HydroFrame Framing Coil 181243HFRM-V-A2Recalls & reported problems
Microvention, Inc. · V-Trak · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00816777023834), received between Sep 25, 2019 and Apr 10, 2023 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 reports).
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.
Most reported problems
Device problems
- Detachment of Device or Device Component2
- Premature Separation1
- Separation Failure1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 10, 2023Premature Separation; Premature Separation
IT WAS REPORTED THAT THE THE EMBOLIZATION COIL WAS USED TO TREATED A PATIENT WITH UNSPECIFIED LARGE ANEURYSM. REPORTEDLY, THE COIL UNINTENTIONALLY DETACHED IN THE MICROCATHETER DURING RE-POSITIONING ATTEMPT. THE ENTIRE COIL WAS REMOVED FROM THE PATIENT AND DIFFERENT BRAND COIL WAS USED TO SUCCESSFULLY COMPLETE THE CASE. THE PATIENT WAS FINE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16709568 ↗MalfunctionNov 4, 2020Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT AN EMBOLIZATION COIL UNEXPECTEDLY DETACHED FROM ITS DELIVERY SYSTEM IN THE MICROCATHETER PRIOR TO DEPLOYMENT. THE COIL WAS REMOVED IN ITS ENTIRETY TOGETHER WITH THE MICROCATHETER. THERE WAS NO REPORTED PATIENT INJURY OR ADDITIONAL INTERVENTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10785855 ↗MalfunctionSep 25, 2019Separation Failure; Detachment of Device or Device Component; Separation Failure; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING EMBOLIZATION OF AN ANEURYSM, THE IMPLANT COIL DID NOT DETACH. WHEN THE DEVICE WAS WITHDRAWN, THE IMPLANT COIL DETACHED. THE DELIVERY PUSHER APPEARED DAMAGED. THE IMPLANT WAS LEFT IN THE ANEURYSM. THERE WAS NO REPORTED INTERVENTION OR PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9118587 ↗
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- Prestige Coil System PRES0520HPKPLBalt USA LLC · Device, Vascular, For Promoting Embolization2 recalls3 reports
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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