Coyote™ H74939186251010Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08714729796503), received between Mar 25, 2019 and Oct 16, 2025 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Difficult to Advance” (1 report).

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 16, 2025Difficult to Remove; Difficult to Advance; Difficult to Remove; Difficult to Advance

  IT WAS REPORTED THAT BALLOON WAS DIFFICULT TO REMOVE. THE TARGET LESION WAS LOCATED IN THE RIGHT POPLITEAL/TIBIAL/PERONEAL TRUNK VESSEL. A 2.5MM X 100MM X 150CM WAS SELECTED FOR USE IN A LOWER EXTREMITY PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY. THE BALLOON EXHIBITED DIFFICULTY TRACKING OVER THE WIRE BOTH DURING ADVANCEMENT AND WITHDRAWAL. THE BALLOON WAS REMOVED, AND THE WIRE WAS FLUSHED AND WIPED, HOWEVER, TRACKING DIFFICULTY PERSISTED. THE PHYSICIAN SWITCHED TO A NON-BSC WIRE, BUT SIMILAR RESISTANCE WAS ENCOUNTERED DURING ADVANCEMENT AND REMOVAL OF THE BALLOON. THE DEVICE WAS REMOVED USING NORMAL METHOD WITHOUT ISSUE AND THE PROCEDURE WAS COMPLETED WITH ALTERNATE DEVICE. THERE WAS NO PATIENT COMPLICATION AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23312499 ↗
• MalfunctionApr 28, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 60% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED ANTERIOR TIBIAL ARTERY. A 2.5MM X 100MM X 150CM COYOTE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING FIRST INFLATION, IT WAS NOTED THAT THE PRESSURE DROPPED BEFORE 6 ATMOSPHERES AND BLOOD CAME BACK THROUGH THE INFLATION DEVICE. THE DEVICE WAS COMPLETELY REMOVED AND THE PROCEDURE WAS COMPLETED WITH A 2.5MMX150MMX150CM COYOTE BALLOON CATHETER. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT CONDITION WAS GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16834767 ↗
• MalfunctionJan 25, 2023Failure to Deflate; Failure to Deflate

  IT WAS REPORTED THAT DEFLATION ISSUE OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA FEMORAL ARTERY. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED ANTERIOR TIBIAL ARTERY. A 2.5MM X 100MM X 150CM, OTW COYOTE BALLOON CATHETER WAS ADVANCED FOR DILATATION. THE BALLOON WAS INFLATED AT 8 ATMOSPHERES FOR 2 MINUTES WITH A SALINE CONTRAST RATIO OF 3:1. HOWEVER, DURING THE PROCEDURE, THE BALLOON SHOWS PERSISTENTLY INFLATED EVEN AFTER DEFLATING IT. DEFLATION ACTIVITY WAS DONE WITH HELP OF A NON-BOSTON SCIENTIFIC INFLATION DEVICE BY PULLING THE PLUNGER BACK RELEASE THE LOCKING LEVER. SUBSEQUENTLY, THE BALLOON WAS REMOVED THROUGH THE SHEATH CAREFULLY FOR 3 MINUTES. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO COMPLICATIONS REPORTED AND THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16243805 ↗
• MalfunctionMar 25, 2019Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT A FROZE ON WIRE OCCURRED. THE 70% STENOSED TARGET LESION WAS LOCATED IN THE ANTERIOR TIBIAL ARTERY. A 2.5MM X 100MM X 150CM COYOTE BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, THE BALLOON AND A NON BSC GUIDEWIRE WAS STUCK FIRMLY INSIDE THE PATIENT'S BODY AND CANNOT BE WITHDRAWN. BOTH DEVICES WERE REMOVED TOGETHER. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8449908 ↗