RistTM 106F-071-95Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00763000541194), received between Sep 13, 2022 and Aug 4, 2026 — classified as 5 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Break” (7 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryAug 4, 2026Break; Difficult to Remove

  Medtronic received a report that when the Hospital / lab was done with stroke treatment and trying to remove the RIST catheter, it fractured. A Vascular Surgeon tried pulling it out from the wrist but it did not work. The interventional team went through the groin and tried to snare the RIST but this also did not work. The distal tip of the RIST broke off from the catheter. The RIST catheter remains in the patient.

  Patient problems: Foreign Body In Patient; Vasoconstriction

  MAUDE report 50126702 ↗
• MalfunctionMay 22, 2026Material Deformation; Packaging Problem

  MEDTRONIC RECEIVED A REPORT THAT A RIST CATHETER WAS DAMAGED OUT OF PACKAGING. A KINK WAS OBSERVED. NO PATIENT COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE DAMAGE WAS ON THE PACKAGED INTRODUCER GUIDE. THE CAUSE OF THE EVENT WAS DETERMINED TO BE KINKED UPON DELIVERY. ALL INFORMATION HAD BEEN CONFIRMED/PROVIDED BY THE PHYSICIAN. ADDITIONAL INFORMATION RECEIVED. FACILITY NAME AND ADDRESS WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25257696 ↗
• InjuryDec 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT A PATIENT TREATED WITH A PED2 PIPELINE STENT HAD A HEADACHE AND LIGHT SENSITIVITY AND VISION BECOMING BLURRY WITH BRIGHT LIGHT. INTERMITTENT FLASHES OF LIGHTS IN THE PERIPHERAL VISION-MAINLY ON THE LEFT SIDE. STATES SHE HAS INTERMITTENT, DULL, ACHING FRONTAL HEADACHE. THE PATIENT WAS HOSPITALIZED. THE EVENT RESOLVED ON 2023-FEB-14. POSSIBLY DEVICE AND PROCEDURE RELATED. MRI WAS POSITIVE FOR T2 FLAIR AS WELL AS MULTIPLE SMALL SUBACUTE INFARCT POSSIBLE SUBACUTE ISCHEMIA. THE PATIENT WAS BEING TREATED FOR AN ANEURYSM IN THE INTERNAL CAROTID ARTERY (ICA), C6 SEGMENT. LOCATION OF ANEURYSM IN VESSEL: SIDEWALL. ANEURYSM MORPHOLOGY: SACCULAR. MAXIMUM ANEURYSM DIAMETER: 8.5MM. ANEURYSM DOME HEIGHT: 6MM. ANEURYSM DOME WIDTH: 5MM. ANEURYSM NECK SIZE: 3.8MM. PARENT ARTERY DIAMETER DISTAL TO ANEURYSM: 3.2MM. PARENT ARTERY DIAMETER PROXIMAL TO ANEURYSM: 3.7MM. NO STASIS AT THE END OF THE PROCEDURE. COMPLETE NECK COVERAGE AT THE END OF THE PROCEDURE. RAYMOND AND ROY OCCLUSION CLASS 3 AT THE END OF THE PROCEDURE. ACCESS VIA RADIAL RIGHT. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT WAS HOSPITALIZED FROM FEBRUARY (B)(6) 2023. THE PATIENT WAS GIVEN ATORVAS

  Patient problems: Blurred Vision; Headache; Ischemia; Stroke/CVA; Visual Disturbances

  MAUDE report 23795282 ↗
• MalfunctionOct 20, 2025Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING A RIST CATHETER, IT WAS NOTICED THE HUB WAS BREAKING WHEN THE TECHNICAL WAS ABOUT TO LOAD THE NON-MEDTRONIC CATHETER BACK INTO THE RIST. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THE EVENT, AND THE PATIENT OUTCOME WAS REPORTED AS ALIVE WITH NO INJURY. ADDITIONAL INFORMATION RECEIVED REPORTED THE BREAKING WAS COMPLETELY AT THE HUB WHERE THERE WAS SEPARATION. THE PHYSICIAN JUST TRIED TO USED THE CATHETER IT JUST BROKE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23342270 ↗
• InjuryApr 3, 2025Break; Stretched; Break; Stretched

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT RECEIVED THE ANTISPASMODIC MEDICATION PRIOR TO INSERTION OF THE RIST CATHETER.

