Ranger™ H74939419402010Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 08714729975885), received between Sep 22, 2021 and Oct 21, 2025 — classified as 4 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (10 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• InjuryOct 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT RESTENOSIS AND PAIN OCCURRED. ON (B)(6) 2024, THE SUBJECT UNDERWENT TREATMENT WITH THE RANGER DRUG COATED BALLOONS AS A PART OF THE ELEGANCE CLINICAL TRIAL. THE TARGET LESION #001 WAS IN THE RIGHT PROXIMAL SUPERFICIAL FEMORAL ARTERY (SFA), RIGHT MID SUPERFICIAL FEMORAL ARTERY, RIGHT DISTAL SUPERFICIAL FEMORAL ARTERY EXTENDING UP TO RIGHT PROXIMAL POPLITEAL ARTERY WITH 6 MM PROXIMAL REFERENCE VESSEL DIAMETER AND 6 MM DISTAL REFERENCE VESSEL DIAMETER WITH LESION LENGTH OF 390 MM AND 100% STENOSIS AND WAS CLASSIFIED AS TASC II D LESION. TREATMENT OF TARGET LESION WAS PERFORMED BY DILATION USING STUDY DEVICES, 6 MM X 200 MM AND 4 MM X 200 MM RANGER DRUG COATED BALLOONS. FOLLOWING TREATMENT, 6 MM NON-BOSTON SCIENTIFIC (BSC) STENT WAS PLACED FROM RIGHT PROXIMAL SFA EXTENDING TO PROXIMAL POPLITEAL ARTERY FOLLOWED BY BALLOON TAILORING YIELDING COMPLETION AND THE FINAL RESIDUAL STENOSIS WAS NOTED TO BE 40%. ON THE SAME DAY, THE SUBJECT WAS DISCHARGED FROM HOSPITAL ON CLOPIDOGREL. ON (B)(6) 2025, SUBJECT VISITED THE EMERGENCY DEPARTMENT WITH THE COMPLAINTS OF WORSENED RIGHT LEG CLAUDICATION WITH SHORT WALKING DISTANCE AND OCCASIONAL REST PAIN. OF NOTE, ON OUTPATIENT DUPL

  Patient problems: Arteriosclerosis/ Atherosclerosis; Obstruction/Occlusion; Pain; Restenosis

  MAUDE report 23352448 ↗
• MalfunctionJun 12, 2025Material Deformation; Adverse Event Without Identified Device or Use Problem; Material Deformation; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 26MAY2025. IT WAS REPORTED THAT BALLOON KINKED OCCURRED. A 4.0 X 200MM, 150CM RANGER? DRUG-COATED BALLOON WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE PHYSICIAN USED TWO ACCESS SITES TO THE TARGET LOCATION. HOWEVER, DURING ADVANCING, IT WAS NOTED THAT THE BALLOON BECAME KINKED. THE PROCEDURE WAS THEN COMPLETED USING AN ALTERNATE METHOD. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. HOWEVER, DEVICE ANALYSIS REVEALED A PARTIAL BALLOON CIRCUMFERENTIAL TEAR LOCATED APPROXIMATELY 20MM DISTAL OF THE PROXIMAL MARKERBAND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22192677 ↗
• MalfunctionApr 23, 2025Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT DEVICE ENTRAPMENT OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 4.0 X 200MM, 150CM RANGER BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, IT WAS NOTED THAT THE BALLOON CATHETER BECAME STUCK WITH A NON-BOSTON SCIENTIFIC GUIDEWIRE, SO IT WAS NO LONGER POSSIBLE TO REACH THE LESION. THE BALLOON CATHETER AND GUIDEWIRE WERE REMOVED TOGETHER AS ONE UNIT. EVEN OUTSIDE THE PATIENT, THE GUIDEWIRE WAS NOT ABLE TO BE REMOVED FROM THE CATHETER. 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 21894281 ↗
• MalfunctionJun 4, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 4.0 X 200MM, 150CM RANGER PACLITAXEL-COATED PTA BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING FIRST INFLATION, THE BALLOON RUPTURED AT 6 ATMOSPHERES FOR 1 SECOND. THE DEVICE WAS REMOVED USING NORMAL METHOD WITHOUT ISSUE AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS IN GOOD CONDITION POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19459936 ↗
• MalfunctionMay 22, 2024Leak/Splash; Material Rupture; Leak/Splash; Material Rupture

