Ranger™ H74939419401510Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 08714729975861), received between Oct 4, 2021 and Sep 25, 2025 — classified as 6 injuries, 8 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjurySep 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT RESTENOSIS OCCURRED, REQUIRING INTERVENTION. ON (B)(6) 2024, THE SUBJECT UNDERWENT TREATMENT WITH THE RANGER DRUG COATED BALLOON AS A PART OF THE CLINICAL TRIAL. THE TARGET LESION #001 WAS IN THE LEFT MID POPLITEAL ARTERY WITH 4 MM PROXIMAL REFERENCE VESSEL DIAMETER AND 4 MM DISTAL REFERENCE VESSEL DIAMETER WITH 20 MM LESION LENGTH WITH 90% STENOSIS AND WAS CLASSIFIED AS TRANSATLANTIC INTERSOCIETY CONSENSUS (TASC) II CLASS NOT APPLICABLE. TREATMENT OF TARGET LESION WAS PERFORMED BY DILATION USING 4 MM X 150 MM RANGER DRUG COATED BALLOON, STUDY DEVICE. POST PROCEDURE, THE FINAL RESIDUAL STENOSIS WAS NOTED TO BE 10%. ON THE SAME DAY, THE SUBJECT WAS DISCHARGED FROM THE HOSPITAL ON CLOPIDOGREL. ON (B)(6) 2025, THE SUBJECT UNDERWENT LEFT LOWER ARTERIAL DUPLEX WHICH REVEALED PATENT LEFT LOWER EXTREMITY ARTERIES WITH SEVERE STENOSIS OF THE POPLITEAL ARTERY AND POSSIBLE PROXIMAL TO MID SFA STENOSIS. THE LEFT LOWER EXTREMITY WAVEFORMS AND PRESSURES SUGGESTED FEMOROPOPLITEAL DISEASE. ANKLE BRACHIAL INDEX (ABI) WAS NOTED TO BE 1.26 AND 0.77 ON RIGHT AND LEFT LEG RESPECTIVELY AND TOE BRACHIAL INDEX WAS NOTED TO BE 0.76 AND 0.65 ON RIGHT AND LEFT LEG RESPECTIVELY. ABI OF L

  Patient problems: Restenosis

  MAUDE report 23148480 ↗
• InjurySep 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IIT WAS REPORTED THAT OCCLUSION WAS NOTED, REQUIRING INTERVENTION. ON (B)(6) 2024, THE SUBJECT UNDERWENT TREATMENT WITH THE RANGER DRUG COATED BALLOON AS A PART OF THE CLINICAL TRIAL. THE TARGET LESION #001 WAS IN THE LEFT MID POPLITEAL ARTERY WITH 4 MM PROXIMAL REFERENCE VESSEL DIAMETER AND 4 MM DISTAL REFERENCE VESSEL DIAMETER WITH 20 MM LESION LENGTH WITH 90% STENOSIS. TREATMENT OF TARGET LESION WAS PERFORMED BY DILATION USING 4 MM X 150 MM RANGER DRUG COATED BALLOON, STUDY DEVICE. POST PROCEDURE, THE FINAL RESIDUAL STENOSIS WAS NOTED TO BE 10%. ON THE SAME DAY, THE SUBJECT WAS DISCHARGED FROM THE HOSPITAL ON CLOPIDOGREL. ON (B)(6) 2024, THE SUBJECT UNDERWENT LEFT LOWER ARTERIAL DUPLEX WHICH REVEALED LEFT FEMOROPOPLITEAL DISEASE. THE LEFT LOWER EXTREMITY WAVEFORMS AND PRESSURES SUGGESTED TIBIAL DISEASE. ANKLE BRACHIAL INDEX (ABI) WAS NOTED TO BE 1.19 AND 0.85 ON RIGHT AND LEFT LEG RESPECTIVELY AND TOE BRACHIAL INDEX WAS NOTED TO BE 0.4 AND 0.26 ON RIGHT AND LEFT LEG RESPECTIVELY. ABI OF LEFT LEG WAS CONSISTENT WITH MILD ARTERIAL OCCLUSIVE DISEASE WITH SIGNIFICANT DROP IN ANKLE PRESSURES POST EXERCISE AND ABI OF RIGHT LEG WAS NOTED TO BE NORMAL WITH NO SIGNIFICANT DROP IN ANKLE P

