Ranger™ H74939419501010Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 08714729975984), received between Jan 4, 2022 and Sep 14, 2026 — classified as 7 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Entrapment of Device” (3 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjurySep 14, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Vascular Dissection

  MAUDE report 50762321 ↗
• MalfunctionSep 8, 2025Material 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 5.0 X 100MM, 135CM RANGER DRUG-COATED BALLOON WAS ADVANCED FOR DILATION. HOWEVER, DURING THE FIRST INFLATION AT 6 ATMOSPHERES FOR 5 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED 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 22997134 ↗
• InjuryOct 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT RESTENOSIS OCCURRED. ON (B)(6) 2024, VASCULAR ACCESS WAS OBTAINED VIA RIGHT GROIN USING A 4F SHEATH. SUBSEQUENTLY, THE SHEATH WAS EXCHANGED TO 45CM 6F SHEATH. THE POPLITEAL ARTERY WAS PRE-DILATED USING A 2X60MM COYOTE BALLOON CATHETER AT 14 ATMOSPHERES (ATM) FOR 15 SECONDS TWICE, AND ANOTHER 14 ATM FOR 30 SECONDS. A 4X100MM NON-BOSTON SCIENTIFIC (BSC) BALLOON WAS ADVANCED, AND THE POPLITEAL ARTERY WAS AGAIN PRE-DILATED AT 8 ATM FOR 30 SECONDS AND THEN 14 ATM FOR 30 SECONDS. THE SUPERFICIAL FEMORAL ARTERY (SFA) WAS PRE-DILATED AT 14 ATM FOR 30 SECONDS. THE POPLITEAL WAS THEN DILATED USING THE 5.0 X 100MM, 135CM RANGER PACLITAXEL-COATED PTA BALLOON CATHETER AT 14 ATM FOR 180 SECONDS. A 7X60MM NON-BSC STENT WAS DEPLOYED IN THE SFA AND WAS POST DILATED TWICE USING 5X40MM NON-BSC BALLOON AT 14 ATM FOR 12 SECONDS. THE PROCEDURE WAS COMPLETED. THE PATIENT WAS TRANSFERRED IN STABLE CONDITION. ON (B)(6) 2024, A 6F CONTRALATERAL SHEATH WAS INSERTED OVER THE NON-BSC GUIDEWIRE INTO THE LEFT FEMORAL ARTERY AROUND THE ILIAC BIFURCATION TO THE RIGHT FEMORAL. THE CATHETER WAS ASPIRATED AND FLUSHED, AND A NON-BSC SUPPORT CATHETER WAS INSERTED OVER THE GUIDEWIRE. THE GUIDEWIRE W

  Patient problems: Restenosis

  MAUDE report 20462233 ↗
• InjurySep 4, 2024Failure to Deflate; Failure to Deflate

  IT WAS REPORTED THAT THE BALLOON FAILED TO DEFLATE, REQUIRING ADDITIONAL DEVICE FOR REMOVAL. THE 75% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS SUPERFICIAL FEMORAL ARTERY. A 5.0 X 100MM, 135CM RANGER PACLITAXEL-COATED PTA BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON HAS DEFLATION PROBLEM. THE BALLOON WAS DIRECTLY PUNCTURED OUTSIDE THE BODY TO PERFORMED FORCED DEFLATION. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20140616 ↗
• MalfunctionApr 17, 2024Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT THE CATHETER GOT STUCK WITH THE GUIDEWIRE. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 5.0 X 100MM, 135CM RANGER DRUG-COATED BALLOON WAS SELECTED FOR USE IN A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE. DURING THE PROCEDURE, THE BALLOON CATHETER BECAME ENTRAPPED ON A NON-BSC GUIDEWIRE. THE DEVICES WERE REMOVED TOGETHER. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19125772 ↗
• InjurySep 26, 2023Failure to Deflate; Failure to Deflate

