Avenir 18CFR12040Recalls & reported problems
Shanghai Wallaby Medical Technologies Co., Inc. · Embolic Coil · Class 2 · Implant
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 06970908210075), received between May 13, 2026 and May 13, 2026 — classified as 1 injury.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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
- Detachment of Device or Device Component1
Patient problems
- Foreign Body In Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMay 13, 2026Detachment of Device or Device Component
THE PATIENT WAS ADMITTED FOR THE EMBOLIZATION OF 2 INTRACRANIAL ANEURYSMS. DURING THE PROCEDURE, IT WAS IMPOSSIBLE TO DELIVER THE COIL. THE COIL STRETCHED AND COULD NOT BE COMPLETELY INSERTED INTO THE ANEURYSM. IT WAS SUBSEQUENTLY PRESSED AGAINST THE WALL OF THE PETROUS CAROTID ARTERY AND THE SUPRACLINOID INTERNAL CAROTID ARTERY BY THE PLACEMENT OF TWO STABILIZATION STENTS. INFORMATION RELATING TO THE PATIENT: IT WAS NECESSARY TO PLACE AN ADDITIONAL STENT TO TRY TO RESOLVE THE ISSUE. DUAL ANTIPLATELET THERAPY WAS ADMINISTERED TO THE PATIENT. HOSPITALIZATION WAS PROLONGED.
Patient problems: Foreign Body In Patient
MAUDE report 25157359 ↗
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- Tornado G08261Cook Incorporated · Device, Vascular, for Promoting Embolization2 recalls7 reports
- Optima Coil System OPTI0930CSFMXBalt USA LLC · Device, Vascular, For Promoting Embolization2 recalls4 reports
- Optima Coil System OPTI0720CSFMXBalt USA LLC · Device, Vascular, For Promoting Embolization2 recalls4 reports
- Optima Coil System OPTI0413CSFMXBalt USA LLC · Device, Vascular, For Promoting Embolization2 recalls3 reports
- Prestige Coil System PRES0520HPKPLBalt USA LLC · Device, Vascular, For Promoting Embolization2 recalls3 reports
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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