Ranger™ H74939419700410Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 08714729976240), received between Aug 5, 2022 and Feb 13, 2026 — classified as 5 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Failure to Deflate” (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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 13, 2026Material Rupture; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE BALLOON WAS RUPTURED AND EMBOLISM OCCURRED, REQUIRING INTERVENTION. THE TARGET LESION WAS LOCATED IN A MODERATELY TORTUOUS AND MODERATELY CALCIFIED VESSEL. A 7.0 X 40MM, 135CM RANGER BALLOON CATHETER WAS SELECTED FOR USE. THE BALLOON WAS SUCCESSFULLY INFLATED FOR THE FIRST TIME THEN REPOSITIONED. DURING THE SECOND INFLATION, HOWEVER, THE BALLOON RUPTURED AT 10 ATMOSPHERES. IT WAS DETERMINED THAT A BALLOON FRAGMENT DETACHED IN THE VESSEL. SNARING WAS ATTEMPTED TO RETRIEVE THE DETACHED FRAGMENT, BUT THE ATTEMPTS WERE UNSUCCESSFUL. THE FRAGMENT EMBOLIZED IN A SMALL COLLATERAL VEIN. THE EMBOLIZED FRAGMENT WAS ESTIMATED TO HAVE NO NEGATIVE IMPACT ON THE PATIENT, AND THE PATIENT WAS FULLY RECOVERED.

  Patient problems: Embolism/Embolus; Foreign Body In Patient

  MAUDE report 24332644 ↗
• InjuryJul 18, 2025Adverse Event Without Identified Device or Use Problem; Failure to Deflate; Adverse Event Without Identified Device or Use Problem; Failure to Deflate

  IT WAS REPORTED THAT THE BALLOON WOULD NOT DEFLATE, RESULTING IN PUNCTURE OF THE BALLOON WITH A NEEDLE. THE TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED ARTERIOVENOUS FISTULA IN THE ARM. A 7.0 X 40MM, 135CM RANGER DRUG-COATED BALLOON WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE BALLOON WOULD NOT DEFLATE. THE PHYSICIAN ULTIMATELY PUNCTURED THE BALLOON DIRECTLY USING A NEEDLE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22543473 ↗
• MalfunctionMay 29, 2025Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED VIA A GOOD LABORATORY PRACTICE (GLP) STUDY THAT STERILITY WAS COMPROMISED DUE TO DAMAGED DEVICE PACKAGING. ONE 7.0 X 40MM, 135CM RANGER DRUG-COATED BALLOON (DCB) WAS REMOVED FROM THE COMMERCIAL LABELED BOX TO INTRODUCE TO AN ANIMAL SUBJECT. UPON REMOVAL AND PRIOR TO USE, HOWEVER, IT WAS OBSERVED THAT THE INNER PACKAGE WAS PUNCHED, MAKING THE DEVICE UNSTERILE AND UNUSABLE. AFTER THIS OBSERVATION, THE REST OF THE REMAINING UNUSED RANGER DCBS WERE INSPECTED PRIOR TO USE. IN ADDITION TO THE FIRST RANGER DCB, FOUR MORE RANGER DCBS WERE ALSO IDENTIFIED TO HAVE DAMAGED INNER PACKAGING. THERE WERE 3 FROM LOT 2440H24 AND 2 FROM LOT 04347H24. THE DEVICES WERE NOT USED IN THE GLP STUDY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22106953 ↗
• MalfunctionMay 29, 2025Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED VIA A GOOD LABORATORY PRACTICE (GLP) STUDY THAT STERILITY WAS COMPROMISED DUE TO DAMAGED DEVICE PACKAGING. ONE 7.0 X 40MM, 135CM RANGER DRUG-COATED BALLOON (DCB) WAS REMOVED FROM THE COMMERCIAL LABELED BOX TO INTRODUCE TO AN ANIMAL SUBJECT. UPON REMOVAL AND PRIOR TO USE, HOWEVER, IT WAS OBSERVED THAT THE INNER PACKAGE WAS PUNCHED, MAKING THE DEVICE UNSTERILE AND UNUSABLE. AFTER THIS OBSERVATION, THE REST OF THE REMAINING UNUSED RANGER DCBS WERE INSPECTED PRIOR TO USE. IN ADDITION TO THE FIRST RANGER DCB, FOUR MORE RANGER DCBS WERE ALSO IDENTIFIED TO HAVE DAMAGED INNER PACKAGING. THERE WERE 3 FROM LOT 2440H24 AND 2 FROM LOT 04347H24. THE DEVICES WERE NOT USED IN THE GLP STUDY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22106811 ↗
• InjuryJul 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT RESTENOSIS OCCURRED REQUIRING INTERVENTION. THIS 7.0 X 40MM, 135CM RANGER PACLITAXEL-COATED PTA BALLOON CATHETER WAS SELECTED FOR USE IN A LEFT LEG REVASCULARIZATION PROCEDURE. THE LESION WAS LOCATED IN THE SEVERELY STENOSED LEFT COMMON FEMORAL ARTERY INCLUDING PROXIMAL ANASTOMOSIS OF THE COMMON FEMORAL TO BELOW-KNEE POPLITEAL VEIN BYPASS. AN ATHERECTOMY DEVICE WAS USED TO TREAT THE COMMON FEMORAL ARTERY AND PROXIMAL ANASTOMOSIS OF VEIN BYPASS. THEN THIS BALLOON WAS USED TO TREAT THE ANASTOMOSIS. APPROXIMATELY FIVE MONTHS LATER, HIGH GRADE RESTENOSIS OF THE PROXIMAL ANASTOMOSIS WAS IDENTIFIED. THE LESION WAS AGAIN TREATED WITH AN ATHERECTOMY DEVICE FOLLOWED BY BALLOON ANGIOPLASTY. NO FURTHER PATIENT COMPLICATIONS WERE NOTED.