  IT WAS REPORTED THAT THE BALLOON FAILED TO DEFLATE. A 5.0 X 100MM, 135CM RANGER PACLITAXEL-COATED PTA BALLOON CATHETER WAS SELECTED FOR USE IN A LEG ANGIOGRAM TO TREAT PERIPHERAL ARTERIAL DISEASE. THE RANGER WAS SUCCESSFULLY INFLATED TO NOMINAL PRESSURE FOR THREE MINUTES IN THE POPLITEAL ARTERY AND REMOVED. THEN A NON-BOSTON SCIENTIFIC STENT WAS DEPLOYED. THE RANGER WAS AGAIN USED TO POST-DILATE; HOWEVER, IT WOULD NOT DEFLATE. THE BALLOON WAS WALKED OUT TO PROXIMAL TO THE STENT, BUT IT WOULD STILL NOT COMPLETELY DEFLATE. THE PHYSICIAN THEN ATTEMPTED TO POP THE BALLOON WITH A MICRONEEDLE AND APPLY NEGATIVE PRESSURE. AFTER APPROXIMATELY 15 MINUTES OF TRYING TO DEFLATE, THE BALLOON WAS REPLACED WITH A DIFFERENT DEVICE TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17821586 ↗
• InjuryMar 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS PATIENT EXPERIENCED ANAPHYLAXIS. THIS RANGER GLOBAL DCB OTW 5.0 X 100MM, 135CM WAS SELECTED FOR USE IN AN ENDOVASCULAR THROMBECTOMY PROCEDURE. THE LESION WAS IN THE SUPERIOR FEMORAL ARTERY (SFA), AND THE LESION CHARACTERISTICS WERE UNKNOWN. THE PATIENT EXPERIENCED ANAPHYLAXIS AFTER THE PROCEDURE WAS COMPLETED. IT WAS NOTED THAT THE PATIENT WAS ALLERGIC TO CONTRAST AGENT AND THAT CARBON DIOXIDE ANGIOGRAPHY WAS PERFORMED THAT DAY. TWO RANGER BALLOONS WERE USED THAT DAY, AND IT WAS UNKNOWN WHETHER THIS WAS CAUSED BY THE RANGER BALLOONS.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 16594205 ↗
• InjurySep 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ELEGANCE CLINICAL TRIAL. IT WAS REPORTED THAT RE-OCCLUSION OCCURRED. THE SUBJECT UNDERWENT TREATMENT WITH THE RANGER DRUG COATED BALLOON AND ELUVIA DRUG ELUTING STENT ON (B)(6) 2022 AS A PART OF THE ELEGANCE CLINICAL TRIAL. THE FIRST TARGET LESION WAS IN THE RIGHT PROXIMAL POPLITEAL ARTERY, RIGHT MID POPLITEAL ARTERY EXTENDING TO RIGHT DISTAL POPLITEAL ARTERY WITH PROXIMAL REFERENCE VESSEL DIAMETER OF 5.0 MM AND DISTAL REFERENCE VESSEL DIAMETER OF 5.0 MM WITH LESION LENGTH OF 90 MM AND 100 % STENOSIS. PRIOR TO TARGET LESION TREATMENT WITH STUDY DEVICE, PRE DILATION WAS PERFORMED USING 5.0 MM X 240 MM AND 3.0 MMX 240 MM NON-BOSTON SCIENTIFIC PTA BALLOONS. TREATMENT OF TARGET LESION WAS PERFORMED BY DILATION WITH STUDY DEVICE, RANGER DRUG COATED BALLOON OF 5.0 MM X 100 MM. FOLLOWING TREATMENT, THE FINAL RESIDUAL STENOSIS WAS NOTED TO BE 10%. THE SECOND TARGET LESION WAS IN THE RIGHT PROXIMAL SUPERFICIAL FEMORAL ARTERY (SFA), RIGHT MID SFA EXTENDING TO RIGHT DISTAL SFA WITH PROXIMAL REFERENCE VESSEL DIAMETER OF 6.0 MM AND DISTAL REFERENCE VESSEL DIAMETER OF 6.0 MM WITH LESION LENGTH OF 370 MM AND 100 % STENOSIS. PRIOR TO TARGET LESION TREATMENT WITH STUDY DEVICE, PRE DILATION WAS PERF

  Patient problems: Arteriosclerosis/ Atherosclerosis; Movement Disorder; Obstruction/Occlusion

