Ranger™ H74939419601590Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08714729976196), received between Sep 1, 2021 and May 7, 2025 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 7, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 6.0 X 150MM, 90CM RANGER? BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON RUPTURED UPON FIRST INFLATION AT 6 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 21979099 ↗
• MalfunctionApr 23, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT DEVICE CONTAMINATION OCCURRED. THE 75% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS SUPERFICIAL FEMORAL ARTERY. A 6.0 X 150MM, 90CM RANGER DRUG-COATED BALLOON WAS SELECTED FOR USE. HOWEVER, TWO THREAD-LIKE FOREIGN OBJECTS WERE NOTED ON THE DEVICE. THEY WERE PULLED BY FINGER, PEELED OFF FROM THE RANGER BALLOON, AND THE PROCEDURE WAS COMPLETED USING THIS DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21893680 ↗
• MalfunctionMar 6, 2024Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT CATHETER ENTRAPMENT OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED LEFT SUPERFICIAL FEMORAL ARTERY. A 6.0 X 150MM, 90CM RANGER PACLITAXEL-COATED PTA BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, IT WAS NOTED THAT THE BALLOON BECAME STUCK WITH A 014 NON-BOSTON SCIENTIFIC GUIDEWIRE. BOTH DEVICES WERE REMOVED AS A SINGLE UNIT. THE PROCEDURE WAS COMPLETED USING THIS DEVICE. NO COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18848441 ↗
• MalfunctionOct 19, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE BALLOON RUPTURED. A 6.0 X 150MM, 90CM RANGER DRUG-COATED BALLOON WAS SELECTED FOR USE IN A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE IN THE LEFT SUPERFICIAL FEMORAL ARTERY (SFA). THE TARGET LESION WAS 99% STENOSED WITH MODERATE CALCIFICATION AND TORTUOSITY. THE BALLOON WAS INFLATED AT 8 ATM FOR 20 SECONDS DURING THE FIRST INFLATION AT WHICH POINT IT RUPTURED. THE BALLOON WAS REMOVED. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12662208 ↗
• MalfunctionSep 1, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE BALLOON RUPTURED. A 6.0 X 150MM, 90CM RANGER PACLITAXEL-COATED PTA BALLOON CATHETER WAS SELECTED FOR A PATIENT PROCEDURE IN THE RIGHT SUPERFICIAL FEMORAL ARTERY. THE PATIENT HAD PERIPHERAL ARTERY DISEASE. THE LESION WAS SEVERELY TORTUOUS, 99% STENOSED, AND MODERATELY CALCIFIED. DURING THE PROCEDURE, INSIDE OF THE PATIENT, THE BALLOON RUPTURED AT 10ATM DURING THE FIRST INFLATION. THE SHAPE OF THE RUPTURE WAS A PINHOLE. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEMS. THE PATIENT WAS IN GOOD CONDITION AFTER THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12408917 ↗