RangerRecalls & reported problems across all models

We found 50 models of Ranger by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 508 adverse event reports in the FDA's MAUDE database, received between Apr 16, 2021 and Sep 30, 2026 — classified as 1 death, 215 injuries, 292 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (218 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Ranger problems

Ranger models

50 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Ranger™ H74939419502010

  Drug-Eluting Peripheral Transluminal Angioplasty Catheter
  71 reports
• Ranger™ H74939419602010

  Drug-Eluting Peripheral Transluminal Angioplasty Catheter
  71 reports
• Ranger™ H74939419600610

  Drug-Eluting Peripheral Transluminal Angioplasty Catheter
  36 reports
• Ranger™ H74939419501510

  Drug-Eluting Peripheral Transluminal Angioplasty Catheter
  34 reports
• Ranger™ H74939419601510

  Drug-Eluting Peripheral Transluminal Angioplasty Catheter
  27 reports
• Ranger™ H74939419601010

  Drug-Eluting Peripheral Transluminal Angioplasty Catheter
  26 reports
• Ranger™ H74939419500610

  Drug-Eluting Peripheral Transluminal Angioplasty Catheter
  18 reports
• Ranger™ H74939419402010

  Drug-Eluting Peripheral Transluminal Angioplasty Catheter
  17 reports
• Ranger™ H74939419401510

  Drug-Eluting Peripheral Transluminal Angioplasty Catheter
  14 reports
• Ranger™ H74939419501010

  Drug-Eluting Peripheral Transluminal Angioplasty Catheter
  12 reports
• Ranger™ H74939419701010

  Drug-Eluting Peripheral Transluminal Angioplasty Catheter
  9 reports
• Ranger™ H74939419400410

  Drug-Eluting Peripheral Transluminal Angioplasty Catheter
  8 reports
• Ranger™ H74939419501590

  Drug-Eluting Peripheral Transluminal Angioplasty Catheter
  8 reports
• Ranger™ H74939419600680

  Drug-Eluting Peripheral Transluminal Angioplasty Catheter
  8 reports
• Ranger™ H74939419602090

  Drug-Eluting Peripheral Transluminal Angioplasty Catheter
  8 reports
• Ranger™ H74939419700410

  Drug-Eluting Peripheral Transluminal Angioplasty Catheter
  8 reports
• Ranger™ H74939733606020

  Drug-Eluting Peripheral Transluminal Angioplasty Catheter
  7 reports
• Ranger™ H74939419400810

  Drug-Eluting Peripheral Transluminal Angioplasty Catheter
  1 death7 reports
• Ranger™ H74939419401010

  Drug-Eluting Peripheral Transluminal Angioplasty Catheter
  7 reports
• Ranger™ H74939419401080

  Drug-Eluting Peripheral Transluminal Angioplasty Catheter
  7 reports
• Ranger™ H74939419502090

  Drug-Eluting Peripheral Transluminal Angioplasty Catheter
  7 reports
• Ranger™ H74939419600410

  Drug-Eluting Peripheral Transluminal Angioplasty Catheter
  7 reports
• Ranger™ H74939733620020

  Drug-Eluting Peripheral Transluminal Angioplasty Catheter
  6 reports
• Ranger™ H74939419400680

  Drug-Eluting Peripheral Transluminal Angioplasty Catheter
  6 reports
• Ranger™ H74939419500810

  Drug-Eluting Peripheral Transluminal Angioplasty Catheter
  6 reports
• Ranger™ H74939419501210

  Drug-Eluting Peripheral Transluminal Angioplasty Catheter
  6 reports
• Ranger™ H74939419700610

  Drug-Eluting Peripheral Transluminal Angioplasty Catheter
  6 reports
• Ranger™ H74939419500680

  Drug-Eluting Peripheral Transluminal Angioplasty Catheter
  5 reports
• Ranger™ H74939419601080

  Drug-Eluting Peripheral Transluminal Angioplasty Catheter
  5 reports
• Ranger™ H74939419601590

  Drug-Eluting Peripheral Transluminal Angioplasty Catheter
  5 reports
• Ranger™ H74939419401590

  Drug-Eluting Peripheral Transluminal Angioplasty Catheter
  4 reports
• Ranger™ H74939419500410

  Drug-Eluting Peripheral Transluminal Angioplasty Catheter
  4 reports
• Ranger™ H74939419501080

