Coyote™ H74939186401510Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 08714729796664), received between Nov 22, 2018 and Sep 2, 2024 — classified as 1 injury, 10 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (9 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 2, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED RIGHT SUPERFICIAL FEMORAL ARTERY. A 4.0MM X 150MM X 150CM COYOTE BALLOON CATHETER WAS ADVANCED FOR DILATATION. DURING THE PROCEDURE, THE BALLOON RUPTURED UPON FIRST INFLATION AT 6 ATMOSPHERES FOR 5 SECONDS. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM, AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO COMPLICATIONS REPORTED, AND THE PATIENT WAS IN GOOD CONDITION AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20118305 ↗
• MalfunctionMar 28, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED LEFT SUPERFICIAL FEMORAL ARTERY. A 4.0MM X 150MM X 150CM COYOTE BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON RUPTURED UPON SECOND INFLATION AT 10 ATMOSPHERES FOR 30 SECONDS. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM, AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS IN GOOD CONDITION AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19000089 ↗
• MalfunctionSep 26, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A RUPTURE OCCURRED. A 2.0MM X 220MM X 150CM COYOTE AND A 4.0MM X 150MM X 150CM COYOTE WERE SELECTED FOR USE. DURING THE PROCEDURE, THE DEVICES RUPTURED. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15486536 ↗
• InjuryMay 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ELEGANCE CLINICAL TRIAL . IT WAS REPORTED THAT AN EMBOLISM OCCURRED. THE SUBJECT UNDERWENT TREATMENT WITH THE RANGER DRUG COATED BALLOON (DCB) ON (B)(6) 2022 AS A PART OF THE ELEGANCE CLINICAL TRIAL. THE TARGET LESION #001 WAS IN THE RIGHT MID SUPERFICIAL FEMORAL ARTERY (SFA) EXTENDING UP TO THE RIGHT DISTAL SFA. THE LESION HAD 5.0MM PROXIMAL REFERENCE VESSEL DIAMETER AND 5.0MM DISTAL REFERENCE VESSEL DIAMETER WITH A LESION LENGTH OF 200MM. THE LESION WAS 80% STENOSED AND WAS CLASSIFIED AS A TASC II B LESION. PRIOR TO TARGET LESION TREATMENT, TREATMENT WAS PERFORMED BY PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY USING A 4.0MM X 150MM COYOTE BALLOON. TREATMENT OF THE TARGET LESION WAS PERFORMED BY DILATATION WITH A 5.0MM X 200MM RANGER DCB STUDY DEVICE. FOLLOWING POST DILATATION, ASPIRATION THROMBECTOMY WAS PERFORMED WITH A NON BOSTON SCIENTIFIC DEVICE. THE FINAL RESIDUAL STENOSIS WAS NOTED TO BE 20%. DURING THE TREATMENT OF THE TARGET LESION #001, AN EMBOLISM WAS NOTED WITH RESIDUAL STENOSIS NOTED TO BE 20%. IN RESPONSE TO THE OBSERVED EMBOLISM, ASPIRATION THROMBECTOMY WAS PERFORMED. THE EMBOLISM WAS RESOLVED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: Embolism/Embolus

  MAUDE report 14338629 ↗
• MalfunctionNov 24, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE PATIENT PRESENTED WITH SEVERE LOWER LIMB ISCHEMIA. THE 95% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 4.0MM X 150MM X 150CM COYOTE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INITIAL INFLATION AT 12 ATMOSPHERES FOR 40 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO REPORTED COMPLICATIONS NOR INJURIES AND THE PATIENT CONDITION WAS GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12867733 ↗
• MalfunctionAug 23, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND SEVERELY CALCIFIED POSTERIOR TIBIAL ARTERY. A 4.0MM X 150MM X 150CM COYOTE BALLOON CATHETER WAS ADVANCED FOR POST DILATATION. HOWEVER, DURING INITIAL INFLATION AT 10 ATMOSPHERES FOR 10 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS PULLED OUT FROM THE PATIENT'S BODY AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12354666 ↗
• MalfunctionAug 11, 2021Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT CATHETER ENTRAPMENT ON GUIDEWIRE OCCURRED. THE TARGET LESION WAS LOCATED IN SUPERFICIAL FEMORAL ARTERY. A 4.0MM X 150MM X 150CM COYOTE BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING INFLATION, IT WAS NOTED THAT THE BALLOON SHOW SIGNS OF CRIMPING AND IT WAS STUCK TO THE WIRE. THE PROCEDURE WAS COMPLETED AND THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12306898 ↗
• MalfunctionJan 25, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURED OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE POPLITEAL ARTERY. A 4.0MM X 150MM X 150CM COYOTE BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING INFLATION, THE BALLOON BURST. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICAITONS AND THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11224366 ↗
• MalfunctionJul 28, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TOTALLY OCCLUDED TARGET LESION WAS LOCATED IN THE NON- TORTUOUS AND SEVERELY CALCIFIED RIGHT SUPERFICIAL FEMORAL ARTERY. A 4.0MM X 150MM X 150CM COYOTE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE FIRST INFLATION AT 10 ATMOSPHERES, THE BALLOON RUPTURED. THE DEVICE WAS RETRIEVED FROM THE PATIENT'S BODY AND THE PROCEDURE WAS COMPLETED WITH A STERLING BALLOON CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS DOING WELL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10335039 ↗
• MalfunctionApr 6, 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 LEFT SUPERFICIAL FEMORAL ARTERY. A 4.0MM X 150MM X 150CM COYOTE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE SECOND INFLATION AT 14 ATMOSPHERES FOR 10 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9929440 ↗
• MalfunctionNov 22, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS POPLITIAL ARTERY. A 4.0MM X 150MM X 150CM COYOTE BALLOON CATHETER WAS ADVANCED FOR PRE-DILATATION. HOWEVER, DURING SECOND INFLATION THE BALLOON RUPTURED. THE DEVICE WAS COMPLETELY REMOVED FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH A 4MM PERIPHERAL CUTTING BALLOON. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8098950 ↗