RistTM 106F-071-105Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00763000541217), received between Feb 9, 2023 and Apr 2, 2025 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Break” (6 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.

• MalfunctionApr 2, 2025Break; Fracture; Material Deformation; Break; Fracture; Material Deformation

  IT WAS REPORTED THAT DURING A NEUROVASCULAR PROCEDURE INVOLVING THE CATHETER RADIAL GUIDE, SEVERAL ISSUES WERE OBSERVED. THE HUB BROKE OFF FROM THE CATHETER WHERE THE WHITE HUB ENDS ON THE BACK TABLE. ADDITIONALLY, THE DEVICE HAD A KINK ON THE PROXIMAL END NEAR THE HUB, AND BLOOD WAS NOTICED COMING FROM THE DISTAL END OF THE DEVICE. THE DEVICE WAS ALSO CRACKED ON THE PROXIMAL END NEAR THE HUB. DESPITE THESE ISSUES, THE PROCEDURE WAS COMPLETED SAFELY WITHOUT INJURY TO THE PATIENT, AND THE CATHETER WAS REMOVED AS SOON AS POSSIBLE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21753801 ↗
• MalfunctionApr 2, 2025Break; Fracture; Material Deformation; Break; Fracture; Material Deformation

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PHYSICIAN PLACED AN EXCHANGE WIRE IN THE PATIENT AND SWITCHED OUT THE CATHETER WITH ANOTHER RIST CATHETER TO RESOLVE THE CATHETER/HUB BREAK. THE DEVICE HAD A CRACK ON THE PROXIMAL END SO BLOOD WAS LEAKING OUT OF THE SIDE OF THE CATHETER. THE ACTUAL CAUSE WAS NOT DETERMINED. TWO OTHER RIST CATHETERS THAT WERE BROKEN OR KINKED GETTING PULLED OUT OF THE PACKAGE WERE ALSO NOTED. IT WAS MOST LIKELY THE CAUSE OF THE BREAK IN THE CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21753788 ↗
• MalfunctionNov 8, 2024Break; Leak/Splash; Break; Leak/Splash

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE CAUSE OF THE CATHETER SEPARATION/BREAK AND LEAK WAS NOT DETERMINED. IT WAS CLARIFIED THAT THE BREAK AND LEAK OCCUR AT THE HUB THAT CONNECTS TO THE CATHETER. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EVENT/INJURY STOPPING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20640899 ↗
• MalfunctionApr 5, 2024Break; Packaging Problem; Break; Packaging Problem

  ADDITIONAL INFORMATION RECEIVED REPORTED THERE WAS NO EVIDENCE OF OF TAMPERING AND BOX AND PACKAGING LOOKED UNDAMAGED AS WELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19052732 ↗
• MalfunctionOct 4, 2023Break; Break

  MEDTRONIC RECEIVED A REPORT THAT AS THE RIST CATHETER WAS BEING ADJUSTED, IT SNAPPED. THERE WAS NO FRICTION OR DIFFICULTY DURING INJECTION. THERE WAS NO FORCE APPLIED DURING DELIVERY/REMOVAL. THE RIST TIP WAS NOT ENTRAPPED AND THERE WAS NO VASOSPASM. THE RIST WAS NOT STUCK INSIDE OF THE GUIDE CATHETER. THERE WAS NO ADDITIONAL SURGICAL OR MEDICINAL INTERVENTION REQUIRED. THE BREAK WAS IN THE PROXIMAL SECTION. THE RIST AND ANY ACCESSORIES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE RIST WAS FLUSHED AS INDICATED IN THE IFU. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.   THE PATIENT WAS UNDERGOING SURGERY FOR RADIAL ACCESS FOR A PIPELINE PLACEMENT. THE ACCESS VESSEL WAS THE RADIAL ARTERY. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. ANCILLARY DEVICES INCLUDE A PHENOM 27.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17869351 ↗
• MalfunctionFeb 9, 2023Break; Difficult to Remove; Break; Difficult to Remove

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE HCP ROUTINELY USES ANGIO BEFORE INTRODUCING RIST AND ANGIO WAS USED PRIOR TO RIST INTRODUCTION IN THIS CASE; ARTERY WITH NO ABERRANT ANATOMY, 2MM IN SIZE AND THE PATIENT JUST DEVELOPED SPASM DURING THE PROCEDURE. ANGIOGRAPHY OF RADIAL ARTERY WAS DONE AFTER 6 FR SHEATH WAS PLACED AND AGAIN WHEN THE CATHETER WAS STUCK AND SAW SPASM. IT WAS NOTED THAT THE HCP TYPICALLY USED ULTRASOUND FOR RIST, AND ULTRASOUND WAS USED TO MEASURE RADIAL ARTERY IN THIS CASE; 2MM ARTERY.

  Patient problems: Device Embedded In Tissue or Plaque; Vasoconstriction

  MAUDE report 16342271 ↗