Coyote™ H74939186402210Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 08714729796671), received between Dec 5, 2019 and Mar 10, 2026 — classified as 1 injury, 10 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (10 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 10, 2026Material Rupture

  IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND SEVERELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 4.0MM X 220MM X 150CM COYOTE BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON RUPTURED UPON FIRST INFLATION AT 12 ATMOSPHERES FOR 60 SECONDS. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM, AND 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 24558860 ↗
• InjuryApr 11, 2025Material Rupture; Device Dislodged or Dislocated; Material Rupture; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE BALLOON RUPTURED, MARKERS DETACHED, AND ADDITIONAL INTERVENTION WAS PERFORMED. A 4.0MM X 220MM X 150CM COYOTE BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON RUPTURED. WHILE REMOVING THE BALLOON, BOTH RADIOPAQUE (RO) MARKERS DETACHED FROM THE CATHETER. ONE RO MARKER WENT INTO A SIDE BRANCH OF THE SUPERFICIAL FEMORAL ARTERY (SFA) AND COULD NOT BE RETRIEVED WITH A SNARE. THE OTHER RO MARKER WENT DOWN TO THE POPLITEAL ARTERY WHERE IT WAS SUBSEQUENTLY CONFINED USING A STENT. THE PROCEDURE WAS COMPLETED USING THE ORIGINAL DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 21825706 ↗
• MalfunctionOct 1, 2024Inflation Problem; Material Twisted/Bent; Failure to Deflate; Inflation Problem; Material Twisted/Bent; Failure to Deflate

  IT WAS REPORTED THAT BALLOON DEFLATION ISSUE OCCURRED. A 4.0MM X 220MM X 150CM COYOTE BALLOON CATHETER WAS ADVANCED FOR DILATATION. DURING INFLATION. A PORTION OF THE BALLOON HAD INFLATED, THEN IT LOOKED LIKE IT WAS JUST WIRE, AND THEN A LITTLE PORTION INFLATED. UPON CHECKING, A SEGMENT OF THE BALLOON IS TWISTED, AND ONE SEGMENT OF THE BALLOON WOULD NOT DEFLATE PROPERLY. THE BALLOON WAS PULLED BACK WITHIN THE VESSEL AND THE PRESSURE OF PULLING IT IN THE VESSEL WAS ENOUGH TO DEFLATE THE REMAINDER. THE BALLOON WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20347160 ↗
• MalfunctionDec 11, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 4.0MM X 220MM X 150CM COYOTE BALLOON WAS ADVANCED FOR DILATATION. HOWEVER, UPON INITIAL INFLATION AT 10 ATMOSPHERES FOR 15 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPETED WITH A DIFFERENT DEVICE. NO COMPLICATIONS REPORTED AND THE PATIENT WAS IN GOOD CONDITION AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18301529 ↗
• MalfunctionApr 13, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 70% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED ANTERIOR TIBIAL ARTERY. AFTER A NON-BSC GUIDEWIRE CROSSED THE LESION, A 4.0MM X 220MM X 150CM COYOTE BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING NORMAL SLOW INFLATION AT 7 ATMOSPHERES, THE BALLOON BURST. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16734446 ↗
• MalfunctionNov 28, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED LEFT LEG. A 4.0MM X 220MM X 150CM, OTW COYOTE BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING THE FIRST INFLATION AT 12 ATMOSPHERES, THE BALLOON WAS RUPTURED. THE BALLOON WAS ASPIRATED AND WAS REMOVED INTACT FROM THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH ANOTHER 4 X 220MM COYOTE BALLOON CATHETER. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15870495 ↗
• MalfunctionSep 27, 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 POPLITEAL ARTERY. A 4.0MM X 220MM X 150CM, OTW COYOTE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE FIRST INFLATION AT 10 ATMOSPHERES FOR 5 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED AND COMPLETED THE PROCEDURE WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT CONDITION WAS GOOD POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15494366 ↗
• MalfunctionJun 9, 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 TIBIOPERONEAL TRUNK AND POSTERIOR TIBIAL ARTERY. A 4.0MM X 220MM X 150CM COYOTE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE SECOND INFLATION AT 6 ATMOSPHERES FOR 1 MINUTE, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14643094 ↗
• MalfunctionApr 29, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED RIGHT SUPERFICIAL FEMORAL ARTERY. A 4.0MMX220MMX150CM COYOTE BALLOON CATHETER AND A 4.00MM/1.5CM/140CM SMALL PERIPHERAL CUTTING BALLOON WERE USED TOGETHER. AFTER POSITIONING THE SHEATH, THE LESION WAS CROSSED WITH THE SUPPORT CATHETER, MICRO CATHETER, AND GUIDEWIRE. DILATION WAS PERFORMED USING COYOTE BALLOON, HOWEVER IT RUPTURED IN A PINHOLE FORM SLIGHTLY NEAR THE TIP FROM THE CENTER UPON SECOND INFLATION AT 14ATM FOR 30SECONDS. SUBSEQUENTLY, PCB WAS USED FOR DILATION OF THE RESIDUAL STENOSIS BUT IT ALSO RUPTURED UPON SECOND INFLATION AT 10ATM. THE SAME LESION WAS DILATED USING A PCB OF THE SAME SIZE, AND THE PROCEDURE WAS COMPLETED BY PERFORMING POST WITH OCEANUS 4-200. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14252002 ↗
• MalfunctionDec 15, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA THE CONTRALATERAL APPROACH. THE 75% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MILDLY CALCIFIED LEFT SUPERFICIAL FEMORAL ARTERY. AFTER A 6F NON-BOSTON SCIENTIFIC (BSC) GUIDE CATHETER AND A NON-BSC GUIDE WIRE CROSSED THE LESION, PRE-DILATION WAS PERFORMED WITH A 3X200 NON-BSC BALLOON CATHETER AND WAS REPLACED WITH A 4.0MM X 220MM X 150CM COYOTE BALLOON CATHETER FOR SIZE UP. HOWEVER, DURING THE SECOND INFLATION AT 14 ATMOSPHERES FOR 120 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED FROM THE PATIENT WITHOUT PROBLEM AND PINHOLE ON THE TIP SIDE OF THE BALLOON WAS NOTED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS WAS GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13007909 ↗
• MalfunctionDec 5, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY. A 4.0MM X 220MM X 150CM COYOTE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, UPON INFLATION AT 12 ATMOSPHERES FOR 2 MINUTES, THE BALLOON WAS DEFLATING AND IT POPPED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS NOR INJURIES WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9419734 ↗