAS CLASSIFIED AS TASC II D LESION. TREATMENT OF TARGET LESION WAS PERFORMED BY PLACEMENT OF STUDY DEVICE, 6 MM X 40 MM ELUVIA DRUG-ELUTING STENT. FOLLOWING POST-DILATION WAS PERFORMED WITH 6 MM X 40 MM MUSTANG PTA BALLOON AND 4 MM X 40 MM ADVANCE PTA BALLOON AND THE FINAL RESIDUAL STENOSIS W

  Patient problems: Vascular Dissection

  MAUDE report 17038799 ↗
• MalfunctionJul 25, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 70% STENOSED TARGET LESION WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY. A 2.5MM X 120MM X 150CM STERLING SL AND A 2.5MM X 80MM X 150CM COYOTE BALLOON CATHETERS WERE ADVANCED FOR DILATION. BOTH BALLOON REACHED THE LESION SITE. HOWEVER, DURING INFLATION AT 12 ATMOSPHERES, BOTH BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED. THE PATIENT WAS IN STABLE CONDITION FOLLOWING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15098935 ↗
• MalfunctionNov 29, 2021Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT CATHETER ENTRAPMENT OCCURRED. THE TARGET LESION WAS LOCATED IN A VESSEL BELOW THE KNEE. A 300CM STRAIGHT TIP V-14 CONTROL WIRE WAS ADVANCED TO CROSS THE LESION. HOWEVER, IT WAS NOTED THAT THE WIRE TIP WAS TORN APART FROM THE WIRE BODY AND NEED TO USE A SNARE TO REMOVE IT OUT. IT WAS ALSO FOUND THAT THE WIRE BECAME STUCK IN THE 2.5MM X 80MM X 150CM COYOTE BALLOON CATHETER. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT CONDITION WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12887104 ↗
• MalfunctionAug 18, 2021Difficult to Advance; Adverse Event Without Identified Device or Use Problem; Difficult to Advance; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 27JUL2021. IT WAS REPORTED THAT THE CATHETER COULD NOT MOVE OVER THE GUIDEWIRE. A 2.5X80X150 COYOTE BALLOON WAS SELECTED FOR A PROCEDURE. DURING THE PROCEDURE, IT WAS REPORTED THAT THE COYOTE WAS NOT ABLE TO MOVE OVER THE .014 V-14 GUIDEWIRE. THERE WERE NO PATIENT COMPLICATIONS REPORTED. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING AN ALTERNATE DEVICE. HOWEVER, DEVICE ANALYSIS REVEALED THAT AN UNKNOWN .014 WIRE WAS STUCK IN THE CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12336029 ↗
• InjuryDec 30, 2019Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT A DEVICE COMPONENT WAS LEFT INSIDE THE PATIENT. THE BALLOON PROTECTOR WAS NOT REMOVED PRIOR TO INTRODUCING A 2.5MM X 80MM X 150CM COYOTE BALLOON CATHETER INTO THE PATIENT. THE BALLOON PROTECTOR SLEEVE CAME OFF AND WENT DOWN THE PATIENT'S ARTERY AND WAS NOT ABLE TO BE REMOVED. THE PROCEDURE WAS IMMEDIATELY STOPPED. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS DOING OKAY. IT WAS FURTHER REPORTED THAT PATIENT COMPLICATIONS OCCURRED. PROTECTIVE OUTER SHEATH FROM 2.5X80X150 COYOTE BALLOON WAS RETAINED IN PATIENTS BODY, AND THE PROCEDURE PERFORMED WAS: EXPLORATION DISTAL LEFT ANTERIOR TIBIALIS ARTERY WITH REMOVAL OF FOREIGN BODY AND VEIN PATCH ANGIOPLASTY. PREOPERATIVE DIAGNOSIS WAS NON- HEALING ULCER ON LEFT FOOT, AND THE PROCEDURE PERFORMED WAS: PERCUTANEOUS ULTRASOUND GUIDED DYNAMIC AORTOGRAM WITH BILATERAL LOWER EXTREMITY RUNOFF WITH INTERPRETATION LEFT POPLITEAL AND ANTERIOR TIBIALIS ARTERY DIRECTIONAL ATHERECTOMY WITH LEFT POPLITEAL ARTERY DRUG COATED BALLOON ANGIOPLASTY AND LEFT AT ANGIOPLASTY. PATIENT WAS DISCHARGED HOME ON 12DEC2019. NO PROGNOSIS NOTES FOUND YET.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9532593 ↗
• MalfunctionNov 4, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT A BALLOON RUPTURE HAD OCCURRED. A TIBIALPLASTY PROCEDURE WAS BEING PERFORMED. THE 2.5MM X 80MM X 150CM COYOTE BALLOON RUPTURED ON THE FIRST INFLATION AT NOMINAL PRESSURE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A DIFFERENT DEVICE WITHOUT ISSUE OR PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9274201 ↗
• MalfunctionApr 15, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA BRACHIAL ARTERY. THE 60% STENOSED, 50 X 9.62MM, CONCENTRIC, DE NOVO TARGET LESION WAS LOCATED IN A MILDLY TORTUOUS AND NON-CALCIFIED BRACHIOCEPHALIC VEIN. A 2.5MM X 80MM X 150MM COYOTE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, UPON INITIAL INFLATION AT 12 ATMOSPHERES, THE BALLOON RUPTURED. THE DEVICE WAS COMPLETELY REMOVED AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8515609 ↗
• MalfunctionMar 25, 2019Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT CATHETER ENTRAPMENT OCCURRED. AFTER A 300 CM VICTORY GUIDE WIRE CROSSED THE LESION, A 2.5MM X 80MM X 150CM COYOTE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, THE WIRE BECAME STUCK WITH THE BALLOON SHAFT AND IT WOULD NOT MOVE, WHEN BOTH DEVICES WERE COMPATIBLE. ACCORDING TO THE TECHNICIAN, THE GUIDE WIRE AND THE BALLOON CATHETER MAY HAVE NOT PROPERLY FLUSHED. THE PROCEDURE WAS COMPLETED WITH ANOTHER WIRE AND BALLOON CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8449189 ↗