RistTM 106F-071-100Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00763000541200), received between Aug 1, 2022 and Aug 13, 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.

• MalfunctionAug 13, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50240422 ↗
• 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 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 ↗
• InjuryDec 18, 2023Break; Material Deformation; Physical Resistance/Sticking; Break; Material Deformation; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT VENOUS SINUS STENTING, THE PATIENT HAD A HIGH JUGULAR BULB WITH SIGNIFICANT TORTUOSITY; THEY HAD TO PUSH THE RIST THROUGH THE STENOSIS AND THINK THE CATHETER POSSIBLY KINKED DISTALLY. WHEN PUSHING OUT THE ZILVER STENT, IT FELT DIFFICULT, AND WHEN THEY TRIED TO PULL EVERYTHING OUT, IT SHEERED OFF THE DISTAL END OF THE RIST AND 3MAX. THEY STILL ENDED UP TREATING THE PATIENT AND THE STENT TACKED DOWN THE FRAGMENTS AGAINST THE OUTER WALL OF THE SINUS. THE PATIENT IS DOING OKAY. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 18347452 ↗
• MalfunctionSep 22, 2023Leak/Splash; Material Deformation; Leak/Splash; Material Deformation

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE KINK WAS FIRST NOTICED WHEN THEY FOUND THAT THE CONTRAST VOLUME SHOWED IN FLUOROSCOPY DIDN'T MATCH WITH THE INJECTED VOLUME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17803416 ↗
• MalfunctionJun 1, 2023Material Deformation; Material Integrity Problem; Material Deformation; Material Integrity Problem

  ADDITIONAL INFORMATION RECEIVED REPORTED THERE WAS NO ISSUES NOTICED UPON OPENING THE PACKAGE. NORMAL PREPERATION PER INSTRUCTIONS FOR USE (IFU). NO ISSUES WERE SEEN. THERE WERE NO ISSUES THAT RESULTED IN THE DAMAGE THAT WAS SEEN . THERE WAS NO DAMAGE OR EVIDENCE OF TAMPERING TO DEVICE PACKAGING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17040030 ↗
• InjuryDec 2, 2022Break; Difficult to Remove; Stretched; Break; Difficult to Remove; Stretched

  MEDTRONIC RECEIVED A REPORT THAT THE RIST CATHETER BECAME ENTRAPPED/HAD A DIFFICULT REMOVAL AND BROKE REQUIRING AN ADDITIONAL SURGICAL INTERVENTION. THE PATIENT WAS UNDERGOING TREATMENT FOR ANEURYSM COIL EMBOLIZATION. THE ACCESS VESSEL WAS THE RIGHT RADIAL ARTERY, WHICH WAS 2.1MM IN DIAMETER. IT WAS REPORTED THAT EXTREME VASOSPASM OCCURRED AFTER EXCHANGING A 5F DIAGNOSTIC CATHETER OUT FOR THE 6F RIST. DURING THE EXCHANGE THERE WAS TENSION NOTED IN THE SYSTEM. ONCE THE CATHETER WAS DEEMED TO BE "LOCKED" INTO THE RADIAL/BRACHIAL ARTERIES, VARIOUS MANEUVERS WERE ATTEMPTED TO GET THE ARTERIES TO "RELEASE" THE CATHETER. RESCUE MANEUVERS WERE SAID TO BE EXTRAVASCULAR LIDOCAINE INJECTED SUBCUTANEOUSLY ALONG THE LENGTH OF THE ARTERIES, WARM COMPRESS, AND A BLOOD PRESSURE CUFF VASODILATION MANEUVER. ONCE THESE MANEUVERS WERE UNSUCCESSFUL, ATTEMPTS WERE MADE USING A SNARE DEVICE. ONCE THE SNARE TECHNIQUE WAS UNSUCCESSFUL, VASCULAR SURGERY WAS CONSULTED AND THE PATIENT WAS TAKEN TO THE OPERATING ROOM WHERE A CUT-DOWN OF THE ARM WAS PERFORMED IN ORDER TO REMOVE ALL FOREIGN BODIES OF AND ASSOCIATED WITH THE RIST CATHETER. IT WAS NOTED THAT THERE WAS CATHETER SEPARATION/BREAK, AND THE CATHETER S

  Patient problems: Vasoconstriction

  MAUDE report 15911753 ↗
• InjurySep 8, 2022Break; Difficult to Advance; Break; Difficult to Advance

  ADDITIONAL INFORMATION RECEIVED REPORTED THE CAUSE OF THE EVENT WAS THE DEVICE BROKE IN THE PATIENT'S ARTERY.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 15380493 ↗
• MalfunctionAug 9, 2022Break; Entrapment of Device

  AFTER RADIAL ACCESS OBTAINED, ATTEMPTED TO ADVANCE RIST CATHETER INTO RADIAL ARTERY. DIFFICULTY NOTED IN ADVANCING CATHETER, WHICH WAS IN AN ACCESSORY RADIAL ARTERY. ATTEMPTED TO WITHDRAW CATHETER, AT WHICH TIME A DISTAL FRAGMENT OF THE CATHETER BROKE OFF AND WAS LODGED IN THE ACCESSORY RADIAL ARTERY. DECISION WAS MADE IT WOULD BE MORE DANGEROUS TO ATTEMPT TO RETRIEVE THE FRAGMENT (WITH RISK OF VESSEL RUPTURE) RATHER TO KEEP FRAGMENT IN PLACE. SUCCESSFULLY USED BENCHMARK GUIDE CATHETER TO FINISH TREATING ANEURYSM. PATIENT AWOKE WITH NO NEW DEFICITS OR COMPLICATIONS.

  Patient problems: Foreign Body In Patient

  MAUDE report 15191643 ↗
• InjuryAug 1, 2022Break; Difficult to Advance; Break; Difficult to Advance

  MEDTRONIC RECEIVED INFORMATION REGARDING A RIST 6F CATHETER THAT HAD RESISTANCE DURING DELIVERY AND BROKE/SEPARATED. THE PATIENT WAS UNDERGOING PROCEDURE FOR ANEURYSM EMBOLIZATION IN THE RIGHT INTERNAL CAROTID ARTERY VIA RADIAL ACCESS. VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT THE RIST CATHETER AND ALL ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE CATHETER WAS FLUSHED PER IFU. THE PHYSICIAN WAS ADVANCING THE RIST CATHETER IN THE RADIAL ARTERY THROUGH A SHORT SHEATH. AFTER APPROXIMATELY 15-20% OF THE CATHETER WAS ADVANCED, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE REMOVED THE CATHETER WHICH STRETCHED DURING REMOVAL AND THE DIAL 15CM OF THE CATHETER SEPARATED FROM THE SHAFT AND WAS LODGED IN AN ACCESSORY ARTERY. IT WAS NOTED THAT THE CATHETER TIP WAS NOT STUCK/ENTRAPPED AND FORCE WAS NOT APPLIED DURING DELIVERY OR REMOVAL. IT WAS DECIDED TO LEAVE THE DETACHED CATHETER SEGMENT WHERE IT WAS RATHER THAN RETRIEVE IT IN ORDER TO PREVENT FURTHER INJURY TO THE PATIENT. A DIFFERENT CATHETER WAS THEN PLACED AND THE PHYSICIAN WAS ABLE TO COMPLETE THE REST OF THE PROCEDURE AS PLANNED. IT WAS NOTED THAT THERE WAS NOT RESISTANCE IN THE GUIDE CAT

  Patient problems: Device Embedded In Tissue or Plaque; Vasoconstriction

  MAUDE report 15141064 ↗