Ranger™ H74939733620020Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00191506046811), received between Aug 28, 2025 and Jul 22, 2026 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (4 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• InjuryMar 9, 2026Difficult to Advance

  IT WAS REPORTED THAT PARTIAL DISSECTION OCCURRED REQUIRING ADDITIONAL INTERVENTION. A 6.0 X 200 MM 200CM RANGER DRUG-COATED BALLOON CATHETER WAS SELECTED FOR USE. DURING THE PROCEDURE, THE SHEATH HAD BEEN INSERTED AT A SLIGHTLY RIGHT ANGLE. ALTHOUGH THE BALLOON CROSSED WITHOUT DIFFICULTY, THE RANGER COULD NOT PASS THROUGH THE SHEATH AND WAS SLOWLY WITHDRAWN TOGETHER WITH THE SHEATH (WITH THE SHEATH LEFT IN PLACE). THE SECOND 6.0 X 200 MM 200CM RANGER DRUG-COATED BALLOON CATHETER WAS ALSO QUITE TIGHT BUT WAS EVENTUALLY DELIVERED. CONSEQUENTLY, A PARTIAL DISSECTION WAS NOTED AFTER THE REMOVAL OF THE 2ND RANGER DRUG-COATED BALLOON CATHETER. AS A RESULT, A NON-BOSTON SCIENTIFIC STENT WAS PLACED AS A BAILOUT. AFTER THE PROCEDURE, THE SHEATH WAS CHECKED AND NO KINKING OR OTHER ABNORMALITIES WERE OBSERVED. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: Vascular Dissection

  MAUDE report 24552616 ↗
• MalfunctionNov 27, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 6.0 X 200 MM 200CM RANGER DCB MR WAS SELECTED ADVANCED FOR DILATION. DURING THE FIRST INFLATION AT 12 ATMOSPHERES FOR 30 SECONDS, THE BALLOON RUPTURED. IT IS PRESUMED THAT THE CAUSE WAS NOT THE ANATOMICAL STRUCTURE, BUT RATHER THE CALCIFICATION OF THE LESION. THE DEVICE WAS REMOVED USING NORMAL METHOD WITHOUT ISSUE AND THE PROCEDURE WAS COMPLETED WITH DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23667736 ↗
• MalfunctionNov 23, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 6.0 X 200 MM 200CM RANGER BALLOON CATHETER WAS ADVANCED FOR DILATATION. DURING THE PROCEDURE, THE BALLOON RUPTURED AFTER THE FIRST INFLATION AT 14 ATMOSPHERES FOR 15 SECONDS. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM, AND THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23627621 ↗
• MalfunctionSep 9, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE STENOSED TARGET LESION WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY. A 6.0 X 200 MM 200CM RANGER DRUG COATING BALLOON WAS SELECTED FOR USE. DURING THE PROCEDURE, THE BALLOON RUPTURED UPON FIRST INFLATION AT 8 ATMOSPHERES FOR 180 SECONDS. THE DEVICE WAS REMOVED USING NORMAL METHOD WITHOUT ISSUE 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 23006125 ↗
• MalfunctionAug 28, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS AN AREA OF IN-STENT RESTENOSIS (ISR) LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 6.0 X 200 MM 200CM RANGER (DCB) BALLOON CATHETER WAS SELECTED FOR USE. DURING THE PROCEDURE, THE BALLOON RUPTURED AT 14 ATMOSPHERES. 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 22915505 ↗