  Drug-Eluting Peripheral Transluminal Angioplasty Catheter
  4 reports
• Ranger™ H74939419600810

  Drug-Eluting Peripheral Transluminal Angioplasty Catheter
  4 reports
• Ranger™ H74939733506020

  Drug-Eluting Peripheral Transluminal Angioplasty Catheter
  3 reports
• Ranger™ H74939733515020

  Drug-Eluting Peripheral Transluminal Angioplasty Catheter
  3 reports
• Ranger™ H74939419400610

  Drug-Eluting Peripheral Transluminal Angioplasty Catheter
  3 reports
• Ranger™ H74939733406020

  Drug-Eluting Peripheral Transluminal Angioplasty Catheter
  2 reports
• Ranger™ H74939733420020

  Drug-Eluting Peripheral Transluminal Angioplasty Catheter
  2 reports
• Ranger™ H74939733610020

  Drug-Eluting Peripheral Transluminal Angioplasty Catheter
  2 reports
• Ranger™ H74939733615020

  Drug-Eluting Peripheral Transluminal Angioplasty Catheter
  2 reports
• Ranger™ H74939419402090

  Drug-Eluting Peripheral Transluminal Angioplasty Catheter
  2 reports
• Ranger™ H74939419601210

  Drug-Eluting Peripheral Transluminal Angioplasty Catheter
  2 reports
• Ranger™ H74939419700680

  Drug-Eluting Peripheral Transluminal Angioplasty Catheter
  2 reports
• Ranger™ H74939419701510

  Drug-Eluting Peripheral Transluminal Angioplasty Catheter
  2 reports
• Ranger™ H74939733510020

  Drug-Eluting Peripheral Transluminal Angioplasty Catheter
  1 report
• Ranger™ H74939733520020

  Drug-Eluting Peripheral Transluminal Angioplasty Catheter
  1 report
• Ranger™ H74939733706020

  Drug-Eluting Peripheral Transluminal Angioplasty Catheter
  1 report
• Ranger™ H74939733710020

  Drug-Eluting Peripheral Transluminal Angioplasty Catheter
  1 report
• Ranger™ H74939419702010

  Drug-Eluting Peripheral Transluminal Angioplasty Catheter
  1 report

Recent Ranger adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Vascular Dissection

  MAUDE report 50948177 ↗
• InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Vascular Dissection

  MAUDE report 50940541 ↗
• MalfunctionSep 21, 2026Material Rupture

  It was reported that balloon rupture occurred. The 90% stenosed target lesion was located in the moderately tortuous superficial femoral artery (SFA). A 6.0 x 100 mm 200 cm Ranger Drug-Coated Balloon catheter was advanced for dilation. During the procedure, the balloon ruptured upon first inflation at nominal atmospheres. The device was removed without any problem using the normal method, and the procedure was completed with another of the same device. There were no patient complications as a result of this event, and the patient's condition was satisfactory after the procedure.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50839500 ↗
• InjurySep 18, 2026Break; Nonstandard Device; Difficult to Remove; Material Rupture; Failure to Deflate

  It was reported that balloon rupture, catheter separation, and removal difficulty occurred requiring additional intervention.The 100% stenosed target lesion was located in the severely calcified superficial femoral artery. The lesion was successfully crossed and pre-dilated using a Sterling balloon (size unknown). An Eluvia stent was then deployed in the lesion. Subsequently, a 5.0 x 80mm, 135cm Ranger Drug Coated balloon was used to treat a more distal popliteal lesion. During a subsequent inflation within the newly placed Eluvia stent, the Ranger balloon ruptured on the second inflation. The entire catheter shaft was also broken. Following the rupture, the physician experienced significant difficulty retracting the damaged device through the stent, lesion, and sheath. Because the balloon had ruptured, vacuum could not be maintained, and complete deflation could not be confirmed. A snare was required to retrieve the damaged balloon catheter from the patient. The device was removed successfully, and no fragments were reported to have remained in the patient. Upon removal, severe physical damage was noted and was described as being in a "curly-q" configuration. The procedure was com

