Coyote™ H74939186200810Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 08714729796428), received between Oct 16, 2018 and Oct 9, 2025 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 9, 2025Entrapment of Device; Nonstandard Device; Material Integrity Problem; Entrapment of Device; Nonstandard Device; Material Integrity Problem

  IT WAS REPORTED THE BALLOON WAS STUCK ON WIRE. A 2.0MM X 80MM X 150CM, COYOTE WAS SELECTED FOR USE IN ANGIOPLASTY. DURING THE PROCEDURE, THE BALLOON CATHETER BECAME STUCK AND COULD NOT BE ADVANCED OR THE WIRE REMOVED INDEPENDENTLY. THE PHYSICIAN WAS REQUIRED TO WITHDRAW THE WIRE AND BALLOON CATHETER TOGETHER. UPON REMOVAL, THE BALLOON CATHETER APPEARED STRETCHED. THE DEVICE WAS REMOVED USING NORMAL METHOD WITHOUT ISSUE AND THE PROCEDURE WAS COMPLETED WITH ALTERNATE DEVICE USED. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23255815 ↗
• MalfunctionJul 8, 2025Entrapment of Device; Difficult to Advance; Entrapment of Device; Difficult to Advance

  IT WAS REPORTED THAT THE BALLOON CATHETER WAS ENTRAPPED ON A GUIDEWIRE. THE 70% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED VESSEL. A 2.0MM X 80MM X 150CM COYOTE BALLOON CATHETER WAS ADVANCED FOR DILATATION. DURING THE PROCEDURE, THE BALLOON WAS UNABLE TO TRACK OVER THE 0.018 NON-BSC GUIDEWIRE. ULTIMATELY, THE BALLOON CATHETER BECAME ENTRAPPED ON THE GUIDEWIRE. THE BALLOON CATHETER WAS REMOVED TOGETHER WITH GUIDEWIRE AND THE PROCEDURE WAS COMPLETED USING WITH ANOTHER BALLOON. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22436974 ↗
• MalfunctionNov 24, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURED. A 2.0MM X 80MM X 150CM COYOTE BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING INFLATION, THE BALLOON RUPTURED BEFORE REACHING THE RATED PRESSURE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20768079 ↗
• MalfunctionApr 1, 2024Break; Break

  IT WAS REPORTED THAT BALLOON FRACTURE OCCURRED. A 2.0MM X 80MM X 150CM COYOTE BALLOON CATHETER WAS SELECTED FOR USE. WHEN THE BALLOON WAS REMOVED FROM THE PROTECTIVE SPIRAL PACKAGING, A FRACTURE WAS FOUND IN THE BALLOON CATHETER. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19016010 ↗
• MalfunctionNov 28, 2022Material Rupture; Failure to Advance; Difficult to Advance; Material Rupture; Failure to Advance; Difficult to Advance

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE PATIENT PRESENTED WITH CHRONIC CRITICAL LIMB ISCHEMIA AND UNDERWENT VASCULAR INTERVENTION. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED AND SEVERELY TORTUOUS DISTAL TIBIAL VESSEL. A 2.0MM X 80MM X 150CM COYOTE BALLOON CATHETER AND A 1.5MM X 20MM X 142CM COYOTE ES BALLOON CATHETER WERE ADVANCED FOR DILATATION BUT HAD DIFFICULTY CROSSING THE LESION AND BOTH BALLOONS RUPTURED DURING THE INITIAL INFLATION. NO DEVICE FRAGMENTS WERE LEFT INSIDE THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER COYOTE BALLOON CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED. IT WAS FURTHER REPORTED THAT THE 1.5MM X 20MM X 142CM COYOTE ES BALLOON CATHETER CROSSED THE LESION; HOWEVER, IT BURST AS IT WAS BEING INFLATED AT ABOUT 8 ATMOSPHERES. THE 2.0MM X 80MM X 150CM COYOTE BALLOON CATHETER DID NOT CROSS THE LESION AND WAS NOT INFLATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15869264 ↗
• MalfunctionOct 28, 2021Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE 70% STENOSED TARGET LESION WAS LOCATED IN THE TIBIAL AND PERONEAL ARTERIES. A 2.0MM X 80MM X 150CM COYOTE BALLOON CATHETER WAS SELECTED FOR USE. HOWEVER, DURING THE PREPARATION, FRACTURE WAS OBSERVED IN THE SHAFT OF THE BALLOON WHEN ATTEMPTING TO INTRODUCE IT THROUGH THE GUIDE CATHETER. THE PROCEDURE WAS COMPLETED WITH ANOTHER COYOTE BALLOON CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12711666 ↗
• MalfunctionOct 16, 2018Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN A VESSEL IN A LOWER EXTREMITY. A 2.0MM X 80MM X 150CM COYOTE BALLOON CATHETER WAS SELECTED FOR USE. HOWEVER, THE DEVICE COULD NOT BE TRACKED OVER WIRE AS THE SHAFT WAS CRACKED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7970514 ↗