Coyote™ H74939186301010Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 08714729796565), received between Mar 11, 2019 and Apr 6, 2026 — classified as 1 injury, 10 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (6 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 6, 2026Inflation Problem; Material Rupture

  IT WAS REPORTED THAT BALLOON PINHOLE WAS NOTED. THE 40% STENOSED TARGET LESION WAS LOCATED IN A MODERATELY TORTUOUS AND MODERATELY CALCIFIED VESSEL. A 3.0MM X 100MM X 150CM COYOTE BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING INFLATION AT NOMINAL PRESSURE, THE BALLOON DID NOT INFLATE, AND A BALLOON PINHOLE WAS NOTED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24788740 ↗
• MalfunctionFeb 12, 2026Material Rupture

  IT WAS REPORTED THAT BALLOON BROKE OCCURRED. THE TARGET LESION WAS LOCATED IN THE BELOW-THE-KNEE (BTK), ANTERIOR TIBIAL ARTERY (ATA), TIBIALIS ANTERIOR. A 3.0MM X 100MM X 150CM COYOTE BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, DURING DEPLOYMENT AT THE NOMINAL PRESSURE OF 6 ATMOSPHERE (ATM) AND BEFORE REACHING 10 SECONDS, THE BALLOON WAS NOTED TO HAVE BROKEN AND WAS LEAKING. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24327773 ↗
• MalfunctionJan 26, 2026Material Puncture/Hole

  IT WAS REPORTED THAT SHAFT LEAK OCCURRED. A 3.0MM X 100MM X 150CM COYOTE BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING BALLOON PREPARATION, NEGATIVE PRESSURE WAS APPLIED TO EVACUATE AIR; HOWEVER, THE STEP COULD NOT BE COMPLETED DUE TO AN APPARENT AIR LEAK. A HOLE WAS NOTED IN THE MIDDLE OF THE CATHETER SHAFT. AFTER MULTIPLE ATTEMPTS TO RESOLVE THE ISSUE, THE BALLOON WAS REPLACED, AND THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE OF THE SAME TYPE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24179124 ↗
• MalfunctionJan 20, 2026Material Rupture

  IT WAS REPORTED THAT BALLOON WAS TORN. THE TARGET LESION WAS LOCATED IN THE POPLITEAL. A 3.0MM X 100MM X 150CM COYOTE BALLOON CATHETER WAS ADVANCED FOR DILATION. AFTER INFLATION IN THE VESSEL, THE BALLOON WAS REMOVED AND FOUND TO BE TORN. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THE TARGET LESION WAS 60% STENOSED, MODERATELY TORTUOUS AND BETWEEN MODERATE AND SEVERELY CALCIFIED. THE PATIENT'S ANATOMY WAS CHALLENGING DUE TO CALCIFICATION AND HAS CONTRIBUTED TO THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24121700 ↗
• MalfunctionDec 4, 2024Break; Difficult to Advance; Break; Difficult to Advance

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED VESSEL. A 3.0MM X 100MM X 150CM COYOTE BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING ADVANCING THROUGH THE GUIDEWIRE, THE BALLOON CATHETER BECAME STUCK. UPON REMOVAL, IT WAS NOTED THAT THE BALLOON'S MIDDLE SECTION BROKE IN TWO PIECES. THE PROCEDURE SUCCESSFULLY COMPLETED USING ORIGINAL METHOD AND/OR DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20847107 ↗
• MalfunctionMar 22, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE PATIENT WAS PRESENTED WITH PERIPHERAL ARTERIAL DISEASE. THE TOTALLY OCCLUDED TARGET LESION WAS LOCATED IN MINIMAL TORTUOUS AND SEVERELY CALCIFIED ARTERY. A 3.0MM X 100MM X 150CM, OTW COYOTE BALLOON CATHETER WAS ADVANCED FOR DILATATION. DURING FIRST INFLATION AT 8 ATMOSPHERES (ATM) FOR APPROXIMATELY ONE MINUTE, THE BALLOON WORKED WITHOUT ISSUE. AFTER THE SUCCESSFUL INFLATION, THE BALLOON WAS MOVED TO ANOTHER AREA OF THE VESSEL AND WAS INFLATED AGAIN. HOWEVER, DURING SECOND INFLATION AT ABOUT 8 ATM FOR ABOUT FEW SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED WITHOUT ANY FRAGMENTS LEFT FROM THE PATIENT, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16592524 ↗
• InjuryNov 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ELEGANCE CLINICAL STUDY. IT WAS REPORTED THAT VESSEL DISSECTION AND RECOIL OCCURRED. THE SUBJECT UNDERWENT TREATMENT WITH THE RANGER DRUG-COATED BALLOON ON (B)(6) 2021 AS A PART OF THE ELEGANCE CLINICAL TRIAL. THE TARGET LESION WAS IN THE RIGHT DISTAL POPLITEAL ARTERY, RIGHT ANTERIOR TIBIAL ARTERY (ATA), PERONEAL ARTERY, RIGHT TIBIAL TRUNK WITH 6.00 MM PROXIMAL REFERENCE VESSEL DIAMETER AND 6.00 MM DISTAL REFERENCE VESSEL DIAMETER WITH LESION LENGTH 40 MM WITH 80% STENOSIS AND WAS CLASSIFIED AS TASC II A LESION. PRIOR TO TARGET LESION TREATMENT, ATHERECTOMY WAS PERFORMED USING A 6F 140-SV NON-BOSTON SCIENTIFIC (BSC) ATHERECTOMY SYSTEM WITH CUTTER CATHETER DEVICE. THE TREATMENT OF TARGET LESION WAS PERFORMED BY DILATATION WITH 4 MM X 60 MM RANGER DRUG-COATED BALLOON. POST TREATMENT, THE FINAL RESIDUAL STENOSIS WAS NOTED TO BE 0%. ON THE SAME DAY, ANGIOGRAPHY REVEALED OCCLUSION IN THE RIGHT PROXIMAL ATA WHICH WAS TREATED BY BALLOON ANGIOPLASTY WITH 3 MM X 100 MM COYOTE BALLOON CATHETER THAT HAD LED TO DISSECTION AND RECOIL. AS A RESPONSE TO THE EVENT, BALLOON DILATIONS WERE PERFORMED USING 3 MM X 100 MM COYOTE OTW BALLOONS FOLLOWED BY PLACEMENT OF 3 MM X 38 MM AND 3.50 MM X 32 MM SYN

