Coyote™ H74939186251210Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08714729796527), received between Jul 12, 2019 and Aug 12, 2025 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Entrapment of Device” (2 reports).

1 FDA recall record name this device's identifier, 1 still open.

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 18, 2026.

Recalls naming this device

1. Dec 3, 2025Class IIOpen, Classified

   Boston Scientific is initiating the removal of certain batches of Coyote" Over-the-Wire (OTW) Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter devices due to the potential for inflation/deflation difficulty during use in the peripheral vasculature. An internal investigation found that a manufacturing process variation resulted in catheters that may not properly inflate/deflate. This was limited to Coyote OTW batches manufactured from 12Sep2025 through 13Oct2025. The processing variation has since been addressed. No other material numbers or batches are impacted by this removal.

   Z-1042-2026 · Root cause: Process change control · Recall details · FDA record ↗

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.

• MalfunctionAug 12, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 70% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED VESSEL BELOW THE KNEE. A 2.5MM X 120MM X 150CM COYOTE OTW BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING FIRST INFLATION AT NOMINAL ATMOSPHERES, THE BALLOON BURST. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22783269 ↗
• MalfunctionJun 30, 2021Leak/Splash; Leak/Splash

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 16-JUN-2021. IT WAS REPORTED THAT BALLOON LEAK OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN MILDLY TORTUOUS SUPERFICIAL FEMORAL ARTERY. A 2.5MM X 120MM X 150CM COYOTE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INFLATION AT 4-5 ATMOSPHERES, THE BALLOON BURST AND CONTRAST LEAK WAS NOTICED. THE DEVICE WAS REMOVED IN NORMAL FASHION AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED BALLOON PINHOLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12096866 ↗
• MalfunctionMar 11, 2021Entrapment of Device; Material Integrity Problem; Entrapment of Device; Material Integrity Problem

  IT WAS REPORTED THAT CATHETER ENTRAPMENT OCCURRED. THE 85 PERCENT STENOSED TARGET LESION WAS LOCATED IN A MILDLY CALCIFIED AND MILDLY TORTUOUS LESION BELOW THE KNEE. A 2.5MM X 120MM X 150CM, OTW COYOTE BALLOON CATHETER WAS ADVANCED OVER THE GUIDEWIRE. HOWEVER, AFTER CROSSING ABOUT 20CM ON THE GUIDEWIRE, THE CATHETER WAS STUCK AND THE PHYSICIAN WAS UNABLE TO ADVANCE OR RETRIEVE THE CATHETER. IT WAS OBSERVED THAT THE CATHETER TIP WAS KINKED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED AND THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11464596 ↗
• MalfunctionJul 12, 2019Entrapment of Device; Difficult to Advance; Material Deformation; Entrapment of Device; Difficult to Advance; Material Deformation

  IT WAS REPORTED THAT A BALLOON DEVICE KINKED AND FROZE ON THE GUIDE WIRE. THE TARGET LESION WAS LOCATED IN MODERATELY CALCIFIED AND MILDLY TORTIOUS RIGHT TIBIALIS ANTERIOR. THE TIBIALIS ANTERIOR WAS RECANALIZED WITH A 300 CM V 14 CONTROL WIRE (GUIDEWIRE). A 2.5MM X 120MM X 150CM COYOTE BALLOON WAS PLACED OVER THE GUIDEWIRE. BECAUSE OF STRONG FORCES FORM THE HARD CALCIFIED VESSEL, THE COYOTE KINKED WITH THE GUIDEWIRE AND NO MOVEMENT WAS POSSIBLE. FORWARD AND BACKWARD MOVEMENTS WITH THE WIRE IN THE CATHETER WERE NOT POSSIBLE. THE DEVICES WERE REMOVED FROM THE PATIENT AND IT WAS NOTICED THAT A 3MM TIP FROM THE WIRE WAS MISSING. IT WAS FIXED BY ADVANCING ANOTHER CATHETER IN THE VESSEL WALL. INTERVENTION WAS SUCCESSFULLY FINISHED AND THE PATIENT STATUS WAS WELL. IT WAS NOTED THAT THE CAUSE OF THE EVENT WAS RELATED TO THE KINK OF THE COYOTE BALLOON CATHETER. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8784489 ↗