Coyote™ ES H74939134252010Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 08714729767367), received between Sep 26, 2018 and Jun 30, 2025 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (4 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 18, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 30, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. A 2.5 MM X 20 MM X 143 CM COYOTE ES BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, IT WAS NOTED THAT THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22356554 ↗
• MalfunctionApr 4, 2024Material 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 2.5MM X 20MM X 143CM COYOTE ES BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON RUPTURED UPON FIRST INFLATION AT 6 ATMOSPHERES FOR 5 SECONDS. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM, AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS IN GOOD CONDITION AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19045954 ↗
• MalfunctionApr 22, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND SEVERELY CALCIFIED RIGHT SUPERFICIAL FEMORAL ARTERY. A 2.5MM X 20MM X 143CM COYOTE ES BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE SECOND INFLATION AT ABOUT 10 ATMOSPHERES, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED WITHOUT ANY ISSUES. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9987075 ↗
• MalfunctionOct 24, 2018Inflation Problem; Inflation Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 02-OCT-2018. IT WAS REPORTED THAT BALLOON INFLATION FAILURE OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. AFTER A GUIDE WIRE WAS CROSSED, A 2.5MM X 20MM X 143CM COYOTE ES BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, THE DEVICE FAILED TO INFLATE. IT WAS PULLED OUT FROM THE SHEATH AS IT WAS. THE PHYSICIAN SAID THAT THE INFLATION LUMEN AND THE WIRE LUMEN WERE CONNECTED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED A PINHOLE IN THE GUIDE WIRE LUMEN. DEVICE EVALUATED BY MFR: RETURNED PRODUCT CONSISTED OF A COYOTE ES BALLOON CATHETER. THE OUTER SHAFT, INNER SHAFT, BALLOON AND TIP WERE VISUALLY AND MICROSCOPICALLY EXAMINED. VISUAL EXAMINATION DID NOT REVEAL ANY DAMAGES. MICROSCOPIC EXAMINATION REVEALED THAT THE TIP IS DAMAGED AND THERE IS A PINHOLE IN THE GUIDEWIRE LUMEN 2.6 CM FROM THE TIP. THERE IS BLOOD PRESENT IN THE GUIDEWIRE LUMEN AND THE BALLOON IS LOOSE. INSPECTION OF THE REMAINDER OF THE DEVICE PRESENTED NO OTHER DAMAGE OR IRREGULARITIES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7999495 ↗
• MalfunctionOct 19, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN A SHUNT IN THE MODERATELY TORTUOUS AND MILDLY CALCIFIED LEFT FOREARM. A 2.5MM X 20MM X 143CM COYOTE BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, ON INITIAL INFLATION AT 4 ATMOSPHERES FOR 5 SECONDS, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7987508 ↗
• MalfunctionSep 26, 2018Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED THAT A SEAL WAS MISSING. WHEN THE BOX FOR A 2.5MM X 20MM X 143CM COYOTE ES OTW BALLOON CATHETER WAS OPENED, IT WAS NOTED THAT THE INTERNAL PACKAGE HAD A SEAL MISSING FROM THE BOTTOM OF THE PACKAGE AND STERILITY COULD NOT BE GUARANTEED. THE PROCEDURE WAS COMPLETED WITH ANOTHER COYOTE BALLOON. THERE WAS NO SERIOUS INJURY OR ADVERSE PATIENT EFFECTS.

  Patient problems: No Patient Involvement

  MAUDE report 7911328 ↗