  IT WAS REPORTED THAT A HOLE IN THE BALLOON WAS SUSPECTED. A 4.0 X 200MM, 150CM RANGER DRUG-COATED BALLOON WAS SELECTED FOR USE. DURING PREPARATION, THE PHYSICIAN TRIED TO PULL NEGATIVE TO REMOVE THE AIR FROM THE BALLOON, BUT IT WAS A CONSTANT STREAM OF AIR WHICH MAY SUGGEST THAT THERE WAS A HOLE IN THE BALLOON OR THE CATHETER SOMEWHERE. THE BALLOON WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER BALLOON. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19370724 ↗
• MalfunctionJan 8, 2024Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT THE CATHETER WAS STUCK ON THE GUIDEWIRE. A 4.0 X 200MM, 150CM RANGER DRUG-COATED BALLOON WAS SELECTED FOR USE. THE STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED POPLITEAL ARTERY. DURING THE PROCEDURE, WHEN THE PHYSICIAN TRIED TO ADVANCE THE RANGER OVER THE GUIDE WIRE, IT GOT STUCK INTO THE SHAFT. THE DEVICE WAS REMOVED FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18466495 ↗
• MalfunctionDec 6, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE BALLOON RUPTURED. A 4.0 X 200MM, 150CM RANGER PACLITAXEL-COATED PTA BALLOON CATHETER WAS SELECTED FOR AN ENDOVASCULAR THERAPY (EVT) PROCEDURE FOR LOWER-EXTREMITY ARTERIAL DISEASE OF THE SUPERFICIAL FEMORAL ARTERY. THE LESION WAS 75% STENOSED WITH MODERATELY TORTUOUS ANATOMY (SIMPLE CURVATURE) AND SEVERE CALCIFICATION. AFTER ONE INFLATION, THE BALLOON RUPTURED AT 5 ATM PRESSURE. THE BALLOON WAS REMOVED WITHOUT ANY PROBLEM. THERE WERE NO PATIENT COMPLICATIONS, AND THE CASE WAS COMPLETED WITH A DIFFERENT DEVICE OF THE SAME MODEL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18274044 ↗
• MalfunctionOct 2, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE BALLOON RUPTURED. THIS 4.0 X 200MM, 150CM RANGER PACLITAXEL-COATED PTA BALLOON CATHETER WAS SELECTED FOR USE IN A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE. THE 90% STENOSED, SEVERELY CALCIFIED, MODERATELY TORTUOUS TARGET LESION WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY. DURING THE PROCEDURE THE BALLOON RUPTURED AT THE DISTAL SIDE DURING THE FIRST INFLATION FOR TEN SECONDS AT 6ATM. A PINHOLE WAS NOTED. THE DEVICE WAS ABLE TO BE REMOVED INTACT. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE WITH NO PATIENT INJURY. THE DEVICE WAS DISCARDED AND THEREFORE NOT AVAILABLE FOR RETURN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17852410 ↗
• MalfunctionApr 28, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE BALLOON RUPTURED. A RANGER PACLITAXEL-COATED PTA BALLOON CATHETER 4.0 X 200 MM, 150 CM WAS SELECTED FOR THIS ENDOVASCULAR THERAPY PROCEDURE TO TREAT ARTERIOSCLEROSIS OBLITERANS OF THE SUPERFICIAL FEMORAL ARTERY. THE TARGET LESION HAD 100% STENOSIS WITH SEVERE CALCIFICATION AND MODERATE TORTUOSITY. THE PHYSICIAN INSERTED THE CATHETER, AND DURING TREATMENT THE BALLOON RUPTURED UPON A SINGLE INFLATION AT 8 ATM FOR SEVERAL SECONDS. THE BALLOON WAS REMOVED WITHOUT ANY PROBLEM, AND VISUAL OBSERVATION FOUND THE RUPTURE ON THE PROXIMAL SIDE OF THE SHOULDER PART OF THE BALLOON. THE PROCEDURE WAS ABLE TO BE COMPLETED SUCCESSFULLY USING ANOTHER RANGER WITHOUT SEQUELA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16831653 ↗
• MalfunctionMar 23, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE BALLOON RUPTURED. A RANGER PACLITAXEL-COATED PTA BALLOON CATHETER WAS SELECTED FOR USE IN THE POPLITEAL ARTERY FOR THE PERCUTANEOUS ANGIOPLASTY PROCEDURE. THE TARGET LESION WAS REPORTED TO BE 95% STENOSED WITH MODERATE TORTUOSITY AND SEVERE CALCIFICATION. THE RANGER WAS ADVANCED TO THE TARGET LESION AND INFLATED TO 14 ATM. AFTER 20 SECONDS, THE MIDDLE PORTION OF THE BALLOON EXPERIENCED A PINHOLE RUPTURE. THE RANGER WAS REMOVED FROM THE PATIENT WITHOUT ISSUE AND REPLACED WITH A NON-BSC PTA BALLOON. THE PROCEDURE WAS COMPLETED AND THERE WERE NO REPORTED CONSEQUENCES TO THE PATIENT. THE PATIENT CONDITION WAS GOOD FOLLOWING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16600943 ↗
• MalfunctionFeb 20, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE BALLOON RUPTURED. A RANGER PACLITAXEL-COATED PTA BALLOON CATHETER 4.0MM X 200MM, 150CM BALLOON CATHETER WAS SELECTED FOR ENDOVASCULAR THERAPY TO TREAT PERIPHERAL ARTERIAL DISEASE OF THE SUPERFICIAL FEMORAL ARTERY. THE PROCEDURE WAS BEING PERFORMED TO TREAT 100% STENOSIS, AND THE TARGET LESION CONTAINED MODERATE CALCIFICATION AND MODERATE TORTUOSITY. THE PHYSICIAN INSERTED THE CATHETER, AND UPON TREATMENT OF THE AREA THE BALLOON HAD A PINHOLE RUPTURE WITH A SINGLE INFLATION AT 12 ATM FOR ONE MINUTE. THE CATHETER WAS REMOVED AS INTENDED USING THE USUAL METHOD, AND THE RUPTURE WAS ABLE TO BE OBSERVED NEAR THE CENTER OF THE BALLOON. THE PROCEDURE WAS ABLE TO BE COMPLETED SUCCESSFULLY USING ANOTHER RANGER AND JADE DEVICE WITHOUT SEQUELA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16406034 ↗
• InjuryDec 21, 2022Failure to Deflate; Failure to Deflate

