Coyote™ H74939186251510Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 08714729796534), received between Mar 28, 2019 and Oct 15, 2025 — classified as 15 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (11 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 15, 2025Fluid/Blood Leak; Leak/Splash; Material Rupture; Fluid/Blood Leak; Leak/Splash; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 50-60% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED VESSEL BELOW THE KNEE. A 2.5MM X 150MM X 150CM COYOTE BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON RUPTURED AND LEAKED ON INITIAL INFLATION AT 6 ATMOSPHERES. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS RESULT OF THE EVENT. IT WAS FURTHER REPORTED THAT THE BALLOON RUPTURED DURING INFLATION AT 3 ATMOSPHERES. THE BALLOON WAS REMOVED BY SIMPLY PULLING OUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23280912 ↗
• MalfunctionMar 14, 2025Failure to Deflate; Failure to Deflate

  IT WAS REPORTED THAT BALLOON DEFLATION ISSUE OCCURRED. A 2.5MM X 150MM X 150CM COYOTE BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, IT WAS NOTED THAT THE BALLOON WAS NOT DEFLATING. THE PROCEDURE WAS COMPLETED VIA ALTERNATIVE METHOD. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21607849 ↗
• MalfunctionAug 12, 2024Inflation Problem; Material Rupture; Inflation Problem; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LOCATION WAS LOCATED IN THE MODERATE CALCIFIED VEIN. A 2.5MM X 150MM X 150CM COYOTE BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON DID NOT INFLATE AND WHEN EXPLANTED, A TEAR WAS NOTED. ANOTHER 2.0MM X 120MM X 150CM COYOTE BALLOON WAS USED AND IT BURST UPON SECOND INFLATION AT 6 ATMOSPHERES. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM, AND THE PROCEDURE WAS COMPLETED WITH ALTERNATIVE METHOD. NO PATIENT COMPLICATIONS WERE REPORTED. IT WAS FURTHER REVIEW REPORTED THE DEVICE WAS SIMPLY PULLED OUT AND THAT NO FRAGMENTS INSIDE THE PATIENT'S BODY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19960202 ↗
• MalfunctionMay 5, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. VASCULAR ACCESS WAS OBTAINED THE VIA THE RIGHT FEMORAL ARTERY. THE 95% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED RIGHT ANTERIOR TIBIAL ARTERY. AFTER INSERTING A NON-BOSTON SCIENTIFIC (BSC) INTRODUCER SHEATH, A NON-BSC GUIDEWIRE WAS USED TO CROSS THE LESION. A 2.5MM X 150MM X 150CM, OTW COYOTE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE FIRST INFLATION AT 10 ATMOSPHERES FOR 10 SECONDS, THE BALLOON RUPTURED AND A PINHOLE WAS NOTED IN THE MIDDLE PART. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS IN GOOD CONDITION POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14287126 ↗
• MalfunctionFeb 18, 2022Entrapment of Device; Difficult to Advance; Device Dislodged or Dislocated; Entrapment of Device; Difficult to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT FROZE ON WIRE OCCURRED. A V-14 CONTROL WIRE WAS ADVANCED AND PLACED IN THE PATIENT. DURING LOADING OF A 2.5MM X 150MM X 150CM COYOTE OTW BALLOON CATHETER ONTO THE GUIDEWIRE, THE DEVICE BECAME STUCK ON THE GUIDEWIRE AND WAS NOT ABLE TO BE ADVANCED OR REVERSED OFF OF THE GUIDEWIRE. THE BALLOON HAD NOT ENTERED THE SHEATH OR PATIENT AT THIS POINT. THE GUIDEWIRE HAD TO BE REMOVED FROM THE PATIENT AND WIRE ACCESS WAS LOST. WHEN THE PHYSICIAN INSPECTED THE BALLOON, IT APPEARED THAT THE DISTAL MARKER OF THE BALLOON HAD BECOME REMOVED FROM THE SHAFT OF THE BALLOON. THE PROCEDURE WAS COMPLETED WITH ANOTHER GUIDEWIRE AND ANOTHER OF THE SAME BALLOON. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13559512 ↗
• MalfunctionFeb 15, 2022Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT THE BALLOON BECAME STUCK WITH THE ROTAWIRE. THE 85% STENOSED TARGET LESION WAS LOCATED IN THE NON TORTUOUS AND NON CALCIFIED PERINEAL ARTERY. A 2.5MMX150MMX150CM COYOTE AND A 330CM ROTAWIRE AND WIRECLIP TORQUER WERE SELECTED FOR USE. DURING THE PROCEDURE, THE BALLOON WAS INFLATED AT NOMINAL PRESSURE AND IT WAS NOTED THAT THE BALLOON BECAME STUCK WITH THE ROTAWIRE. BOTH BALLOON AND ROTAWIRE WERE REMOVED TOGETHER AS ONE UNIT WITH NO ISSUES AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13534761 ↗