  Patient problems: Foreign Body In Patient; Vasoconstriction

  MAUDE report 21765506 ↗
• MalfunctionMar 27, 2025Break; Packaging Problem; Break; Packaging Problem

  IT WAS REPORTED THAT THE HUB WAS NOT ATTACHED TO THE CATHETER FOR THE CATHETER RADIAL GUIDE 106F-071-95. THIS ISSUE OCCURRED TWICE WHEN THE PHYSICIAN REMOVED THE 6F RIST CATHETER FROM THE PACKAGING AND NOTICED THE HUB WAS NOT ATTACHED. THE PHYSICIAN DISCARDED THE FIRST UNIT, OPENED ANOTHER FROM THE SAME LOT, AND ENCOUNTERED THE SAME ISSUE. NEITHER DEVICE WAS USED IN THE PROCEDURE, AND THE PHYSICIAN OPTED TO UTILIZE A COMPETITIVE GUIDE SHEATH TO COMPLETE THE CASE. THERE WAS NO PATIENT INVOLVED. ADDITIONAL INFORMATION WAS RECEIVED THAT THERE WAS NO DAMAGE OR EVIDENCE OF TAMPERING TO DEVICE PACKAGING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21713469 ↗
• MalfunctionMar 27, 2025Break; Packaging Problem; Break; Packaging Problem

  IT WAS REPORTED THAT THE HUB WAS NOT ATTACHED TO THE CATHETER FOR THE CATHETER RADIAL GUIDE 106F-071-95. THIS ISSUE OCCURRED TWICE WHEN THE PHYSICIAN REMOVED THE 6F RIST CATHETER FROM THE PACKAGING AND NOTICED THE HUB WAS NOT ATTACHED. THE PHYSICIAN DISCARDED THE FIRST UNIT, OPENED ANOTHER FROM THE SAME LOT, AND ENCOUNTERED THE SAME ISSUE. NEITHER DEVICE WAS USED IN THE PROCEDURE, AND THE PHYSICIAN OPTED TO UTILIZE A COMPETITIVE GUIDE SHEATH TO COMPLETE THE CASE. THERE WAS NO PATIENT INVOLVED. ADDITIONAL INFORMATION WAS RECEIVED THAT THERE WAS NO DAMAGE OR EVIDENCE OF TAMPERING TO DEVICE PACKAGING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21713453 ↗
• InjuryJan 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED REPORTING THE CAUSE OF THE EVENT WAS NOT DETERMINED. THIS INFORMATION HAS BEEN CONFIRMED WITH THE PHYSICIAN. ADDITIONAL INFORMATION WAS RECEIVED REPORTING THE ADVERSE EVENT (AE) WAS NOT RELATED TO THE DISEASE UNDER STUDY. THE SITE ASSESSED THIS EVENT AS NOT RELATED TO ANTIPLATELET MEDICATION OR DEVICE AND POSSIBLY RELATED TO THE STUDY PROCEDURE.

  Patient problems: Bacterial Infection; Headache; Pain; Vasoconstriction

  MAUDE report 21273193 ↗
• MalfunctionDec 7, 2023Break; Stretched; Material Deformation; Break; Stretched; Material Deformation

  ADDITIONAL INFORMATION RECEIVED THAT THE PATIENT WAS UNDERGOING A MIDDLE MENINGEAL ARTERY (MMA) EMBOLIZATION. THE PATIENT'S VESSEL TORTUOSITY WAS MINIMAL. THE CATHETER BROKE IN THE MIDDLE SECTION. THE CATHETER DID NOT SEPARATE INTO MULTIPLE PIECES. THE CATHETER BROKE UPON REMOVAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18287476 ↗
• InjurySep 13, 2022Break; Burst Container or Vessel; Material Deformation; Break; Burst Container or Vessel; Material Deformation

  MEDTRONIC RECEIVED INFORMATION THAT A RIST CATHETER SEPARATED IN THE DISTAL SECTION DUE TO ENTRAPMENT IN ONYX. THE PHYSICIAN WENT RADIAL FOR THE INTERVENTION WITH 6F RIST 106F-071-95 AND IT ENDED UP KINKING AT THE ARCH. ONYX 18 WAS USED TO EMBOLIZE THE MIDDLE MENINGEAL ARTERY AND HEADWAY DUO WAS USED AS HIS MICROCATHETER. WHEN TRYING TO REMOVE THE HEADWAY DUO THE PHYSICIAN NOTICED IT WAS STUCK IN THE ONYX CAST AND AT THIS POINT HE DIDN'T REALIZE THAT RIST HAD KINKED. THE PHYSICIAN PULLED THE HEADWAY DUO SLIGHTLY AND LOCKED THE TOUEY IN HOPES THAT THE HEADWAY DUO WOULD RELEASE FROM THE ONYX CAST. HE DID THIS SEVERAL TIMES AND WHILE DOING THIS THE HEADWAY DUO FRACTURED AROUND THE MID BODY OF THE CATHETER. THE PHYSICIAN PULLED OUT THE PROXIMAL HALF OF THE HEADWAY DUO AND THEN REMOVED RIST WHICH IS WHEN THE PHYSICIAN NOTICED RIST WAS KINKED. WITH THE DISTAL HALF OF HEADWAY DUO WAS STILL IN THE PATIENT THE PHYSICIAN HAD TO USE A MICROSNARE TO REMOVE IT FIRST FROM THE ONYX CAST AND THEN FROM THE PATIENT. THE PATIENT WAS DISCHARGED THE NEXT DAY. DISTAL PORTION OF HEADWAY DUO STUCK IN ONYX CAST AND MIDDLE PORTION POSSIBLY ENTRAPPED IN THE KINK OF RIST PER PHYSICIAN. THE CATHETER WAS ENTRAP

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

  MAUDE report 15414435 ↗