Ranger™ H74939419400680Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 08714729975793), received between Apr 23, 2021 and Mar 26, 2025 — classified as 1 injury, 5 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 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.

• MalfunctionMar 26, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED DISTAL LEFT SUPERFICIAL FEMORAL ARTERY. AFTER PERFORMING AN IPSILATERAL PUNCTURE, A GUIDEWIRE WAS PASSED THROUGH THE LESION FOLLOWED BY ADVANCING A 4.0 X 60MM, 80CM RANGER BALLOON CATHETER FOR DILATATION. HOWEVER, DURING THE FIRST INFLATION AT 6 ATMOSPHERES FOR 10 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH A 135CM-SHAFT RANGER BALLOON CATHETER. THE LESION WAS TREATED SUCCESSFULLY. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21699609 ↗
• MalfunctionMar 18, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 4.0 X 60MM, 80CM RANGER DRUG-COATED BALLOON WAS ADVANCED FOR DILATION. HOWEVER, DURING THE FIRST INFLATION AT 14 ATMOSPHERES FOR 2 MINUTES, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED 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 18926775 ↗
• MalfunctionJul 31, 2023Leak/Splash; Material Rupture; Leak/Splash; Material Rupture

  IT WAS REPORTED THAT THE BALLOON RUPTURED AND HAD A PINHOLE. THIS 4.0 X 60MM, 80CM RANGER PACLITAXEL-COATED PTA BALLOON CATHETER WAS SELECTED FOR USE IN AN ENDOVASCULAR THERAPY PROCEDURE. THE 99% STENOSED, MODERATELY CALCIFIED, AND MODERATELY TORTUOUS LESION WAS LOCATED IN THE RIGHT SUPERFICIAL FEMORAL ARTERY. THE BALLOON RUPTURED AND EXHIBITED A PINHOLE SLIGHTLY DISTAL FROM THE BALLOON CATHETER CENTER. THIS WAS NOTED DURING THE FIRST INFLATION AT 8 ATM FOR APPROXIMATELY FIVE SECONDS. THE BALLOON WAS REMOVED INTACT, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THE PHYSICIAN NOTED THIS WAS EFFECTS OF CALCIFICATION. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17424155 ↗
• MalfunctionMay 11, 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 4.0 X 60MM, 80CM RANGER PACLITAXEL-COATED PTA BALLOON CATHETER WAS SELECTED FOR THE ENDOVASCULAR THERAPY PROCEDURE. THE RANGER PACLITAXEL-COATED PTA BALLOON CATHETER WAS ADVANCED FOR DILATION; HOWEVER, DURING THE FIRST INFLATION AT 6 ATMOSPHERES FOR 30 SECONDS INFLATION TIME, THE BALLOON RUPTURED. AFTER DECOMPRESSION, THE DEVICE WAS REMOVED FROM THE BODY AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14360723 ↗
• MalfunctionApr 29, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE BALLOON RUPTURED. THE 95% STENOSED TARGET LESION WAS MODERATELY CALCIFIED, MILDLY TORTUOUS AND LOCATED IN THE SUPERFICIAL FEMORAL ARTERY (SFA). A RANGER DRUG-COATED BALLOON WAS SELECTED FOR USE. DURING THE FIRST INFLATION, THE BALLOON WAS INFLATED TO 6ATM FOR 10 TEN SECONDS. HOWEVER, THE BALLOON THEN RUPTURED. THE PROCEDURE WAS COMPLETED USING THIS DEVICE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14256008 ↗
• InjuryApr 23, 2021Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT SLOW FLOW OCCURRED. THE LESION LOCATED IN THE SUPERFICIAL FEMORAL ARTERY (SFA) WAS DILATED THREE TIMES WITH A 3.5 MM X 4 CM COYOTE BALLOON. THE LESION WAS THEN DILATED FOR THREE MINUTES WITH THE 4MM X 60MM X 80CM RANGER DRUG COATED BALLOON. AFTERWARDS, WHEN CONTRAST WAS PERFORMED, A SLOW FLOW OF BLOOD WAS OBSERVED. THE PROCEDURE WAS COMPLETED WITH IMPROVED SLOW FLOW BY USING A VASODILATOR. IT WAS THOUGHT THAT THE PACLITAXEL APPLIED TO THE RANGER MAY HAVE COME OFF TO THE PERIPHERY.

  Patient problems: Obstruction/Occlusion

  MAUDE report 11715800 ↗