V-Trak 7110-0817-A2Recalls & reported problems
Microvention, Inc. · HydroFrame 10 Advanced · Class 2 · Implant
All models of V-Trak (75)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00816777023735), received between Sep 16, 2022 and May 22, 2024 — classified as 1 injury, 1 malfunction.
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
- Adverse Event Without Identified Device or Use Problem1
- Detachment of Device or Device Component1
Patient problems
- Aneurysm1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryMay 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
AS REPORTED THROUGH THE RAGE CLINICAL STUDY, EVENT TERM: ANEURYSM RECANALIZATION, EVENT #: 5 RECANALIZATION OF TREATED ANEURYSM. RETREATED WITH COILING. CONTINUE RECANALIZATION AND ONGOING MONITORING. INDEPENDENT REVIEWER (CEA) TODAY AND WAS DETERMINED TO BE DEFINITELY RELATED TO STUDY DEVICE AND PROBABLY RELATED TO STUDY PROCEDURE. EVENT START DATE: (B)(6) 2021 POST OPERATIVE DAYS: 67 DAYS. AE OUTCOME: ONGOING AS IT CANNOT BE DETERMINED WHICH COIL DEVICE OF THE (VARIOUS) COILS USED MAY HAVE IMPACTED THE ANEURYSM, MODEL 7110-0817-A2 / LOT 1810175WF WAS CHOSEN AS A DEFAULT. THE OTHER COILS USED IN THE PROCEDURE WILL BE LISTED AS CONCOMITANT DEVICES.
Patient problems: Aneurysm
MAUDE report 19373882 ↗MalfunctionSep 16, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE COIL WAS PLACED IN THE ANEURYSM AND DETACHED; HOWEVER, DURING RETRIEVAL OF THE PUSHER WIRE POST DETACHMENT, THE PHYSICIAN NOTICED A STRAND OF COIL STILL CONNECTED TO THE WIRE. THE MAJORITY OF THE COIL DETACHED AND WAS IMPLANTED, BUT ONE STRAND / COIL FIBER REMAINED ATTACHED TO THE PUSHER WIRE. FOUR (4) MORE COILS WERE PLACED AFTER, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO REPORTED INJURY OR HARM TO THE PATIENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15442846 ↗
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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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