ClearPoint NGS-AK-01-11-5Recalls & reported problems
Clearpoint Neuro, Inc. · SMARTFrame Accessory Kit, 5 Fr · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00850359007812), received between Nov 6, 2024 and Nov 6, 2024 — classified as 1 injury.
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
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Hematoma1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryNov 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ON (B)(6) 2024, A BILATERAL DEEP BRAIN STIMULATION (DBS) LEAD IMPLANTATION PROCEDURE WAS PERFORMED USING THE CLEARPOINT SOFTWARE VERSION 2.1 AND ASSOCIATED CLEARPOINT SYSTEM ACCESSORIES FOR PLACEMENT OF THE DBS LEADS. WHEN REVIEWING THE MRI SCANS AFTER DRILLING TWO CRANIAL BURR HOLES AND INSERTING THE STYLETS, A HEMATOMA WAS NOTED ON THE PATIENT'S LEFT SIDE. THE PATIENT WAS THEN TRANSFERRED TO THE OPERATING ROOM AND THE PROCEDURE USING CLEARPOINT NEURO'S PRODUCTS WAS ABORTED. POST-PROCEDURE, THE SURGEON CONFIRMED THAT THE CLOT WAS SUCCESSFULLY EVACUATED. CLEARPOINT NEURO PRODUCTS WERE USED AS INTENDED THROUGHOUT THE PROCEDURE.
Patient problems: Hematoma
MAUDE report 20625308 ↗
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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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