  IT WAS REPORTED THAT THE BALLOON FAILED TO DEFLATE. A 4X200MM, 150CM RANGER DRUG-COATED BALLOON WAS SELECTED FOR USE IN AN ATHERECTOMY AND ANGIOPLASTY PROCEDURE IN THE SUPERFICIAL FEMORAL ARTERY (SFA). AFTER ATHERECTOMY, ANGIOPLASTY WAS PERFORMED WITH THE RANGER DEVICE. THE BALLOON WAS INFLATED TO 8 ATMOSPHERES FOR TWO MINUTES. WHEN IT WAS TIME TO DEFLATE, THE BALLOON WOULD NOT DEFLATE. OVER THE COURSE OF 15 MINUTES, MULTIPLE ATTEMPTS WERE MADE TO PULL SUCTION WITH ADDITIONAL SYRINGES AND NEW INFLATION DEVICES. AFTER MANY FAILED ATTEMPTS, AN ATTEMPT WAS MADE TO PUNCTURE THE BALLOON WITH ANOTHER WIRE, BUT IT WAS UNSUCCESSFUL. INSTEAD, THE PARTIALLY INFLATED BALLOON AND SHEATH WERE PULLED OUT OF THE PATIENT WITH THE WIRE REMAINING IN PLACE. A NEW SHEATH WAS INSERTED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER 4X200MM, 150CM RANGER DRUG-COATED BALLOON. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16029920 ↗
• InjuryDec 12, 2022Difficult to Remove; Material Rupture; Detachment of Device or Device Component; Difficult to Remove; Material Rupture; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE BALLOON BURST AND DETACHED REQUIRING ADDITIONAL INTERVENTION. THE STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED RIGHT SUPERFICIAL FEMORAL (SFA) ARTERY. A 4.0 X 200MM, 150CM RANGER PACLITAXEL-COATED PTA BALLOON CATHETER WAS SELECTED FOR USE. DURING THE FIRST INFLATION TO 8 ATM FOR APPROXIMATELY 2.5 MINUTES, THE BALLOON BURST. THE BALLOON WAS ATTEMPTED TO BE DEFLATED FOR 2 MINUTES; HOWEVER, IT WAS DIFFICULT TO RETRACT THE BALLOON THROUGH THE SHEATH. THE MAJORITY OF THE BALLOON WAS PULLED FROM THE PATIENT OVER THE GUIDEWIRE. A SNARE WAS USED TO REMOVE THE REMAINING RESIDUAL OF THE DEVICE FROM THE PATIENT, ADDING 30 MINUTES TO THE PROCEDURE TIME. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15960780 ↗
• MalfunctionNov 15, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED SUPERFICIAL FEMORAL ARTERY (SFA). A 4.0 X 200MM, 150CM RANGER PACLITAXEL-COATED PTA BALLOON CATHETER WAS SELECTED FOR THE ENDOVASCULAR THERAPY PROCEDURE. HOWEVER, THE BALLOON RUPTURED AT 5 ATMOSPHERES DURING THE FIRST INFLATION AFTER 5 SECONDS DURATION. THE DEVICE WAS ABLE TO BE REMOVED USING THE NORMAL METHOD. THE PROCEDURE WAS COMPLETED USING ANOTHER BALLOON, AND THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15797617 ↗
