Avenir 10CSW02020Recalls & reported problems
Shanghai Wallaby Medical Technologies Co., Inc. · Class 2 · Implant
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 06970908212840), received between Dec 17, 2025 and Dec 17, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Stretched” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Stretched1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryDec 17, 2025Stretched; Stretched
PROCEDURE WAS AN MMA EMBOLIZATION. COIL WAS THE LAST ONE IN. COIL WAS PARTIALLY IN PLACE WHEN THE BENCHMARK FELL DOWN DRAGGING THE COIL IN TO THE INTERNAL CAROTID ARTERY. COIL RETRIEVEL WAS ATTEMPTED, BUT STRETCHED IN THE PROCESS CAUSING FILAMENT TO BE IN THE ICA. SCEPTER BALLOON WAS USED TO PUSH FILAMENT BACK INTO ECA. FILAMENT WAS LATER SURGICALLY REMOVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23825734 ↗
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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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