V-Trak 8410-0204-A2Recalls & reported problems
Microvention, Inc. · HyperSoft 3D Advanced · Class 2 · Implant
All models of V-Trak (75)
Data updated Oct 18, 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 00816777021229), received between Feb 6, 2026 and Feb 6, 2026 — classified as 1 injury.
The most frequently reported specific device problem is “Premature Separation” (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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Premature Separation1
- Separation Problem1
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.
InjuryFeb 6, 2026Separation Problem; Premature Separation
AS REPORTED THROUGH THE CLINICAL STUDY CAR: DEVICE DEFICIENCY DESCRIPTION: DURING PLACEMENT AND REPOSITIONING OF THE FINAL COIL, THE PROXIMAL ASPECT OF THE COIL BEGAN TO STRETCH. IN TRYING TO RECOVER THE COIL, THE COIL FRACTURED COMPLETELY AND SEPARATED. ADDITIONAL INFORMATION RECEIVED CLARIFIED ¿COIL FRACTURED¿ TO MEAN THE PRODUCT DETACHED WHILE IN THE PATIENT AND WAS LEFT IN THE SUBJECT. A SECOND COIL WAS DEPLOYED TO PREVENT MIGRATION/THROMBUS. PROCEDURE WAS COMPLETED SUCCESSFULLY. IT IS NOTED: DID SUBJECT REQUIRE OTHER TREATMENT/INTERVENTION AS A RESULT OF THE MALFUNCTION/DEFICIENCY THAT IS NOT ASSOCIATED WITH ANY ADVERSE EVENT? Y (YES) COULD THIS DEVICE DEFICIENCY HAVE LED TO A SERIOUS ADVERSE DEVICE EFFECT (SADE): 1. IF EITHER SUITABLE ACTION HAD NOT BEEN TAKEN, 2. IF INTERVENTION HAD NOT BEEN MADE, OR 3. IF CIRCUMSTANCES HAD BEEN LESS FORTUNATE: Y (YES) NO OTHER CLARIFICATION OR INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24284883 ↗
Other Device, Vascular, for Promoting Embolization devices
- POD RBYPOD8-APenumbra, Inc. · Device, Vascular, For Promoting Embolization195 reports
- CEREPAKTM MDH1Cerenovus, Inc. · Device, Vascular, for Promoting Embolization1 recall72 reports
- Azur CX Detachable 45-750824Microvention, Inc. · Device, Vascular, for Promoting Embolization115 reports
- 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
- Prestige Coil System PRES0520HPKPLBalt USA LLC · Device, Vascular, For Promoting Embolization2 recalls3 reports
- Optima Coil System OPTI0413CSFMXBalt 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page