  Patient problems: Restenosis

  MAUDE report 17352399 ↗
• InjuryJan 23, 2023Difficult to Remove; Detachment of Device or Device Component; Failure to Deflate; Difficult to Remove; Detachment of Device or Device Component; Failure to Deflate

  IT WAS REPORTED THAT THE BALLOON CATHETER WAS NOT FULLY DEFLATING AND BECAME SHEARED, RESULTING IN AN ADDITIONAL INTERVENTION. THIS RANGER GLOBAL DCB OTW 7.0 X 40MM, 135CM WAS SELECTED FOR USE IN A RIGHT COMMON ILIAC ANGIOPLASTY PROCEDURE FOR IN STENT RESTENOSIS. THE LESION WAS INITIALLY DILATED WITH A NON BOSTON SCIENTIFIC BALLOON, THEN THIS RANGER BALLOON WAS USED FOR THREE MINUTES, REACHING A BURST PRESSURE OF 14 ATM. THE DISTAL 10MM OF BALLOON WAS NOT DEFLATING COMPLETELY. SEVERAL ATTEMPTS WERE MADE TO SLIGHTLY REINFLATE THEN DEFLATE THE BALLOON WITHOUT SUCCESS. IT WAS NOTED THAT THE DEVICE WAS DIFFICULT TO REMOVE FROM THE SHEATH. THE SHEATH, WIRE, AND BALLOON WERE REMOVED TOGETHER, LEAVING A BUDDY WIRE IN PLACE TO RETAIN ACCESS. UPON INSPECTION, THE BALLOON HAD SHEARED AND THE 5MM DISTAL TIP WAS PARTIALLY CAUGHT IN THE FEMORAL ARTERIOTOMY. THE BALLOON PROCEDURE WAS COMPLETED, AND THE PATIENT WAS TRANSFERRED TO THE OPERATING ROOM TO REMOVE THE PORTION OF BALLOON MATERIAL. THEY WERE ADMITTED TO THE HOSPITAL FOLLOWING THE PROCEDURE AND WERE EXPECTED TO FULLY RECOVER. THE PRODUCT IS EXPECTED TO BE RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16224264 ↗
• MalfunctionDec 14, 2022Failure to Deflate; Failure to Deflate

  IT WAS REPORTED FROM MEDWATCH REPORT (B)(4) THAT BALLOON WOULD NOT FULLY DEFLATE. A RANGER PACLITAXEL-COATED BALLOON CATHETER 7.0 X 40MM, 135CM WAS SELECTED FOR THIS A/V DIALYSIS GRAFT/FISTULA AND ANGIOPLASTY PROCEDURE. THE INTERVENTIONAL RADIOLOGIST DEPLOYED AND INFLATED THE BALLOON TO 6 ATM PRESSURE (HELD FOR 3 MINUTES) THEN DEFLATED. UPON TRYING TO RETRACT THE BALLOON, IT WAS DISCOVERED THAT IT WAS NOT FULLY DEFLATED. THE TECHNICIAN AGAIN ATTEMPTED TO DEFLATE THE BALLOON, HOWEVER, AS THE BALLOON REACHED THE SHEATH IT WOULD NOT SQUEEZE THROUGH THE SHEATH. THE PHYSICIAN PULLED THE SHEATH OUT WITH THE BALLOON (LEAVING A WIRE IN PLACE). ACCESS WITH A NEW SHEATH WAS OBTAINED AND A SUBSEQUENT BALLOON PROCEDURE WAS PERFORMED SUCCESSFULLY WITHOUT SEQUELA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15978415 ↗
• InjuryAug 5, 2022Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT THE BALLOON WOULD NOT DEFLATE, AND SOME BALLOON MATERIAL WAS LEFT IN THE PATIENT. A 7.0MM X 40MM, 135CM RANGER PACLITAXEL-COATED PTA BALLOON CATHETER WAS SELECTED FOR USE IN A PERIPHERAL INTERVENTION OF THE EXTERNAL ILIAC ARTERY. DURING THE PROCEDURE, THE BALLOON WAS INFLATED AT 8ATM FOR THREE MINUTES, BUT THE BALLOON WOULD DEFLATE FOLLOWING DILATION. A NEEDLE WAS USED TO POP THE BALLOON, BUT SOME OF THE BALLOON MATERIAL WAS LEFT INSIDE THE PATIENT. THE PATIENT WAS TAKEN TO THE OR TO OPEN UP THE ARTERY AND RETRIEVE THE REST OF THE DEVICE. THE PROCEDURE WAS NOT COMPLETED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 15175693 ↗