Renegade HI-FLORecalls & reported problems across all models

We found 7 models of Renegade HI-FLO by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 69 adverse event reports in the FDA's MAUDE database, received between Oct 9, 2018 and May 8, 2026 — classified as 6 injuries, 63 malfunctions.

The most frequently reported specific device problem is “Break” (22 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Renegade HI-FLO problems

Renegade HI-FLO models

7 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Renegade™ HI-FLO™ M001182880

  Catheter, continuous flush
  32 reports
• Renegade™ HI-FLO™ M001182890

  Catheter, continuous flush
  19 reports
• Renegade™ HI-FLO™ M001182900

  Catheter, continuous flush
  8 reports
• Renegade™ HI-FLO™ M001182850

  Catheter, continuous flush
  4 reports
• Renegade™ HI-FLO™ M001182910

  Catheter, continuous flush
  3 reports
• Renegade™ HI-FLO™ M001182840

  Catheter, continuous flush
  2 reports
• Renegade™ HI-FLO™ M001182860

  Catheter, continuous flush
  1 report

Recent Renegade HI-FLO adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionMay 8, 2026Fracture

  IT WAS REPORTED THAT A MICROCATHETER FRACTURE OCCURRED. A 135/20 RENEGADE HI FLO MICROCATHETER WAS ADVANCED FOR USE IN A MALIGNANT NEOPLASM OF THE RECTUM. NO FRACTURE WAS OBSERVED UPON OPENING THE PACKAGE OR INITIAL INSPECTION. HOWEVER, A FRACTURE WAS IDENTIFIED APPROXIMATELY 10 CM AFTER VASCULAR ENTRY DURING THE PROCEDURE. THE DEVICE WAS SUBSEQUENTLY REMOVED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25130932 ↗
• MalfunctionFeb 26, 2026Difficult to Remove; Difficult to Advance

  IT WAS REPORTED THAT DEVICE REMOVAL DIFFICULTY OCCURRED. THE TARGET LESION WAS LOCATED IN THE VESSEL IN THE LIVER. A 150/20 RENEGADE HI FLO AND A .014/190CM GW TRANSEND PERIPH WAS SELECTED FOR USE. DURING THE PROCEDURE, THE RENEGADE AND TRANSCEND DEVICES WERE UNABLE TO ADVANCE THROUGH A 5F GUIDE CATHETER AT THE PROXIMAL END, JUST BEYOND THE HUB. A NEW GUIDE WAS ATTEMPTED, BUT THE SAME ISSUE OCCURRED WITH THE FIRST RENEGADE AND TRANSCEND. NEW RENEGADE AND TRANSCEND DEVICES WERE THEN OPENED AND ADVANCES TO THE TIP OF THE 5F GUIDE, THE RENEGADE WOULD NOT ADVANCE OUT THE TIP OF THE GUIDE. IT WAS NOTED THAT THERE WERE GRITTINESS AND FRICTION DURING INSERTION AND REMOVAL. THE PROCEDURE WAS COMPLETED WITH A NON-BOSTON DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24456304 ↗
• MalfunctionFeb 25, 2026Entrapment of Device; Nonstandard Device

  IT WAS REPORTED THAT GUIDEWIRE STUCK OCCURRED. THE STENOSED TARGE LESION WAS LOCATED IN THE RENAL ARTERY. A RENEGADE? HI-FLO? CATHETER INFUSION WAS SELECTED FOR USE. DURING THE PROCEDURE, DURING THE PROCEDURE, THE CATHETER LUMEN WAS REPORTED TO BE DEFORMED, WHICH CAUSED THE GUIDEWIRE TO BECOME STUCK. THE PROCEDURE WAS COMPLETED USING 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 24444219 ↗
• MalfunctionFeb 19, 2026Fracture

