Coyote™ H74939186300610Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729797227), received between Dec 18, 2020 and Nov 8, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Entrapment of Device” (2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 8, 2021Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT CATHETER ENTRAPMENT ON GUIDEWIRE OCCURRED. THE TARGET LESION WAS LOCATED IN A VESSEL OF THE LOWER LEG. A 014/300/SST PLATINUM PLUS - PI GUIDEWIRE WAS ADVANCED. A 3.0MM X 60MM X 150CM, OTW COYOTE BALLOON CATHETER WAS ADVANCED FOR DILATION. AT SOME POINT DURING THE PROCEDURE, THE TIP OF THE 014/300/SST PLATINUM PLUS - PI GUIDEWIRE UNRAVELED. WHILE ATTEMPTING TO REMOVE THE 3.0MM X 60MM X 150CM, OTW COYOTE BALLOON CATHETER AT THE END OF THE PROCEDURE, THE COYOTE BALLOON CATHETER AND PLATINUM PLUS PI GUIDEWIRE COULD NOT BE SEPARATED AND WERE REMOVED TOGETHER FROM THE PATIENT. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12771731 ↗
• MalfunctionDec 18, 2020Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT CATHETER ENTRAPMENT OCCURRED. A 3.0MM X 60MM X 150CM COYOTE BALLOON CATHETER WAS SELECTED FOR USE; HOWEVER, THE BALLOON CATHETER BECAME STUCK ON THE GUIDEWIRE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 11036776 ↗