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50820244 ↗
• InjurySep 15, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that gangrene of the right 5th toe occurred with occlusion of the right SFA treatment site, requiring additional intervention.The subject underwent treatment with the Ranger drug-coated balloon on (b)(6) 2026 as a part of the clinical trial. The target lesion #001 was in the right proximal superficial femoral artery (SFA) with 6 mm proximal reference vessel diameter and 6 mm distal reference vessel diameter with 10 mm lesion length and 80 % stenosis and classified as TransAtlantic InterSociety Consensus (TASC) II B lesion. Prior to the treatment of target lesion with the study device, atherectomy was performed with 1.5 mm x 145 mm diamondback atherectomy device and pre-dilation was performed using 5 mm x 220 mm Sterling balloon. Treatment of target lesion was performed by dilation using 6 mm x 200 mm Ranger drug coated balloon, study device. The balloon was inflated once to a maximum inflation pressure of 8 atmospheres for 3 seconds. Following treatment, the final residual stenosis was noted to be 35%. The target lesion #002 was in the right distal superficial femoral artery with 6 mm proximal reference vessel diameter and 6 mm distal reference vessel diameter with

  Patient problems: Necrosis; Obstruction/Occlusion

  MAUDE report 50779600 ↗
• InjurySep 15, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that gangrene of the right 5th toe occurred with occlusion of the right SFA treatment site, requiring additional intervention.The subject underwent treatment with the Ranger drug-coated balloon on (b)(6) 2026 as a part of the clinical trial. The target lesion #001 was in the right proximal superficial femoral artery (SFA) with 6 mm proximal reference vessel diameter and 6 mm distal reference vessel diameter with 10 mm lesion length and 80 % stenosis and classified as TransAtlantic InterSociety Consensus (TASC) II B lesion. Prior to the treatment of target lesion with the study device, atherectomy was performed with 1.5 mm x 145 mm diamondback atherectomy device and pre-dilation was performed using 5 mm x 220 mm Sterling balloon. Treatment of target lesion was performed by dilation using 6 mm x 200 mm Ranger drug coated balloon, study device. The balloon was inflated once to a maximum inflation pressure of 8 atmospheres for 3 seconds. Following treatment, the final residual stenosis was noted to be 35%. The target lesion #002 was in the right distal superficial femoral artery with 6 mm proximal reference vessel diameter and 6 mm distal reference vessel diameter with

  Patient problems: Necrosis; Obstruction/Occlusion

  MAUDE report 50779598 ↗
• InjurySep 14, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Vascular Dissection

  MAUDE report 50762321 ↗
• InjurySep 3, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that restenosis occurred requiring additional intervention.The target lesion was located in the right arm AV fistula outflow vein (basilic vein). On Mar. 31, 2026, two Ranger Paclitaxel-Coated PTA Balloon Catheters were selected for use in a clinical study: a 6.0 x 40 mm, 135 cm Ranger balloon, which was inflated once at 9 atmospheres for 150 seconds, and a 5.0 x 40 mm, 135 cm Ranger balloon, which was inflated once at 8 atmospheres for 150 seconds. On (b)(6), 2026, restenosis of the right AV fistula outflow vein occurred, and the patient underwent an angioplasty procedure. On (b)(6), 2026, the event was considered resolved.

  Patient problems: Restenosis

  MAUDE report 50587895 ↗
• InjuryAug 20, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that target lesion revascularization occurred requiring additional intervention.The target lesions were located in the left common femoral artery, proximal superficial femoral artery, distal superficial femoral artery, and proximal popliteal artery. On (b)(6) 2025, a 6 x 150 mm, 150 cm Ranger Drug-Coated Balloon was used to treat target lesion #001, and a 5 x 150 mm, 150 cm Ranger Drug-Coated Balloon was used to treat target lesion #002. Both balloons were inflated once at 10 atmospheres for 180 seconds. On (b)(4) 2026, the patient underwent an interventional revascularization procedure consisting of Shockwave therapy, Rotarex atherectomy, and drug-coated balloon angioplasty and the event was considered resolved on (b)(6) 2026.

