Coyote™ H74939186302210Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 08714729797265), received between Mar 29, 2019 and Feb 3, 2026 — classified as 21 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (15 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 3, 2026Entrapment of Device; Adverse Event Without Identified Device or Use Problem; Poor Visibility

  IT WAS REPORTED THAT FROZE ON WIRE OCCURRED. THE 65% STENOSED TARGET LESION WAS LOCATED IN THE MILD TORTUOUS AND MILD CALCIFIED VESSEL IN THE RIGHT LEG. A 3.0MM X 220MM X 150CM COYOTE WAS SELECTED FOR USE. DURING THE PROCEDURE, A .014 NON BOSTON SCIENTIFIC GUIDEWIRE WAS ADVANCED FROM AN UP AND OVER APPROACH THROUGH A NON BOSTON SCIENTIFIC SHEATH. A .014 NON-BOSTON SCIENTIFIC IVUS CATHETER WAS LOADED BUT WOULD NOT ADVANCE THROUGH THE LESION. THE IVUS CATHETER WAS REMOVED. THE COYOTE WAS ADVANCED FOR DILATION. IT WAS NOTED THAT THERE WERE NO BALLOON MARKER-BANDS SHOWING UP ON THE X-RAY SCREEN. THE PHYSICIAN MOVED THE X-RAY NORTH, TOWARDS THE HEAD AND NOTICED THAT THE WIRE HAD PROLAPSED ON ITSELF AND THE BALLOON WAS NOT ADVANCING. UPON ATTEMPTING TO REMOVE THE BALLOON, IT WOULD NOT COME OUT OF THE BODY WITHOUT TAKING THE NON-BOSTON WIRE WITH IT. AFTER REMOVAL, IT WAS OBSERVED THAT THE BALLOON WAS FUSED TO THE WIRE AND WOULD NOT COME OUT, EVEN WITH EXCESSIVE FORCE. THE PROCEDURE WAS COMPLETED WITH ALTERNATE DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24249169 ↗
• MalfunctionNov 17, 2025Inflation Problem; Inflation Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 28OCT2025. IT WAS REPORTED THAT BALLOON FAILED TO EXPAND WELL IN THE LESION. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED VESSEL BELOW THE KNEE. A 3.0MM X 220MM X 150CM COYOTE BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, IT WAS NOTED THAT THE BALLOON FAILED TO EXPAND WELL IN THE LESION. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. HOWEVER, DEVICE ANALYSIS REVEALED A PINHOLE 108MM FROM THE TIP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23566795 ↗
• MalfunctionMay 12, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED POPLITEAL ARTERY. A 3.0MM X 220MM X 150CM COYOTE BALLOON CATHETER WAS ADVANCED OVER THE WIRE FOR PERIPHERAL VASCULAR DISEASE. DURING THE PROCEDURE, THE BALLOON BURST. THE DEVICE WAS REMOVED FROM THE PATIENT WITHOUT ANY FRAGMENTS LEFT, AND THE PROCEDURE WAS COMPLETED USING ALTERNATE METHOD. THERE WAS NO PATIENT COMPLICATIONS NOTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22003496 ↗
• MalfunctionFeb 26, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON BURST OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND SEVERELY CALCIFIED RIGHT LOWER EXTREMITY. A 3.0MM X 220MM X 150CM COYOTE BALLOON WAS ADVANCED FOR DILATION. HOWEVER, DURING THE FIRST INFLATION AT 14 ATMOSPHERES FOR 10 SECONDS, THE BALLOON BURST. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH A 3X 150 COYOTE BALLOON. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21467759 ↗
• MalfunctionFeb 19, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND SEVERELY CALCIFIED TIBIAL VESSEL. A 3.0MM X 220MM X 150CM, OTW COYOTE BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING FIRST INFLATION AT 10 ATMOSPHERES FOR 60 SECONDS, THE BALLOON BURST. THE DEVICE WAS REMOVED OVER THE WIRE INTACT, AND 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 21412682 ↗
• MalfunctionDec 4, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 95% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MILDLY CALCIFIED ANTERIOR TIBIAL ARTERY (ATA). AFTER THE DILATATION WAS PERFORMED IN THE LEFT POPLITEAL ARTERY WITH 3.0MM X 220MM X 150CM COYOTE BALLOON CATHETER, THE ATA WAS ATTEMPTED TO BE DILATED. AFTER CROSSING THE LESION, THE BALLOON WAS INITIALLY INFLATED AT 6 ATMOSPHERES FOR 10 SECONDS. HOWEVER, IT RUPTURED BEFORE REACHING THE NOMINAL PRESSURE. THE DEVICE WAS REMOVED FROM THE SHEATH WITHOUT ANY PROBLEMS, AND THE PROCEDURE WAS COMPLETED USING A DIFFERENT BALLOON. NO COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20843823 ↗