  Patient problems: Vascular Dissection

  MAUDE report 15839162 ↗
• MalfunctionNov 10, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE APPROXIMATELY 80% STENOSED, MEDIUM LENGTH TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND HIGHLY CALCIFIED ANTERIOR TIBIAL ARTERY. A 3.0MM X 100MM X 150CM COYOTE BALLOON CATHETER WAS FOR DILATATION. HOWEVER, DURING PROCEDURE, THE BALLOON WAS ADVANCED OVER THE WIRE INTO THE SHEATH AND IT WAS NOTICED THAT THE BALLOON APPEARED NOT WRAPPED, AS IF IT HAD BEEN INFLATED THEN DEFLATED. THE PHYSICIAN NOTICED BLOOD COMING OUT FROM THE INFLATION PORT, HE THEN REMOVED THE BALLOON FROM THE SHEATH. AN ENCORE 26 INFLATION DEVICE WAS ATTACHED TO THE INFLATION PORT OF THE BALLOON AND PULLED NEGATIVE, AND THE INFLATION DEVICE STARTED TO FILL WITH AIR. THE PROCEDURE WAS COMPLETED WITH ANOTHER COYOTE BALLOON. THERE WERE NO COMPLICATIONS AND THE PATIENT'S STATUS WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10817668 ↗
• MalfunctionMar 4, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESIONS WERE LOCATED IN THE ANTERIOR TIBIAL ARTERY (ATA) AND SUPERFICIAL FEMORAL ARTERY (SFA). A 3.0MM X 100MM X 150CM COYOTE BALLOON CATHETER WAS ADVANCED IN THE ATA AND A 6.0MMX40MMX135CM (4F) STERLING BALLOON CATHETER WAS PLACED IN SFA FOR DILATIONS. HOWEVER, DURING INFLATIONS, THE BALLOONS RUPTURED BEFORE REACHING THE NOMINAL PRESSURE. BOTH DEVICES WERE REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICES. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9787448 ↗
• MalfunctionDec 4, 2019Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT THE DEVICE BECAME ENTRAPPED ON THE GUIDEWIRE. THE TARGET LESION WAS LOCATED IN THE TIBIAL VESSEL AND THE PATIENT HAD CRITICAL LIMB ISCHEMIA. A 3.0MM X 100MM X 150CM COYOTE BALLOON CATHETER WAS ADVANCED FOR DILATION; HOWEVER, THE BALLOON WAS STUCK IN A NON-BSC GUIDE WIRE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9410988 ↗
• MalfunctionMar 11, 2019Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT THE BALLOON BECAME ENTRAPPED ON THE GUIDEWIRE. A 3.0MM X 100MM X 150CM COYOTE BALLOON CATHETER AND A SAVION FLX GUIDEWIRE WERE SELECTED FOR USE FOR A PERIPHERAL INTERVENTION PROCEDURE OF THE RIGHT ANTERIOR TIBIAL ARTERY. DURING THE PROCEDURE WHILE INSIDE THE PATIENT, THE COYOTE BALLOON BECAME STUCK ON THE SAVION FLX GUIDEWIRE. BOTH DEVICES WERE REMOVED FROM THE BODY TOGETHER AS A SYSTEM AND WERE THEN ABLE TO BE SEPARATED. IT WAS THEN OBSERVED THAT THERE WAS A KINK ON THE GUIDEWIRE AT THE POINT WHERE THE BALLOON WAS STUCK. THE PROCEDURE WAS COMPLETED USING A NEW COYOTE BALLOON CATHETER AND SAVION FLX GUIDEWIRE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS POST PROCEDURE WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8409903 ↗