  Patient problems: Obstruction/Occlusion; Restenosis

  MAUDE report 23136867 ↗
• MalfunctionDec 5, 2024Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT DEVICE BECAME STUCK WITH THE WIRE. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED RIGHT SUPERFICIAL FEMORAL ARTERY. A 4.0 X 150MM, 150CM RANGER DRUG-COATED BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE DEVICE BECAME STUCK WITH THE 0.018 NON-BOSTON SCIENTIFIC GUIDEWIRE. BOTH DEVICES WERE REMOVED AS A SINGLE UNIT, AND EVENTUALLY THE WIRE WAS REMOVED FROM THE CATHETER OUTSIDE THE BODY. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20856373 ↗
• MalfunctionAug 13, 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 SUPERFICIAL FEMORAL ARTERY (SFA) WITH A SIMPLE CURVATURE GENERAL GEOMETRY. AFTER INFLATION WAS PERFORMED WITH A 4MM NON-BOSTON SCIENTIFIC (BSC) DEVICE IN AN SFA DISTAL OCCLUSION CASE, A 4.0 X 150MM, 150CM RANGER PACLITAXEL-COATED PTA BALLOON CATHETER WAS ADVANCED THROUGH THE SHEATH USING THE LOADING TOOL. DURING THE PROCEDURE, THE BALLOON RUPTURED WHEN IT REACHED 6 ATMOSPHERES UPON INITIAL INFLATION. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEMS, AND THE PROCEDURE WAS COMPLETED WITH A NON-BSC 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 19973450 ↗
• MalfunctionJun 6, 2024Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT GUIDEWIRE STUCK OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED VESSEL. A 4.0 X 150MM, 150CM RANGER PACLITAXEL-COATED PTA BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, IT WAS NOTED THAT THE BALLOON GOT STUCK WITH THE GUIDEWIRE. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME 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 19477678 ↗
• MalfunctionSep 15, 2023Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT SLOW DEFLATION OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED SUPERFICIAL FEMORAL ARTERY (SFA). A 4.0 X 150MM, 150CM RANGER PACLITAXEL-COATED PTA BALLOON CATHETER WAS SELECTED FOR USE. DURING THE PROCEDURE, THE DEFLATION WAS VERY SLOW. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17756303 ↗
• MalfunctionMay 24, 2023Leak/Splash; Material Rupture; Leak/Splash; Material Rupture

  IT WAS REPORTED THAT THE BALLOON RUPTURED AND HAD A PINHOLE. THIS RANGER GLOBAL DCB OTW 4.0 X 150MM, 150CM WAS SELECTED FOR USE IN A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE. THE LESION WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY (SFA) AND WAS 90% STENOSED, MODERATELY TORTUOUS, AND MODERATELY CALCIFIED. THE CENTER PART OF THE BALLOON RUPTURED AND HAD A PINHOLE WHICH WAS NOTED DURING THE FIRST INFLATION AT 6 ATMOSPHERES FOR 10 SECONDS. THE DEVICE WAS ABLE TO BE REMOVED INTACT, THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE, AND THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16991818 ↗
• InjuryApr 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT RESTENOSIS OCCURRED. THIS RANGER PACLITAXEL-COATED PTA BALLOON CATHETER 4.0 X 2150MM, 150CM WAS SELECTED FOR USE IN THIS LEFT LOWER EXTREMITY ARTERIOGRAM FOR PERIPHERAL VASCULAR DISEASE WITH NON-HEALING LEFT FOOT WOUND. THE TARGET TREATMENT AREAS WERE TIBIOPERONEAL TRUNK AND PROXIMAL PERONEAL ARTERY. FINAL ANGIOGRAM (AFTER CONSECUTIVE TREATMENTS WITH ROTABLATOR TREATMENTS AND ANOTHER MANUFACTURER BALLOON) SHOWED WIDE PATENCY TO THE POPLITEAL, THE TIBIOPERONEAL TRUNK, THE POSTERIOR TIBIAL ARTERY AND THE PERONEAL ARTERY WITH EXCELLENT FLOW TO THE FOOT WITH COLLATERALIZATION TO THE DORSALIS PEDIS. APPROXIMATELY 7 MONTHS POST-TREATMENT, FOLLOW-UP DETERMINED THAT THE WOUND ON THE FOOT HAD STALLED, AND THE PATIENT HAD PROGRESSIVE PAIN. ULTRASOUND STUDY SHOWED RECURRENT SIGNIFICANT DISEASE IN THE FEMORAL-POPLITEAL AND INFRAPOPLITEAL SEGMENTS THREATENING VIABILITY OF THE LIMB. PATIENT WAS BROUGHT IN NOW FOR URGENT ARTERIOGRAM FOR FURTHER EVALUATION AND POSSIBLE INTERVENTION FOR LIMB SALVAGE. A BILATERAL LOWER EXTREMITY ARTERIOGRAM WAS PERFORMED AND REVEALED THAT JUST ABOVE HUNTER'S CANAL THERE WAS SOME TAPERING OF THE DISTAL SUPERFICIAL FEMORAL ARTERY AND THEN SEVERE D