  IT WAS REPORTED THAT THE DEVICE FRACTURED. THIS RENEGADE? HI-FLO? INFUSION CATHETER WAS SELECTED FOR USE DURING A PROCEDURE TO TREAT A SPLENIC HEMORRHAGE. DURING THE PROCEDURE, THE CATHETER FRACTURED. THE PROCEDURE WAS SUBSEQUENTLY COMPLETED WITH A DIFFERENT DEVICE. THE EVENT WAS RESOLVED AND THE PATIENT WAS STABLE FOLLOWING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24390110 ↗
• MalfunctionFeb 18, 2026Entrapment of Device

  IT WAS REPORTED THAT REMOVAL DIFFICULTY OCCURRED. THE 20% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED SPLENIC ARTERY. A 150/10 RENEGADE HI FLO AND 165CM TRANSEND 18 GUIDEWIRE WERE SELECTED FOR EMBOLIZATION. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). HOWEVER, DURING ADVANCEMENT, IT WAS NOTED THAT THE DEVICES BECAME STUCK WITH THE 0.038 NON-BOSTON SCIENTIFIC ANGIOGRAPHIC CATHETER AND COULD NOT BE PULLED OUT. THE DEVICES WERE THEN PULLED OUT DIRECTLY AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT, AND THE PATIENT WAS STABLE POST-PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24384072 ↗
• MalfunctionDec 11, 2025Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE TIP DETACHMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE VESSEL OF THE LOWER LIMBS. A 135/10 RENEGADE HI FLO WAS SELECTED FOR USE. DURING PREPARATION, IT WAS NOTED THAT THE DISTAL END OF THE MICROCATHETER BASE HAS A DISCONNECTION AND WAS DETACHED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE AND THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23778822 ↗
• MalfunctionNov 25, 2025Entrapment of Device; Entrapment of Device

  IT WAS REPORTED REMOVAL DIFFICULTY OCCURRED. THE 20% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND NON-CALCIFIED LIVER. A 150/10 RENEGADE HI FLO WAS SELECTED FOR USE. HOWEVER, IT WAS NOTED THAT THE MICROCATHETER BECAME STUCK IN THE HEPATIC DUCT AND COULD NOT GET OUT. THE DEVICE WAS REMOVED NORMALLY WITHOUT USING ADDITIONAL DEVICES. AND 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 23649089 ↗
• MalfunctionNov 21, 2025Entrapment of Device; Adverse Event Without Identified Device or Use Problem; Entrapment of Device; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE MICROCATHETER AND GUIDEWIRE BECAME ENTRAPPED. A RENEGADE? HI-FLO? MICROCATHETER AND A 0.016" FATHOM? GUIDEWIRE WERE SELECTED FOR USE IN A PROCEDURE. IT WAS NOTED THAT THE GUIDEWIRE BECAME STUCK IN THE MICROCATHETER. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23617022 ↗
• MalfunctionSep 15, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT COATING ISSUE OCCURRED. THE TARGET LESION WAS THE HEPATIC ARTERY. A 150/10 RENEGADE HI-FLO MICROCATHETER WAS SELECTED FOR USE FOR A Y-90 EMBOLIZATION IN THE HEPATIC ARTERY. DURING PREPARATION, THE SCRUB TECH NOTICED THAT THE OUTER COATING WAS COMING OFF OF THE MICROCATHETER. THE ITEM WAS NOT USED AND REMOVED FROM THE STERILE FIELD. THE DEVICE WAS REPLACED, AND THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23051355 ↗
• MalfunctionJun 9, 2025Break; Entrapment of Device; Material Rupture; Break; Entrapment of Device; Material Rupture