  MAUDE report 15336938 ↗
• InjuryMay 5, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6) CLINICAL TRIAL: IT WAS REPORTED THAT ACUTE THROMBOSIS OCCURRED. THE SUBJECT UNDERWENT TREATMENT WITH THE RANGER DRUG COATED BALLOON AND ELUVIA DRUG ELUTING STENT ON (B)(6) 2022 AS A PART OF THE (B)(6) CLINICAL TRIAL. THE TARGET LESION #001 WAS IN THE RIGHT PROXIMAL POPLITEAL ARTERY, RIGHT MID POPLITEAL ARTERY EXTENDING TO THE RIGHT DISTAL POPLITEAL ARTERY WITH PROXIMAL REFERENCE VESSEL DIAMETER OF 5.0 MM AND DISTAL REFERENCE VESSEL DIAMETER OF 5.0 MM WITH LESION LENGTH OF 90 MM AND 100 % STENOSIS. PRIOR TO TARGET LESION TREATMENT, PRE DILATION WAS PERFORMED USING A 5.0 MM X 240 MM NON-BOSTON SCIENTIFIC PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON. TREATMENT OF THE TARGET LESION WAS PERFORMED BY DILATION WITH STUDY DEVICE, RANGER DRUG COATED BALLOON OF 5.0 MM X 100 MM. FOLLOWING TREATMENT, THE FINAL RESIDUAL STENOSIS WAS NOTED TO BE 20%. THE TARGET LESION #002 WAS IN THE RIGHT PROXIMAL SUPERFICIAL FEMORAL ARTERY, RIGHT MID SUPERFICIAL FEMORAL ARTERY EXTENDING TO RIGHT DISTAL SUPERFICIAL FEMORAL ARTERY WITH PROXIMAL REFERENCE VESSEL DIAMETER OF 6.0 MM AND DISTAL REFERENCE VESSEL DIAMETER OF 6.0 MM WITH LESION LENGTH OF 370 MM AND 100 % STENOSIS. PRIOR TO TARGET LESION T

  Patient problems: Thrombosis/Thrombus

  MAUDE report 14289440 ↗
• MalfunctionFeb 14, 2022Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT THE BALLOON CATHETER BECAME ENTRAPPED ON THE GUIDEWIRE. THE 95% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 5.0 X 100MM, 135CM RANGER BALLOON CATHETER WAS SELECTED FOR THE ENDOVASCULAR THERAPY PROCEDURE. THE RANGER BALLOON WAS DELIVERED WITH A NON-BOSTON SCIENTIFIC GUIDEWIRE AND BECAME ENTRAPPED BEFORE REACHING THE LESION. THE BALLOON WAS REMOVED SEPARATELY FROM THE GUIDEWIRE. THE BALLOON AND THE GUIDEWIRE WERE REPLACED AND THE PROCEDURE WAS COMPLETED WITH DIFFERENT DEVICES. THERE WERE NO REPORTED PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13525370 ↗
• MalfunctionFeb 14, 2022Failure to Advance; Material Integrity Problem; Failure to Advance; Material Integrity Problem

  IT WAS REPORTED COATING PEELED OFF. DURING A SUPERFICIAL FEMORAL ARTERY (SFA) OCCLUSION CASE, A 5.0 X 100MM, 135CM RANGER DRUG-COATED BALLOON (DCB) WAS SELECTED FOR USE. MULTIPLE ATTEMPTS WERE MADE TO CROSS THE LESION WITH THE RANGER, BUT IT WAS UNSUCCESSFUL EVEN AFTER THE LESION WAS DILATED. THE DEVICE WAS INSERTED INSIDE THE PATIENT TWICE, AND THERE WAS A CONCERN THAT THE DRUG COATING MIGHT HAVE PEELED OFF. ANOTHER 5MM X 150MM RANGER DCB WAS OPENED, AND THE PROCEDURE WAS COMPLETED AFTER CROSSING THE LESION. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13522296 ↗
• MalfunctionJan 4, 2022Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT THE BALLOON CATHETER BECAME ENTRAPPED ON THE GUIDEWIRE. A 5.0 X 100MM X 135CM RANGER DRUG-COATED BALLOON WAS SELECTED FOR USE IN A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE. THE TARGET LESION WAS MILDLY TORTUOUS AND CALCIFIED, 50% STENOSED AND LOCATED IN THE SUPERFICIAL FEMORAL ARTERY (SFA). DURING THE PROCEDURE THE BALLOON CATHETER BECAME ENTRAPPED ON THE GUIDEWIRE. THE BALLOON AND GUIDEWIRE WERE REMOVED TOGETHER FROM THE PATIENT. THE DEVICE WAS EXCHANGED FOR A NEW RANGER BALLOON. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13155921 ↗