Ranger™ H74939419400610Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08714729975786), received between Nov 11, 2021 and Nov 17, 2023 — classified as 3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 17, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT DEVICE MATERIAL RUPTURE OCCURRED. A 4.0 X 60MM, 135CM RANGER GLOBAL DCB OTW BALLOON WAS SELECTED FOR A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE IN THE LEFT SUPERFICIAL FEMORAL ARTERY (SFA) WITH 99% STENOSED MODERATELY TORTUOUS ANATOMY WITH SEVERE CALCIFICATION. EACH INFLATION PRESSURE WAS 8 ATM, THE DEVICE RUPTURED AT THE FIRST INFLATION WITH PRESSURE UNKNOWN AT TIME OF RUPTURE. 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 18161741 ↗
• MalfunctionApr 1, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PINHOLE BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN A MODERATELY TORTUOUS AND MILDLY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 4.0 X 60MM, 135CM RANGER PACLITAXEL-COATED PTA BALLOON CATHETER WAS SELECTED FOR THE ENDOVASCULAR THERAPY PROCEDURE. DURING THE FIRST INFLATION AT 12 ATMOSPHERES FOR APPROXIMATELY ONE MINUTE, THE MIDDLE PART OF 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 13979924 ↗
• MalfunctionNov 11, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE BALLOON RUPTURED DURING THE PROCEDURE. A 4.0 MM X 60 MM X 135CM RANGER DRUG COATED BALLOON WAS SELECTED FOR USE IN AN ANGIOPLASTY PROCEDURE TO TREAT PERIPHERAL ARTERY DISEASE IN THE SUPERFICIAL FEMORAL ARTERY. DURING THE INITIAL INFLATION, THE BALLOON RUPTURED WHEN INFLATED TO 9 ATMOSPHERES (ATMS) FOR 20 SECONDS. PATIENT ANATOMY CONDITIONS REVEALED MODERATELY TORTUOUS ANATOMY, 75% STENOSIS AND MILD CALCIFICATION. THE DEVICE WAS REMOVED USING THE NORMAL METHOD. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12801433 ↗