• MalfunctionMay 19, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED ANTERIOR TIBIAL ARTERY. A 2.5MM X 150MM X 150CM COYOTE BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING FIRST INFLATION AT 8 ATMOSPHERES FOR 10 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED WITHOUT PROBLEM. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED AND THE PATIENT WAS IN GOOD CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11846533 ↗
• MalfunctionMar 2, 2021Material 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 2.5MM X 150MM X 150CM COYOTE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INITIAL INFLATION, THE BALLOON RUPTURED. THE DEVICE WAS COMPLETELY REMOVED AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED AND THE PATIENT WAS IN GOOD CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11397902 ↗
• MalfunctionJul 6, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. VASCULAR ACCESS WAS OBTAINED BY IPSILATERAL APPROACH VIA THE FEMORAL ARTERY. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY CALCIFIED LEFT SUPERFICIAL FEMORAL ARTERY - BELOW THE KNEE. AFTER CROSSING THE GUIDEWIRE, A 2.5MM X 150MM X 150CM COYOTE BALLOON CATHETER WAS ADVANCED FOR DILATION. THE BALLOON WAS INITIALLY INFLATED AT NOMINAL PRESSURE; HOWEVER, ON THE SECOND INFLATION AT ABOUT 10 ATMOSPHERES, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER SAME SIZE COYOTE BALLOON CATHETER. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10237853 ↗
• MalfunctionDec 2, 2019Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT GUIDEWIRE ENTRAPMENT OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY CALCIFIED LEFT POSTERIOR TIBIAL ARTERY (PT). A 2.5MM X 150MM X 150CM COYOTE BALLOON CATHETER AND A 014/300/SST PLATINUM PLUS GUIDEWIRE WERE ADVANCED FOR USE. HOWEVER, DURING PROCEDURE, THE BALLOON COULD NOT BE ADVANCED TO THE DISTAL PT. WHEN THE BALLOON WAS PULLED BACK, IT DID NOT CAME OUT AND WAS STUCK ON THE WIRE. WHEN THE WIRE WAS ATTEMPTED TO BE REMOVED, IT WAS ALSO UNABLE TO BE WITHDRAWN. THE BALLOON AND THE WIRE WERE REMOVED AS ONE UNIT. THE PROCEDURE WAS COMPLETED WITH THE SAME SIZE COYOTE BALLOON CATHETER AND A V-14 CONTROLWIRE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9395544 ↗
• MalfunctionSep 26, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE VESSEL BELOW THE KNEE. A 2.5MM X 150MM X 150CM COYOTE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, ON INITIAL INFLATION, THE BALLOON RUPTURED. THE DEVICE WAS COMPLETELY REMOVED AND THE PROCEDURE WAS COMPLETED WITH DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS GOOD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9124119 ↗
• MalfunctionJul 10, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MILDLY CALCIFIED SUPERFICIAL FEMORAL ARTERY TO POPLITEAL ARTERY. A 2.5MM X 150MM X 150CM COYOTE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE FIRST INFLATION, IT WAS NOTED THAT THE CONTRAST MEDIA LEAKED AND THE BALLOON RUPTURED. THE DEVICE WAS THEN REMOVED 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 8778203 ↗
• MalfunctionApr 29, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 2.5MM X 150MM X 150CM COYOTE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INFLATION, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8562650 ↗
• MalfunctionMar 29, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURED OCCURRED. THE TARGET LESION WAS LOCATED IN THE NON TORTUOUS AND SEVERELY CALCIFIED POSTERIOR TIBIAL ARTERY. SEVERAL COYOTE BALLOON CATHETERS WERE ADVANCED AND USED DURING THIS PROCEDURE (3.0MM X 220MM X 150CM, 2.5MM X 150MM X 150CM, 2.0MM X 60MM X 150CM AND 3.0MM X 150MM X 150CM) HOWEVER, THE BALLOONS BLEW OUT AT NOMINAL PRESSURE . THE 1ST COYOTE BALLOON RUPTURED ON THE 2ND INFLATION AT 10 ATM. THE 2ND, 3RD AND 4TH COYOTE BALLOONS RUPTURED ON THE1ST INFLATIONS AT 6 ATM. THE PROCEDURE WAS COMPLETED WITH DIFFERENT DEVICE. NO KNOWN PATIENT COMPLICATION WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8464549 ↗
• MalfunctionMar 28, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 70% STENOSED TARGET LESION WAS LOCATED IN THE NON TORTUOUS AND SEVERELY CALCIFIED VESSEL. A 2.5MM X 150MM X 150CM COYOTE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING FIRST INFLATION AT 6 ATMOSPHERES, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT SERIOUS INJURY NOR COMPLICATIONS WERE REPORTED. IT WAS FURTHER REPORTED THAT THE TARGET LESION WAS LOCATED IN THE POSTERIOR TIBIAL ARTERY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8459970 ↗