RistTMRecalls & reported problems across all models

We found 3 models of RistTM by Micro Therapeutics, Inc. in the FDA's device registry (GUDID). Together they are named in 26 adverse event reports in the FDA's MAUDE database, received between Aug 1, 2022 and Aug 13, 2026 — classified as 10 injuries, 16 malfunctions.

The most frequently reported specific device problem is “Break” (20 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 RistTM problems

RistTM models

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

• RistTM 106F-071-95

  Catheter, percutaneous
  10 reports
• RistTM 106F-071-100

  Catheter, percutaneous
  10 reports
• RistTM 106F-071-105

  Catheter, percutaneous
  6 reports

Recent RistTM adverse event reports

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

• MalfunctionAug 13, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50240422 ↗
• 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 ↗
• MalfunctionJun 2, 2025Break; Material Deformation; Packaging Problem; Break; Material Deformation; Packaging Problem

  MEDTRONIC RECEIVED A REPORT THAT THERE WAS "PRODUCT BREAKAGE" WITH A RIST CATHETER.  AFTER OPENING THE PRODUCT, A KINK WAS DISCOVERED IN THE MIDDLE SECTION. THE PROBLEM WAS CONFIRMED AFTER OPENING AND BEFORE SOAKING IN THE SALINE SOLUTION. THE CAUSE WAS UNKNOWN, THOUGH IT WAS NOTED THERE WERE NO PARTICULAR PROBLEMS WITH THE HANDLING. A DIFFERENT CATHETER WAS USED INSTEAD. THE PATIENT DID NOT EXPERIENCE ANY HEALTH DAMAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22124094 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• InjuryApr 11, 2024Device Dislodged or Dislocated; Material Deformation; Physical Resistance/Sticking; Device Dislodged or Dislocated; Material Deformation; Physical Resistance/Sticking

  ADDITIONAL INFORMATION WAS RECEIVED REPORTING THE PATIENT IS CURRENTLY RECOVERING WITHOUT ISSUE POST PROCEDURE PER PHYSICIAN. THE CAUSE OF THE RESISTANCE/SEPARATION WAS NOT DETERMINED.

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

  MAUDE report 19088198 ↗
• 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 ↗

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