  Patient problems: Restenosis

  MAUDE report 50351076 ↗
• MalfunctionAug 17, 2026Material Rupture

  It was reported that balloon rupture occurred.The 100% stenosed target lesion was located in the mildly tortuous and severely calcified superficial femoral artery. A 5.0 x 150mm, 150cm Ranger balloon catheter was advanced for dilation. During the first inflation at 6 atmospheres for 20 seconds, the balloon ruptured. The device was removed using normal method without issue and the procedure was completed with another of the same device. There were no patient complications as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50278478 ↗
• InjuryAug 14, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient experienced pain in the left lower extremity.On (b)(6)2022, the patient underwent treatment of a target lesion in the mid-to-distal superficial femoral artery using a 4.0 x 100 mm, 135 cm Ranger Drug-Coated Balloon. The balloon was inflated to 8 atmospheres for 180 seconds. On (b)(6)2024, the patient experienced pain in the left lower extremity involving calf and radiating to foot. Additional intervention was performed using drug-coated balloon (DCB) angioplasty and balloon angioplasty. The event subsequently resolved on (b)(6)2025.

  Patient problems: Pain

  MAUDE report 50255881 ↗
• MalfunctionJul 22, 2026Entrapment of Device; Material Twisted/Bent; Adverse Event Without Identified Device or Use Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25905900 ↗
• InjuryJul 14, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT VESSEL OCCLUSION OCCURRED REQUIRING INTERVENTION. ON (B)(6) 2021, AS PART OF THE CLINICAL TRIAL, THE SUBJECT UNDERWENT TREATMENT WITH THE RANGER DRUG COATED BALLOON AND ELUVIA DRUG ELUTING STENTS. THE TARGET LESION #001 WAS IN THE LEFT PROXIMAL SUPERFICIAL FEMORAL ARTERY, MID SUPERFICIAL FEMORAL ARTERY, DISTAL SUPERFICIAL FEMORAL ARTERY AND PROXIMAL POPLITEAL ARTERY WITH 5 MM PROXIMAL REFERENCE VESSEL DIAMETER AND 4.5 MM DISTAL REFERENCE VESSEL DIAMETER WITH 360 MM LESION LENGTH AND 100% STENOSIS AND WAS CLASSIFIED AS TRANSATLANTIC INTER-SOCIETY CONSENSUS (TASC) II D LESION. PRIOR TO THE TREATMENT OF TARGET LESION WITH THE STUDY DEVICE, LITHOTRIPSY WAS PERFORMED USING 5 MM X 60 MM SHOCKWAVE DEVICE, PRE-DILATION WAS PERFORMED USING 4 MM X 220 MM, 3 MM X 220 MM COYOTE OTW PTA BALLOONS AND 3.5 MM X 120 MM SERRANATOR CUTTING BALLOON. THE TREATMENT OF STENOSIS IN THE LEFT PROXIMAL SUPERFICIAL FEMORAL ARTERY, MID SUPERFICIAL FEMORAL ARTERY, DISTAL SUPERFICIAL FEMORAL ARTERY AND PROXIMAL POPLITEAL ARTERY WAS PERFORMED BY DILATION USING 5 MM X 150 MM RANGER DRUG-COATED BALLOON, STUDY DEVICE. FOLLOWING WHICH 6 MM X 120 MM, 6 MM X 100 MM ELUVIA DRUG-ELUTING STENTS, STUDY

  Patient problems: Vascular Dissection

  MAUDE report 25818464 ↗
• InjuryJul 6, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT TARGET LESION REVASCULARIZATION (TLR) OCCURRED REQUIRING ADDITIONAL INTERVENTION. THE TARGET LESION WAS LOCATED IN THE MID SUPERFICIAL FEMORAL ARTERY OF THE RIGHT LEG. ON (B)(6) 2025, A 6.0 X 150 MM, 150 CM RANGER DRUG-COATED BALLOON WAS SELECTED FOR USE IN A CLINICAL STUDY. THE BALLOON WAS INFLATED ONCE AT 14 ATMOSPHERES FOR 180 SECONDS. ON (B)(6) 2026, THE PATIENT UNDERWENT TARGET LESION REVASCULARIZATION USING A DRUG-COATED BALLOON. THEN IT RESULTED IN A NEW HOSPITALIZATION ON THE SAME DAY. ON JUN. 2, 2026, THE EVENT WAS CONSIDERED RESOLVED.

  Patient problems: Restenosis

  MAUDE report 25725387 ↗
• MalfunctionMay 13, 2026Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED RIGHT SUPERFICIAL FEMORAL ARTERY (SFA). A 5.0 X 150 MM 200CM RANGER DCB BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON RUPTURED UPON FIRST INFLATION AT 6 ATMOSPHERES FOR 20 SECONDS. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25160552 ↗

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