Coyote™ H74939186201510Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 08714729796459), received between Jun 2, 2019 and Sep 25, 2024 — classified as 18 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (10 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED SUPERFICIAL FEMORAL ARTERY (SFA). A 2.0MM X 150MM X 150CM COYOTE BALLOON WAS ADVANCED FOR DILATION. HOWEVER, DURING THE FIRST INFLATION AT 8 ATMOSPHERES FOR 10 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS IN GOOD CONDITION POST-PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20305967 ↗
• MalfunctionSep 6, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE POSTERIOR TIBIAL ARTERY. A 2.0MM X 150MM X 150CM COYOTE BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, IT WAS NOTED THAT THE BALLOON WOULD NOT INFLATE WHEN IT WAS INJECTED WITH CONTRAST MEDIUM INTO THE PRESSURE PUMP. THE DEVICE WAS REMOVED, AND IT WAS CONFIRMED THAT THE BALLOON WAS LEAKING LIQUID AND HAD A TEAR. THE PROCEDURE WAS COMPLETED USING ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS REPORTED, AND PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20163794 ↗
• MalfunctionApr 9, 2024Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE 70% STENOSED TARGET LESION WAS LOCATED IN THE NOT VERY TORTUOUS AND MODERATE TO SEVERELY CALCIFIED PERIPHERAL ARTERY WITH NO IVUS. A 2.0MM X 150MM X 150CM COYOTE BALLOON CATHETER WAS SELECTED FOR TREATMENT AS THE PATIENT UNDERWENT AN ANGIOGRAM - LOWER LEG EXTREMITY. WHEN CROSSING INTO THE TIBIALIS, THE DEVICE WAS NOT FUNCTIONING PROPERLY, AND IT WAS NOTED THAT THE BALLOON WAS PARTIALLY FRACTURED WHILE STILL INTACT WITH THE CATHETER. THE DEVICE WAS REMOVED FROM THE PATIENT WHERE THE FRACTURE WAS LOCATED TO BE APPROXIMATELY ON THE PT. THE DEVICE WAS REPLACED FOR A DIFFERENT MODEL TO COMPLETE THE PROCEDURE. NO COMPLICATIONS REPORTED, AND PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19071108 ↗
• MalfunctionNov 6, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 2.0MM X 150MM X 150CM COYOTE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE FIRST INFLATION AT 8 ATMOSPHERES FOR 10 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED AND PATIENT CONDITION WAS GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18076534 ↗
• MalfunctionJul 5, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT A FOREIGN MATERIAL WAS PRESENT. A 2.0MM X 150MM X 150CM COYOTE BALLOON CATHETER WAS PREPARED FOR A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY. HOWEVER, DURING UNPACKING, A HAIR WAS NOTED IN THE STERILE PACKAGE. THE DEVICE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS IN GOOD CONDITION POST-PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17261664 ↗
• MalfunctionMar 27, 2023Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT THE BALLOON DEFLATION ISSUE OCCURRED. THE PATIENT PRESENTED WITH LOWER LIMB PERIPHERAL ARTERY DISEASE (PAD). THE 70% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND NONE CALCIFIED DORSALIS PEDIS ARTERY. A 2.0MM X 150MM X 150CM COYOTE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, THE BALLOON WOULD NOT DEFLATE PROPERLY. THE BALLOON WAS SLIGHTLY DEFLATED AND WAS ABLE TO BE REMOVED INTACT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16622411 ↗
• MalfunctionJul 26, 2022Difficult to Advance; Difficult to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 06-JUL-2022. IT WAS REPORTED THAT DIFFICULTY IN ADVANCING WAS ENCOUNTERED. A 2.0MM X 150MM X 150CM COYOTE BALLOON CATHETER WAS SELECTED FOR USE. HOWEVER, THERE WAS DIFFICULTY ADVANCING THE BALLOON CATHETER THROUGH THE GUIDE CATHETER. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO COMPLICATIONS REPORTED AND THE PATIENT STATUS WAS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED BALLOON DETACHMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15105426 ↗
• MalfunctionJul 20, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE SEVERELY STENOSED TARGET LESION WAS LOCATED IN THE RIGHT LOWER EXTREMITY ARTERY. A 2.0MM X 150MM X 150CM COYOTE BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING FIRST INFLATION AT 6 ATMOSPHERES FOR FEW SECONDS, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15071090 ↗
• MalfunctionDec 1, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED LEFT ANTERIOR TIBIAL ARTERY. A 2.0MM X 150MM X 150CM COYOTE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE FIRST INFLATION AT 8 ATMOSPHERES FOR 10 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT WAS IN GOOD CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12913697 ↗
• MalfunctionSep 22, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED RIGHT SUPERFICIAL FEMORAL ARTERY. A 2.0MM X 150MM X 150CM COYOTE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE INITIAL INFLATION AT 8 ATMOSPHERES, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12516293 ↗