  Patient problems: Pain; Restenosis

  MAUDE report 16832409 ↗
• MalfunctionNov 17, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN A MODERATELY TORTUOUS AND MODERATELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 4.0MM X 150MM, 150CM RANGER PACLITAXEL-COATED PTA BALLOON CATHETER WAS SELECTED FOR THE LOWER EXTREMITY ARTERIAL DISEASE PROCEDURE. DURING THE FIRST INFLATION, HOWEVER, THE BALLOON RUPTURED AT 8 ATMOSPHERES AFTER 5 SECONDS INFLATION TIME. THE BALLOON WAS ABLE TO BE REMOVED USING THE NORMAL METHOD, AND IT WAS REPLACED WITH A NEW RANGER BALLOON TO COMPLETE THE PROCEDURE. 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 15815586 ↗
• InjuryOct 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THERE WAS ISCHEMIA/OCCLUSION OF TREATED RIGHT SUPERFICIAL FEMORAL ARTERY (SFA). ON (B)(6) 2022, A RANGER DRUG-COATED BALLOON WAS USED DURING A TREATMENT PROCEDURE FOR PERIPHERAL ARTERIAL DISEASE WITH CLAUDICATION. UTILIZING ROADMAP IMAGING, A GLIDEWIRE AND RUBICON CROSSING CATHETER WERE ADVANCED THROUGH THE SFA OCCLUSION INTO THE POPLITEAL ARTERY. THE ANTERIOR TIBIA ARTERY ORIGIN WAS THEN SELECTED. THE WIRE AND CATHETER WERE ADVANCED DOWN TO THE DISTAL ANTERIOR TIBIAL ARTERY. INTRALUMINAL POSITION WAS CONFIRMED BY CATHETER INJECTION. ATHERECTOMY OF THE SFA, POPLITEAL AND PROXIMAL ANTERIOR TIBIA ARTERY WAS THEN PERFORMED WITH A ROTABLATOR 2.0 MM ATHERECTOMY DEVICE. BALLOON ANGIOPLASTY WAS THEN PERFORMED, FIRST TO THE ANTERIOR TIBIA ARTERY WITH A 3 X 100 MM BALLOON INFLATED TO FULL PROFILE FOR 3 MINUTES. THE POPLITEAL AND SFA WAS THEN TREATED WITH A 4 X 150 MM RANGER DRUG-COATED BALLOON INFLATED TO FULL PROFILE FOR 3 MINUTES. THE SFA WAS THEN TREATED WITH A 5 X 200 MM BALLOON INFLATED TO FULL PROFILE FOR 3 MINUTES. FINAL IMAGING SHOWED AN EXCELLENT RESULT, WITH NO SIGNIFICANT RESIDUAL STENOSIS END BRISK FLOW TO THE FOOT. ON (B)(6) 2022, THE PATIENT PRESENTED WITH LOWE

  Patient problems: Ischemia; Obstruction/Occlusion

  MAUDE report 15628847 ↗
• InjuryAug 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN OCCLUSION OCCURRED. THE PATIENT RETURNED FOR A FOLLOW-UP AND ARTERIAL DUPLEX EXAM SHOWS A RECURRENT HIGH-GRADE STENOSIS OR OCCLUSION IN THE DISTAL POPLITEAL ARTERY. THEREFORE, ANGIOGRAM IS BEING PERFORMED FOR PLANNED REVASCULARIZATION. ON (B)(6) 2022, THE PATIENT CAME TO COASTAL VEIN AND VASCULAR. THE PATIENT WAS GIVEN A VALIUM AND PERCOCET BY MOUTH FOR SEDATION. CHEM-8 WAS PERFORMED WHICH SHOWED CREATININE1.4 WITH NORMAL ELECTROLYTES AND INTERNATIONAL NORMALIZED RATIO (INR) OF 1.4. IV WAS STARTED FOR HYDRATION AND SHE WAS PLACED SUPINE ON THE FLUOROSCOPY TABLE. BOTH GROINS WERE SHAVED AND PREPPED WITH CHLORAPREP AND DRAPED IN A STERILE FASHION. 1% XYLOCAINE PLAIN WAS USED FOR LOCAL INFILTRATION AND 21-GAUGE MICROPUNCTURE NEEDLE WAS INSERTED IN THE LEFT COMMON FEMORAL ARTERY UNDER ULTRASOUND GUIDANCE. ULTRASOUND GUIDANCE FOR VASCULAR ACCESS WAS USED TO DOCUMENT VESSEL PATENCY WITH CONCURRENT ULTRASOUND VISUALIZATION OF VASCULAR NEEDLE ENTRY AND PERMANENT RECORDING AND REPORTING OF VESSEL PATENCY. GUIDEWIRE WAS INSERTED INTO THE COMMON FEMORAL ARTERY, FOLLOWED BY A 5 FRENCH SHEATH. UNILATERAL ARTERIOGRAM OF LEFT LEG TO THE LEFT COMMON FEMORAL, SUPERFICIAL FEM

