Coyote™ H74939185201010Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 08714729796787), received between Apr 6, 2020 and Jul 23, 2024 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (6 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.

• MalfunctionJul 23, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 2.0MM X 100MM X 150CM COYOTE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INFLATION, THE BALLOON RUPTURED BEFORE REACHING THE BURST RATE PRESSURE. THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED. IT WAS FURTHER REPORTED THAT THE 80-90% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED ANTERIOR TIBIAL ARTERY. THE BALLOON WAS RUPTURED DURING FIRST INFLATION AT 10ATMOSPHERES FOR 2 MINUTES. THE DEVICE WAS REMOVED VIA FEMORAL SHEATH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19804245 ↗
• MalfunctionJan 29, 2024Entrapment of Device; Difficult to Advance; Material Integrity Problem; Entrapment of Device; Difficult to Advance; Material Integrity Problem

  IT WAS REPORTED THAT THE BALLOON WAS ENTRAPPED ON THE WIRE. THE 70% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED ANTERIOR TIBIAL ARTERY. A 2.0MM X 100MM X 150CM COYOTE BALLOON CATHETER AND A 0.014 FATHOM GUIDEWIRE WERE SELECTED USE IN A BELOW-THE-KNEE PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE (PTA). DURING THE PROCEDURE, THE COYOTE BALLOON CATHETER WAS ADVANCED OVER THE FATHOM GUIDEWIRE. HOWEVER, RESISTANCE WAS FELT JUST BELOW THE KNEE JOINT AND THE COYOTE BALLOON CATHETER COULD NOT ADVANCE FURTHER. REMOVAL WAS ATTEMPTED BUT THE BALLOON BECAME ENTRAPPED ON THE FATHOM GUIDEWIRE. THE BALLOON CATHETER AND GUIDEWIRE WERE REMOVED TOGETHER. THE PHYSICIAN OBSERVED THAT THE TIP OF THE BALLOON WAS DAMAGED. THE PROCEDURE WAS COMPLETED WITH ANOTHER PTA BALLOON AND GUIDEWIRE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS OKAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18595525 ↗
• MalfunctionMar 15, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED BELOW THE KNEE VESSEL. A 2.0MM X 100MM X 150CM COYOTE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INITIAL INFLATION AT 14 ATMOSPHERES FOR 5 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS NOR INJURIES WERE REPORTED AND THE PATIENT WAS IN GOOD CONDITION AFTER THE PROCEDURE.

  MAUDE report 13766416 ↗
• MalfunctionOct 28, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 95% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND MODERATELY CALCIFIED ANTERIOR TIBIAL ARTERY. A 2.0MM X 100MM X 150CM, MR COYOTE BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING FIRST INFLATION AT 10 ATMOSPHERES FOR 20 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT WAS IN GOOD CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12710437 ↗
• MalfunctionNov 12, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY CALCIFIED VESSEL BELOW THE KNEE. A 2.0MM X 100MM X 150CM COYOTE BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, ON THE SECOND INFLATION AT 14 ATMOSPHERES, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED WITHOUT PROBLEM AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10831665 ↗
• MalfunctionJul 16, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED LEFT POSTERIOR TIBIAL ARTERY. A 2.0MM X 100MM X 150CM COYOTE BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING INFLATION AT 6 ATMOSPHERES, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10286928 ↗
• MalfunctionApr 6, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED RIGHT ANTERIOR TIBIAL ARTERY. A 2.0MMX100MMX150CM COYOTE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE FIRST INFLATION AT NOMINAL PRESSURE, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9928938 ↗