Rist™ 107F-079-105Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00763000413781), received between Feb 10, 2025 and Jun 16, 2025 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 16, 2025Unintended Movement; Physical Resistance/Sticking; Unintended Movement; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT AFTER GUIDING THE PHENOM 27 TO THE DISTAL END OF THE ANEURYSM, THE PIPELINE WAS INSERTED AND TRIED TO EXPAND IT FROM THE DISTAL END; THE RIST WAS STUCK IN THE PROXIMAL END, SO THE PRODUCT WAS COLLECTED. THE PIPELINE WAS USED FOR AN INDICATION THAT IS APPROVED (ON-LABEL). THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). NO PATIENT SYMPTOMS OR COMPLICATIONS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE ANEURYSM WAS LOCATED IN THE C5 CLINOID CLASSIFICATION WITH A MAX DIAMETER OF 5MM AND NECK DIAMETER OF 3MM. THERE SEEMED TO BE SOME RESISTANCE IN THE INSERTION/DURING DELIVERY. NO DEFECTS IN PARTICULAR OCCURRED WITH THE PIPELINE AND PHENOM 27. THE RIST WAS NOTED TO HAVE BEEN DROPPED TO THE PROXIMAL END. THE PHYSICIAN SAID THAT THIS WAS CAUSED BY A PROBLEM WITH THE BLOOD VESSELS. IN ORDER TO COMPLETE THE PROCEDURE, THE PHYSICIAN TRIED AGAIN WITH A FUBUKI XF AND WAS ABLE TO PLACE IT SUCCESSFULLY. ANCILLARY DEVICES INCLUDE A 107F079105 GUIDING CATHETER, PHENOM27 MICROCATHETER, SYNCHRO SELECT STANDARD GUIDEWIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22211712 ↗
• InjuryMar 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED A REPORT THAT ON DECEMBER 16 (MONDAY), TREATMENT WAS PERFORMED FOR AN UNRUPTURED ANEURYSM WITH AN IC OF 6-7 MM. PREOPERATIVE PLAN WAS AFTER PLACING 2 COILS WITH BALLOON ASSIST, THE MICROCATHETER WILL BE REPLACED AND THE PIPELINE WILL BE PLACED. THE RIST WAS SUCCESSFULLY GUIDED SMOOTHLY TO THE VICINITY OF THE CAVERNOUS AREA. AN ATTEMPT WAS MADE ABOUT 3 TIMES TO ACCESS THE ANEURYSM, AND THE MICROCATHETER WAS SUCCESSFULLY PLACED IN THE ANEURYSM. ONE APB-3-8-3D AND ONE APB-3-6-3D WERE PLACED WITH BALLOON ASSIST. UPON PERFORMING A CONTRAST IMAGING USING THE RIST, DECREASED PERIPHERAL BLOOD FLOW WAS FOUND (PERIPHERAL FROM M3). HEALTHCARE PROVIDER (HCP) COMMENTED THAT THERE WAS A POSSIBILITY THAT A THROMBUS MIGHT HAVE RELEASED WHEN INDUCED TO AN ANEURYSM USING THE MICROCATHETER. PIPELINE PLACEMENT WAS DISCONTINUED AT THE DISCRETION OF THE HCP. RE-TREATMENTIS SCHEDULED AT A LATER DATE AFTER RECOVERY OF BLOOD FLOW. 2 APB-2-3-3D WERE ADDED, AND THE PROCEDURE WAS COMPLETED. ON MARCH 10 (MONDAY), IT WAS REPORTED THAT A PATIENT IN 40S DEVELOPED A HIGH-LEVEL FUNCTIONAL DISORDER. DETAILS ARE UNKNOWN, BUT THE SYMPTOMS ARE SPEECH IMPAIRMENT AND LOWER HALF OF THE BODY PARALYSIS. T

  Patient problems: Air Embolism; Dysphasia; Nervous System Injury; Paralysis; Reduced Blood Flow

  MAUDE report 21634646 ↗
• MalfunctionFeb 10, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING AN EMERGENCY CLOT RETRIEVAL PROCEDURE, THE RIST AND RED62 KIT WERE ALLEGEDLY 'FAULTY,' RESULTING IN UNSUCCESSFUL CLOT ASPIRATION. THE PATIENT WAS ADMITTED FOR THIS PROCEDURE, AND A RIST 7F105CM GUIDE CATHETER WAS USED ALONG WITH A SELECTIVE CATHETER TO GAIN ACCESS. A RED 62 KIT WAS THEN UTILIZED, BUT THE CLOT COULD NOT BE ASPIRATED SUCCESSFULLY. SUBSEQUENTLY, A STENT RETRIEVER WAS EMPLOYED TO SUCCESSFULLY REMOVE THE CLOT. THE PATIENT RECOVERED SUCCESSFULLY, AND NO INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21344406 ↗