• MalfunctionJun 11, 2024Entrapment of Device; Difficult to Advance; Material Integrity Problem; Entrapment of Device; Difficult to Advance; Material Integrity Problem

  IT WAS REPORTED THAT FROZE ON WIRE OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MILD TORTUOUS AND MILD CALCIFIED ANTERIOR TIBIAL ARTERY. A 3.0MM X 220MM X 150CM COYOTE BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, IT WAS FOUND THAT THE SHAFT WAS CRIMPED. THE BALLOON WAS ADVANCED AND INFLATED AT 8ATM FOR 2 MINUTES. THE DEVICE WAS WITHDRAWN AND REINSERTED AFTER LASER ATHERECTOMY ON WIRE. HOWEVER, THE BALLOON WOULD NOT TRACK OVER WIRE AND WIRE COULD NOT BE REMOVED EITHER. THE WIRE AND BALLOON WERE REMOVED FROM THE PATIENT INTACT AND FULLY DEFLATED AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19508788 ↗
• MalfunctionMay 1, 2024Leak/Splash; Failure to Advance; Leak/Splash; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2024. IT WAS REPORTED THAT BALLOON DID NOT CROSS AND WAS LEAKING. A 3.0MM X 220MM X 150CM, OTW COYOTE WAS ADVANCED FOR DILATATION. HOWEVER, UPON ADVANCING, THE BALLOON DID NOT CROSS, AND IT WAS LEAKING. THERE WERE NO PATIENT COMPLICATIONS REPORTED. HOWEVER, DEVICE ANALYSIS REVEALED THAT A PINHOLE AT 1MM FROM THE TIP OF THE BALLOON WAS NOTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19221993 ↗
• MalfunctionApr 11, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND MODERATELY CALCIFIED VESSEL BELOW-THE-KNEE. A 3.0MM X 220MM X 150CM, OTW COYOTE BALLOON CATHETER WAS ADVANCED FOR DILATATION. THE BALLOON INFLATED THREE TIMES AT 12 ATMOSPHERES IN 10 SECONDS FOR THE SAME. HOWEVER, DURING THE THIRD INFLATION, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS REPORTED. THE PATIENT CONDITION WAS GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16718196 ↗
• MalfunctionFeb 1, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE PATIENT WAS PRESENTED WITH POPLITEAL ARTERY STENOSIS AND UNDERWENT POPLITEAL ANGIOPLASTY. THE 100% STENOSED TARGET LESION WAS LOCATED IN NON-TORTUOUS AND MODERATELY CALCIFIED POPLITEAL ARTERY. A 3.0MM X 220MM X 150CM COYOTE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, WHEN THE DEVICE WAS INFLATED AT 8 ATMOSPHERES FOR 1 MINUTE, LOSS OF PRESSURE WAS OBSERVED UNDER FLUOROSCOPY. THE BALLOON WAS REMOVED, BALLOON LEAK AND A VISIBLE PINHOLE WERE OBSERVED. A METALIC INTRODUCER SHEATH BY ARROW WAS USED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16279795 ↗
• MalfunctionDec 5, 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 SUPERFICIAL FEMORAL ARTERY. A 3.0MM X 220MM X 150CM, OTW COYOTE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE INITIAL INFLATION AT 6 ATMOSPHERES FOR 10 SECONDS, THE BALLOON WAS RUPTURED AT THE DISTAL SIDE. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM AND THE PROCEDURE WAS COMPLETED WITH DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED AND THE PATIENT CONDITION WAS GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15914581 ↗
• MalfunctionJul 29, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE PATIENT PRESENTED WITH PERIPHERAL ARTERIAL DISEASE AND UNDERWENT ENDOVASCULAR THERAPY. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MILDLY CALCIFIED BELOW-THE-KNEE VESSEL. A 3.0MM X 220MM X 150CM COYOTE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE FIRST INFLATION AT 14 ATMOSPHERES FOR 30 SECONDS, THE BALLOON RUPTURED. 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 15130551 ↗
• MalfunctionOct 11, 2021Leak/Splash; Leak/Splash

