Ranger™ H74939419401590Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08714729975878), received between Aug 30, 2021 and May 16, 2024 — classified as 4 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 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 16, 2024Material 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 4.0 X 150MM, 90CM RANGER (DCB) WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON RUPTURED UPON FIRST INFLATION AT 8 ATMOSPHERES FOR FEW SECONDS. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS IN GOOD CONDITION AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19332624 ↗
• MalfunctionNov 21, 2023Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT GUIDEWIRE ENTRAPMENT OCCURRED. A 4.0 X 150MM, 90CM RANGER GLOBAL DCB OTW BALLOON WAS SELECTED FOR AN ENDOVASCULAR THERAPY (EVT) PROCEDURE IN 90% STENOSED MODERATELY TORTUOUS ANATOMY WITH MILD CALCIFICATION. A NON-BOSTON SCIENTIFIC (BSC) GUIDEWIRE WAS USED IN THE PROCEDURE. PER PHYSICIAN COMMENT, THE PATIENT HAD BECOME AGGRESSIVE WHILE INSERTING THE DEVICE CAUSING THE SHAFT TO KINK AND THE WIRE TO BECOME ENTRAPPED IN THE DEVICE. BOTH DEVICE AND GUIDEWIRE HAD TO BE REMOVED TOGETHER. 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 18181205 ↗
• MalfunctionMar 16, 2023Material 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 150MM, 90CM RANGER PACLITAXEL-COATED PTA BALLOON CATHETER WAS SELECTED FOR USE. UPON THE FIRST INFLATION AT 6 ATMOSPHERES FOR 10 SECONDS, A PINHOLE OCCURRED IN THE DISTAL SIDE OF THE BALLOON. THE DEVICE WAS REMOVED FROM THE PATIENT USING THE NORMAL METHOD WITHOUT ANY ISSUES. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT STATUS WAS GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16552620 ↗
• MalfunctionAug 30, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. A RANGER DRUG-ELUTING PERIPHERAL TRANSLUMINAL ANGIOPLASTY CATHETER WAS SELECTED FOR USE DURING IN THE LEFT SUPERFICIAL FEMORAL ARTERY. THE 95% STENOSED TARGET LESION WAS REPORTED TO BE MODERATELY TORTUOUS AND MODERATELY CALCIFIED. THE BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING THE FIRST INFLATION AT 10 ATMOSPHERES FOR 20 SECONDS, THE BALLOON RUPTURED. THE SHAPE WAS NOTED TO BE A PINHOLE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE AND NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12387706 ↗