• MalfunctionAug 26, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 60% STENOSED TARGET LESION CONTAINING 90 DEGREES BEND WAS LOCATED IN THE MILDLY TORTUOUS AND SEVERELY CALCIFIED POSTERIOR TIBIAL ARTERY. A 2.0MM X 150MM X 150CM COYOTE BALLOON CATHETER WAS ADVANCED FOR DILATATION AROUND THE BEND. THE BALLOON WAS INITIALLY INFLATED AT 14 ATMOSPHERES FOR 3 MINUTES. HOWEVER, DURING THE SECOND INFLATION AT 12 ATMOSPHERES, THE BALLOON RUPTURED AND THE DEVICE WAS REMOVED NORMALLY OVER A 300CM ANGLED TIP V-14 CONTROL WIRE. WHILE ATTEMPTING TO EXTRACT THE BALLOON AND THE WIRE FOR ANGIOGRAM, IT WAS FOUND THAT THE WIRE TIP WAS FRACTURED AND STUCK AT THE JUNCTION OF THE PLANTAR ARTERIES IN THE POSTERIOR TIBIAL ARTERY. APPROXIMATELY TWO HOURS WAS SPENT IN ATTEMPTING TO EXTRACT THE WIRE FRAGMENT USING A 3.2 FR NON-BOSTON SCIETIFIC SNARE. FINALLY, THE WIRE FRAGMENT WAS RETRACTED TO THE DISTAL SUPERFICIAL FEMORAL ARTERY LEVEL. HOWEVER, THE WIRE TIP EMBOLIZED INTO THE DORSALIS PEDIS AND ACCESS INTO THE DORSALIS PEDIS WAS GAINED. A NON- BOSTON SCIENTIFIC ASPIRATION CATHETER WAS USED AND WAS ABLE TO ASPIRATE THE WIRE FRAGMENT. THE LEFT LOWER EXTREMITY WAS IMAGED IN ITS ENTIRETY WITHOUT EVIDENCE OF RESIDUAL FRAGMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12375711 ↗
• MalfunctionJun 29, 2021Contamination; Unsealed Device Packaging; Contamination; Unsealed Device Packaging

  IT WAS REPORTED THAT UNSEALED DEVICE PACKAGING WAS ENCOUNTERED. A 2.0MM X 150MM X 150CM COYOTE BALLOON CATHETER WAS SELECTED FOR USE. HOWEVER, UPON OPENING THE BOX TO REMOVE THE BALLOON PACKAGING, THE BALLOON FELL OUT DUE TO UNSEALED PACKAGING. THE DEVICE WAS NOT USED INSIDE THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER BALLOON CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12085055 ↗
• MalfunctionOct 5, 2020Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT CATHETER ENTRAPMENT OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 2.0MM X 150MM X 150CM COYOTE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, THE NON-BSC GUIDEWIRE BECAME STUCK WITHIN THE DEVICE AND THE WHOLE SYSTEM WAS REMOVED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10632270 ↗
• MalfunctionJul 7, 2020Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 2.0MM X 150MM X 150CM COYOTE BALLOON CATHETER WAS SELECTED FOR USE. HOWEVER, DURING PREPARATION/PRIOR TO SEDATION, IT WAS NOTED THAT THERE WAS A FRACTURE ON THE CATHETER OF THE BALLOON SO IT WAS UNUSABLE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: No Patient Involvement

  MAUDE report 10240128 ↗
• MalfunctionApr 7, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED RIGHT SUPERFICIAL FEMORAL ARTERY. A 2.0MM X 150MM X 150CM COYOTE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, ON INITIAL INFLATION AROUND THE NOMINAL PRESSURE, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED WITHOUT PROBLEM AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9932475 ↗
• MalfunctionFeb 3, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED RIGHT ANTERIOR TIBIAL ARTERY. AFTER A 4.5F NON-BSC SHEATH WAS PLACED AND A NON-BSC GUIDEWIRE CROSSED THE LESION, A 2.0MM X 150MM X 150CM COYOTE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, UPON INITIAL INFLATION AT 4 ATMOSPHERES FOR 2 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH A 2-22 COYOTE BALLOON CATHETER. NO PATIENT COMPLICATIONS NOR INJURIES WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9660990 ↗
• MalfunctionAug 16, 2019Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT CATHETER ENTRAPMENT OCCURRED. THE 50% STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND MILDLY CALCIFIED RIGHT ANTERIOR TIBIAL ARTERY. A 2.0MM X 150MM X 150CM COYOTE BALLOON CATHETER WAS ADVANCED ONTO THE .014, 300CM THRUWAY GUIDEWIRE FOR DILATATION. HOWEVER, THE BALLOON AND THE GUIDEWIRE WERE STUCK TOGETHER. THE TWO DEVICES WERE COMPLETELY REMOVED FROM THE PATIENT'S BODY AND THE PROCEDURE WAS COMPLETED WITH A NEW WIRE AND ANOTHER OF THE SAME BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED. IT WAS FURTHER REPORTED THAT WHEN THE PHYSICIAN REALIZED THERE WAS AN ISSUE ADVANCING THE BALLOON, THEY TRIED PULLING THE BALLOON BACK OVER THE WIRE AND ALSO SIMPLY PULLING THE WIRE. WHEN THESE ATTEMPTS FAILED, THE SYSTEM WAS PULLED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8902359 ↗
• MalfunctionJun 2, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED ANTERIOR TIBIAL ARTERY. A 2.0MM X 150MM X 150CM COYOTE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE FIRST INFLATION AT 14 ATMOSPHERES FOR 15 SECONDS, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8661306 ↗