Riptide™ MAC-1200Recalls & reported problems
Micro Therapeutics, Inc. · CANISTER MAC-1200 V04 NA RIPTIDE · Class 2
Data updated Oct 13, 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 00763000299422), received between Apr 22, 2022 and Apr 22, 2022 — 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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Intracranial Hemorrhage1
- Unspecified Nervous System Problem1
- Vascular Dissection1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryApr 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
MEDTRONIC RECEIVED A REPORT THAT THE PATIENT HAD A SUBARACHNOID HEMORRHAGE DISTAL TO THE M2 CLOT. THIS WAS NOTED DURING DYNA CT BEFORE GIVING ANTI-PLATELET TREATMENT. THE PATIENT HAD A MINOR HEAD INJURY AFTER A STROKE BEFORE THE INDEX ADMISSION. IN ADDITION, THE FINAL REPERFUSION MTICI SCORE WAS 0 AND THERE WAS PRESENCE OF NEUROLOGICAL DETERIORATION AT 24 HOURS POST-PROCEDURE. THE PATIENT HAD A WORSENING BASELINE NIHSS SCORE. FURTHERMORE, THE PATIENT HAD AN EXPANSION OF INDEX INFARCT ON THE 24 HOUR POST-PROCEDURE CT SCAN. THE ADVERSE EVENT WAS NOT RELATED TO THE SYSTEM OR PROCEDURE AND WAS NOT RELATED TO THE DISEASE UNDER STUDY. IN ADDITION THE ADVERSE EVENT WAS NOT RELATED TO AN UNDERLYING CONDITION OR DISEASE. THE SPONSOR ASSESSMENT DETERMINED THIS WAS A NEUROLOGICAL EVENT OF INTEREST. THE PATIENT WAS RECOVERING AT THE TIME OF THE REPORT. THE PATIENT WAS UNDERGOING TREATMENT OF THE MIDDLE CEREBRAL ARTERY, M2. THE PATIENT'S PRE-PROCEDURE MTICI SCORE WAS 0 AND THE FINAL POST-PROCEDURE MTICI SCORE WAS 0. THE PATIENT'S BASELINE MRS WAS 0 AND THE PATIENT'S NIHSS SCORE BASELINE WAS 15. AN IV TPA WAS CONTRAINDICATED AND 3 PASSES WERE MADE WITH THE DEVICE.
Patient problems: Intracranial Hemorrhage; Unspecified Nervous System Problem; Vascular Dissection
MAUDE report 14188400 ↗
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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