  IT WAS REPORTED THAT THE DEVICE STUCK IN SHEATH AND RUPTURED. THE STENOSED TARGET LESION WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY. A RENEGADE HI FLO WAS SELECTED FOR USE. DURING THE PROCEDURE, THE DEVICE RUPTURED UPON WITHDRAWAL. THIS MAY HAVE BEEN TO INADEQUATE FLUSHING, WHICH POTENTIALLY LED TO THE DEVICE BECOMING LODGED WITHIN THE SHEATH, RESULTING IN DEVICE RUPTURE. THE PROCEDURE WAS COMPLETED USING 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 22170856 ↗
• MalfunctionApr 11, 2025Difficult to Advance; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem; Difficult to Advance; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT COATING ISSUE OCCURRED. PATIENT WAS PRESENTED WITH HEMOPTYSIS. A 135/10 RENEGADE HI FLO WAS SELECTED FOR USE IN A PULMONARY AORTA. DURING PROCEDURE, DIFFICULTY IN MICROCATHETER DELIVERY WAS NOTED. WHEN REMOVED, IT WAS VISUALLY OBSERVED THAT THE HYDROPHILIC COATING AT THE TIP'S FRONT END HAD NOTICEABLY PEELED OFF. WHEN TOUCHED, THE DEVICE FELT OBVIOUSLY NOT SMOOTH. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21829591 ↗
• MalfunctionApr 3, 2025Fracture; Difficult to Advance; Material Integrity Problem; Fracture; Difficult to Advance; Material Integrity Problem

  IT WAS REPORTED THAT SHAFT FRACTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE PULMONARY AORTA. A 135/10 RENEGADE HI FLO WAS USED FOR TREATMENT. DURING THE PROCEDURE, IT WAS DIFFICULT TO ADVANCE THE MICROCATHETER IN THE CATHETER. A VISUAL INSPECTION SHOWS THAT THE FRONT END OF THE MICROCATHETER WAS OBVIOUSLY UNEVEN AND THE REAR END OF THE MICROCATHETER WAS FRACTURED DURING ADVANCING. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT AND THE PATIENT STATUS WAS STABLE POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21762817 ↗
• MalfunctionNov 15, 2024Defective Device; Material Deformation; Defective Device; Material Deformation

  IT WAS REPORTED THAT MARKERBAND ISSUE OCCURRED. A 135/10 RENEGADE HI-FLO WAS SELECTED FOR USE IN THE INTERVENTIONAL THERAPY FOR LIVER CANCER. DURING THE PROCEDURE, THE MARK POINT WHICH IS A RADIOGRAPHICALLY OPAQUE MARKER USED FOR LOCALIZATION WAS FOUND TO BE ABNORMAL. THE MICROCATHETER PRESSED AGAINST THE MICRO GUIDEWIRE CAUSING THE MARK POINT TO BE OUT OF POSITION. THE GUIDEWIRE AND MICROCATHETER WERE WITHDRAWN AND THE MICROCATHETER WAS FOUND TO BE KINKED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS STABLE POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20698452 ↗
• MalfunctionSep 30, 2024Break; Difficult to Remove; Difficult to Advance; Break; Difficult to Remove; Difficult to Advance

  IT WAS REPORTED THAT CATHETER BREAK OCCURRED, AND THE DEVICE WAS DIFFICULT TO REMOVE. TWO 135/10 RENEGADE HI-FLO CATHETERS WERE SELECTED FOR USE IN AN EMBOLIZATION PROCEDURE TO TREAT A GASTROINTESTINAL BLEED. DURING THE PROCEDURE, BOTH CATHETERS WERE RESISTANT DURING USE AND UPON REMOVAL. SHAFT DAMAGE WAS OBSERVED, BUT EACH DEVICE WAS REMOVED FROM THE PATIENT IN ONE PIECE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A THIRD 135/10 RENEGADE HI-FLO CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20338670 ↗
• MalfunctionSep 30, 2024Break; Difficult to Remove; Difficult to Advance; Break; Difficult to Remove; Difficult to Advance

  IT WAS REPORTED THAT CATHETER BREAK OCCURRED, AND THE DEVICE WAS DIFFICULT TO REMOVE. TWO 135/10 RENEGADE HI-FLO CATHETERS WERE SELECTED FOR USE IN AN EMBOLIZATION PROCEDURE TO TREAT A GASTROINTESTINAL BLEED. DURING THE PROCEDURE, BOTH CATHETERS WERE RESISTANT DURING USE AND UPON REMOVAL. SHAFT DAMAGE WAS OBSERVED, BUT EACH DEVICE WAS REMOVED FROM THE PATIENT IN ONE PIECE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A THIRD 135/10 RENEGADE HI-FLO CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20338225 ↗

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