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 28-SEP-2021. IT WAS REPORTED THAT BALLOON LEAK OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE CALCIFIED AND NON-TORTUOUS LEFT ANTERIOR TIBIAL ARTERY. A 3.0MM X 220MM X 150CM COYOTE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INFLATION AT 8 ATMOSPHERES, THE BALLOON LEAKED. THE PROCEDURE WAS COMPLETED WITH A 2.5 X 2.20 COYOTE BALLOON CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED. IT WAS FURTHER REPORTED THAT THERE WAS NO VISIBLE PINHOLE NOTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED BALLOON PINHOLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12609939 ↗
• MalfunctionMar 5, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 3.0MM X 220MM X 150CM COYOTE BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING INFLATION AT MINIMAL INFLATION, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED. IT WAS FURTHER REPORTED THAT THE TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND VERY CALCIFIED DISTAL POPLITEAL INTO POST TIBIAL ARTERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11419021 ↗
• MalfunctionNov 23, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 70% STENOSED TARGET LESION WAS LOCATED IN NON-TORTUOUS AND HEAVILY CALCIFIED ANTERIOR TIBIAL ARTERY. A 3.0MM X 220MM X 150CM COYOTE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING FIRST INFLATION, THE BALLOON RUPTURED AT NOMINAL PRESSURE. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10883523 ↗
• MalfunctionApr 1, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE TIBIAL VESSEL. A 3.0MM X 220MM X 150CM AND A 2.5MM X 220MM X 150CM COYOTE BALLOON CATHETERS WERE ADVANCED CONSECUTIVELY FOR DILATATION. HOWEVER, DURING THE FIRST INFLATION AT 10 ATMOSPHERES, THE BALLOONS RUPTURED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9912451 ↗
• MalfunctionMar 18, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED VESSEL BELOW THE KNEE. AFTER A GUIDE WIRE CROSSED THE LESION, A 3.0MMX220MMX150CM COYOTE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INFLATION, THE BALLOON RUPTURED. DILATATION WAS PERFORMED USING A NON-BSC BALLOON AND THE PROCEDURE WAS CONTINUED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9849226 ↗
• MalfunctionDec 30, 2019Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT CATHETER ENTRAPMENT OCCURRED. A 3.0MM X 220MM X 150CM COYOTE BALLOON CATHETER WAS SELECTED FOR USE. HOWEVER, IT WAS NOTED THAT THE BALLOON HAD DIFFICULTIES ADVANCING ON THE WIRE AND WAS DESCRIBED TO BE STIFF. THE BALLOON COULD NOT MOVE AND WAS SUBSEQUENTLY STUCK ON THE WIRE. THE BALLOON AND THE WIRE WERE REMOVED TOGETHER AND NO KNOWN PATIENT COMPLICATIONS WERE REPORTED. IT WAS FURTHER REPORTED THAT THE TARGET LESION WAS LOCATED IN THE TIBIAL ARTERY AND THE PROCEDURE WAS COMPLETED WITH A NEW BALLOON AND WIRE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9528930 ↗
• MalfunctionAug 7, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 90% TO 95% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED VESSEL IN LEFT LOWER LEG. TWO 2.0MM X 220MM X 150CM COYOTE BALLOON CATHETER AND A 3.0MM X 220MM X 150CM COYOTE BALLOON CATHETER WERE USED FOR DILATATION CONSECUTIVELY. HOWEVER, DURING THE FIRST INFLATION BEFORE REACHING THE NOMINAL PRESSURE, THE BALLOONS RUPTURED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED AND THE PATIENT WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8870935 ↗
• MalfunctionJun 4, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR TIBIAL ARTERY. A 3.0MM X 220MM X 150CM COYOTE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING FIRST INFLATION BEFORE REACHING NOMINAL PRESSURE, THE BALLOON RUPTURED. THE DEVICE WAS COMPLETELY REMOVED FROM THE PATIENT'S BODY AND 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 8669132 ↗
• 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 8464324 ↗