Rist™ 107F-079-95Recalls & reported problems
Micro Therapeutics, Inc. · SHEATH RADIAL LONG 107F-079-95 V01 US · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00763000413767), received between Jul 16, 2024 and Jul 16, 2024 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Break” (1 report).
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.
Reports received per month
Most reported problems
Device problems
- Break1
- Difficult to Advance1
Patient problems
- Device Embedded In Tissue or Plaque1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJul 16, 2024
RADIAL ACCESS GUIDE CATHETER WOULD NOT ADVANCE IN BRACHIAL ARTERY. UPON REMOVAL, THE CATH STARTED TO UNWIND AND TIP BROKE OFF. X-RAY IMAGES CONFIRMED TIP IN VESSEL. UPON COMPLETION OF NEURO INTERVENTION, THE PATIENT WAS TAKEN TO THE OR (OPERATING ROOM) FOR SUCCESSFUL RETRIEVAL OF CATHETER BY VASCULAR SURGEON.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 19749744 ↗MalfunctionJul 16, 2024Break; Difficult to Advance; Break; Difficult to Advance
MEDTRONIC RECEIVED INFORMATION THAT A RIST CATHETER WAS BROKEN. THE CATHETER BROKE DURING USE. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19747463 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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