  Patient problems: Obstruction/Occlusion

  MAUDE report 15184252 ↗
• MalfunctionDec 17, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THE BALLOON RUPTURED. A 4.0 X 150MM, 150CM RANGER DRUG COATED BALLOON (DCB) WAS BEING USED IN A 99% STENOSED, MODERATELY TORTUOUS AND SEVERELY CALCIFIED SUPERFICIAL FEMORAL ARTERY (SFA) TREATMENT PROCEDURE. DURING THE FIRST INFLATION AT 12ATM, THE BALLOON RUPTURED. THE BALLOON WAS EXCHANGE AND THE PROCEDURE WAS COMPLETED WITH NO PATIENT COMPLICATIONS. PATIENT WAS NOTED IN GOOD CONDITION AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13028079 ↗
• MalfunctionNov 29, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. A 4 MM X 150MM X 150CM RANGER BALLOON WAS SELECTED TO TREAT PERIPHERAL ARTERY DISEASE IN THE SUPERFICIAL FEMORAL ARTERY. THE LESION WAS MODERATELY TORTUOUS, 100% STENOSED AND SEVERELY CALCIFIED. INSIDE THE PATIENT, THE BALLOON WAS INFLATED ONCE TO 14 ATMOSPHERES FOR 30 SECONDS WHEN IT RUPTURED. THE BALLOON WAS REMOVED WITHOUT ANY PROBLEMS USING THE NORMAL METHOD. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12885335 ↗
• InjuryOct 4, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6) CLINICAL TRIAL. IT WAS REPORTED THAT A DISSECTION OCCURRED. THE SUBJECT UNDERWENT TREATMENT WITH THREE RANGER DRUG COATED BALLOONS. THE FIRST TARGET LESION WAS IN THE LEFT PROXIMAL POPLITEAL ARTERY EXTENDING TO LEFT MID POPLITEAL ARTERY WITH PROXIMAL REFERENCE VESSEL DIAMETER OF 4.5 MM AND DISTAL REFERENCE VESSEL DIAMETER OF 4.0 MM WITH LESION LENGTH OF 150 MM AND 99% STENOSIS. TREATMENT OF TARGET LESION WAS PERFORMED BY DILATATION WITH STUDY DEVICE, RANGER DRUG COATED BALLOON 4 MM X 150 MM. DURING TREATMENT OF THE FIRST TARGET LESION, THE SUBJECT WAS NOTED WITH A COMPLICATION OF DISSECTION WITH SEVERITY GRADE OF E AND RESIDUAL STENOSIS OF 0%. A BAILOUT STENT WAS IMPLANTED, AND COMPLICATION WAS RESOLVED. THE PROCEDURE WAS CONTINUED. THE SECOND TARGET LESION WAS IN THE ENTIRE LENGTH OF LEFT SUPERFICIAL FEMORAL ARTERY EXTENDING TO LEFT PROXIMAL POPLITEAL ARTERY WITH PROXIMAL REFERENCE VESSEL DIAMETER OF 5.0 MM AND DISTAL REFERENCE VESSEL DIAMETER OF 5.5 MM WITH LESION LENGTH OF 200 MM AND 95% STENOSIS. TREATMENT OF TARGET LESION WAS PERFORMED BY DILATATION WITH STUDY DEVICE, RANGER DRUG COATED BALLOON 5 MM X 200 MM FOLLOWING POST TREATMENT, THE FINAL RESIDUAL STENOSIS WAS NOTE

  Patient problems: No Clinical Signs, Symptoms or Conditions; Vascular Dissection

  MAUDE report 12569632 ↗