Coyote™ H74939186200610Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 08714729796732), received between Nov 19, 2018 and Jul 15, 2025 — classified as 1 injury, 10 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (5 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.

• MalfunctionJul 15, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN A NON-TORTUOUS, MODERATELY CALCIFIED ANTERIOR TIBIAL ARTERY. A 2.0MM X 60MM X 150CM COYOTE BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING FIRST INFLATION, THE BALLOON RUPTURED BEFORE REACHING THE RATED BURST PRESSURE (RBP). THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO COMPLICATIONS FOR THE PATIENT AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22512376 ↗
• InjuryFeb 4, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT TIP FRACTURE OCCURRED RESULTING TO PATIENT COMPLICATIONS. THE TARGET LESION WAS LOCATED IN THE MID ANTERIOR TIBIAL ARTERY. A 2.0MM X 60MM X 150CM, COYOTE BALLOON CATHETER WAS USED FOR DILATION. DURING THE PROCEDURE, THE TIP OF THE ANGIOPLASTY BALLOON FRACTURED AND BECAME EMBEDDED IN THE ARTERIAL WALL. A MINOR WIRE PERFORATION WAS NOTED, ACCOMPANIED BY CONTRAST EXTRAVASATION, WHICH RESOLVED BY THE CONCLUSION OF THE PROCEDURE. THE DEVICE WAS SIMPLY REMOVED FROM THE PATIENT IN ONE PIECE, AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. IT WAS FURTHER REPORTED THAT THE GUIDEWIRE PERFORATED THE VESSEL.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Perforation

  MAUDE report 21304752 ↗
• MalfunctionDec 14, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED, AND THE PROCEDURE WAS CANCELLED. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND SEVERELY CALCIFIED VESSEL IN THE LOWER EXTREMITY. A 2.0MM X 60MM X 150CM COYOTE BALLOON CATHETER WAS ADVANCED FOR DILATATION AFTER A 2.5MM X 40MM X 145CM COYOTE ES BALLOON CATHETER FAILED TO CROSS THE LESION. HOWEVER, DURING THE FIRST INFLATION AT 4 ATMOSPHERES FOR 10 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS ABORTED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15983639 ↗
• MalfunctionJun 30, 2021Inflation Problem; Inflation Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 10JUNE2021. IT WAS REPORTED THAT BALLOON INFLATION FAILURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE LOWER EXTREMITY VESSEL. A 2.0MM X 60MM X 150CM COYOTE BALLOON CATHETER WAS ADVANCED FOR DILATION BUT THE BALLOON WOULD NOT INFLATE. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED BALLOON PINHOLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12094389 ↗
• MalfunctionMay 18, 2021Leak/Splash; Leak/Splash

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 28-APR-2021. II WAS REPORTED THAT CONTRAST LEAK OCCURRED. THE PATIENT UNDERWENT BELOW THE KNEE AND SUPERFICIAL FEMORAL ARTERY PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA). THE 80% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED ANTERIOR TIBIAL ARTERY. A 2.0MM X 60MM X 150CM COYOTE BALLOON CATHETER WAS ADVANCED FOR DILATATION. ANGIOGRAPHY SHOWED CONTRAST AGENT LEAKED OUT DURING INFLATION. THE PHYSICIAN SIMPLY PULLED BACK THE DEVICE FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED BALLOON PINHOLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11843341 ↗
• MalfunctionAug 25, 2020Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT CATHETER ENTRAPMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE RIGHT PERONEAL ARTERY. A 2.0MM X 60MM X 150CM COYOTE BALLOON CATHETER WAS ADVANCED FOR TREATMENT; HOWEVER, THE BALLOON WAS STUCK ON A .014 NON-BSC GUIDEWIRE. SUBSEQUENTLY, BOTH BALLOON AND GUIDEWIRE WERE REMOVED TOGETHER AS ONE UNIT. NO PATIENT COMPLICATIONS NOR INJURIES WERE REPORTED. THE CASE WAS ABORTED UNTIL A LATER DATE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10451894 ↗
• MalfunctionMay 20, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA FEMORAL ARTERY. THE 70% STENOSED, 60MMX2MM, CONCENTRIC TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND NON-CALCIFIED POSTERIOR TIBIAL ARTERY. A 2.0MM X 60MM X 150CM COYOTE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, UPON INFLATION AT 8 ATMOSPHERES, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8626193 ↗
• MalfunctionMay 17, 2019Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 2.0 MM X 60 MM X 150 CM COYOTE BALLOON CATHETER WAS SELECTED FOR USE; HOWEVER, THE BALLOON CATHETER SPLIT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8621253 ↗
• 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 8464715 ↗
• MalfunctionMar 29, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURED OCCURED. 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 8464547 ↗
• MalfunctionNov 19, 2018Break; Break

  IT WAS REPORTED THAT A SHAFT BREAK OCCURRED. DURING UNPACKING OF A 2.0MM X 60MM X 150CM COYOTE BALLOON CATHETER, IT WAS NOTED THAT IT'S END WAS BROKEN. THE DEVICE WAS NOT USED INSIDE THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED. DEVICE EVALUATED BY MANUFACTURER: THE RETURNED PRODUCT CONSISTED OF A COYOTE BALLOON CATHETER IN ONE PIECE. THE BALLOON WAS LOOSELY FOLDED. THE OUTER SHAFT, INNER SHAFT, BALLOON AND TIP WERE MICROSCOPICALLY EXAMINED. THE SHAFT IS KINKED AT THE PROXIMAL BALLOON WAIST. INSPECTION OF THE REMAINDER OF THE DEVICE PRESENTED NO OTHER DAMAGE OR IRREGULARITIES. THERE WAS NO EVIDENCE OF ANY DAMAGE OR IRREGULARITIES CONTRIBUTING TO THE REPORTED EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 8084772 ↗