• MalfunctionSep 19, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. (B)(4). AFTER DECOMPRESSION, THE DEVICE WAS REMOVED FROM THE BODY AND THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE OF A DIFFERENT MODEL. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT WAS IN GOOD CONDITION FOLLOWING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15445279 ↗
• InjuryJul 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ELEGANCE STUDY. IT WAS REPORTED THAT A DISSECTION OCCURRED. THE SUBJECT UNDERWENT TREATMENT WITH THE TWO RANGER DRUG-COATED BALLOONS ON (B)(6) 2021 AS A PART OF THE ELEGANCE CLINICAL TRIAL. THE TARGET LESION WAS IN LEFT DISTAL SUPERFICIAL FEMORAL ARTERY (SFA) EXTENDING TO LEFT PROXIMAL POPLITEAL ARTERY WITH PROXIMAL REFERENCE VESSEL DIAMETER OF 5 MM AND DISTAL REFERENCE VESSEL DIAMETER OF 4 MM. THE LESION LENGTH OF 250 MM WITH 100% STENOSIS AND WAS CLASSIFIED AS TASC II D LESION. PRIOR TO TARGET LESION TREATMENT, PRE-DILATATION WAS PERFORMED WITH A NON-BSC PTA BALLOON 3 MM X 200 MM, THEN TREATMENT WAS PERFORMED USING RANGER DRUG COATED BALLOONS OF 4.0 MM X 200 MM AND 5.0 MM X 60 MM. POST-TARGET LESION TREATMENT, BALLOON DILATION WAS PERFORMED WITH A NON-BSC PTA BALLOON OF 4 MM X 120 MM AND 5 MM X 120 MM. FOLLOWING THE TREATMENT, THE FINAL RESIDUAL STENOSIS WAS NOTED TO BE 0%. ON (B)(6) 2021, DURING THE INDEX PROCEDURE, A DISSECTION OF GRADE B IN THE TARGET LESION WAS NOTED DUE TO STUDY DEVICES AND A NON-BSC BARE METAL STENT WAS DEPLOYED IN RESPONSE. ON THE SAME DAY, SUBJECT WAS DISCHARGED FROM THE HOSPITAL ON CLOPIDOGREL AND ASPIRIN.

  Patient problems: Vascular Dissection

  MAUDE report 15067984 ↗
• MalfunctionSep 22, 2021Deflation Problem; Inflation Problem; Deflation Problem; Inflation Problem

  IT WAS REPORTED THAT A SLOW BALLOON DEFLATION OCCURRED. A RANGER 4.0MM X 200MM WAS SELECTED FOR USE DURING AN ENDOVASCULAR TREATMENT FOR PERIPHERAL ARTERY DISEASE. THE LESION WAS 90% STENOSED, MILDLY CALCIFIED AND MODERATELY TORTUOUS IN THE SUPERFICIAL FEMORAL ARTERY. THE BALLOON WAS INFLATED ONE TIME FOR 180 SECONDS AT 6 ATMOSPHERES OF PRESSURE. THE BALLOON WAS NOTED TO BE SLOW TO DEFLATE, WHICH WAS APPROXIMATELY 60-90 SECONDS IN DURATION. LOW PRESSURE WAS MAINTAINED. THE PROCEDURE WAS STILL ABLE TO BE COMPLETED WITH THIS DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12516570 ↗