Optima Coil System OPTI0212BLKTRecalls & reported problems
Balt USA LLC · The Optima Coil System is a series of specialized coils that are inserted into the vasculature under angiographic visualization to embolize intracranial aneurysms and other vascular anomalies. The system consists of an embolization coil implant comprised of platinum and tungsten, affixed to a delivery pusher to facilitate insertion into the hub of a microcatheter. The system is available in various shapes, lengths, and sizes. The devices are to be placed into aneurysms to create blood stasis, reducing flow into the aneurysm and thrombosing the aneurysm. Upon positioning coils into the aneurysm, the coils are detached from the delivery pusher in a serial manner until the aneurysm is occluded · Class 2 · Implant
All models of Optima Coil System (379)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00840303711995), received between Aug 15, 2025 and Aug 15, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Separation Problem” (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
- 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.
MalfunctionAug 15, 2025Separation Problem; Separation Problem
IT WAS REPORTED THAT: "PHYSICIAN WAS PERFORMOING AN MMA EMBOLIZATION. HE REQUESTED THE 2X12 MINI. HE PLACED THE 2X12 AND WENT TO DETACH. HE WAS GIVEN A GREEN LIGHT AND PRESSED THE BUTTON TO DETACH. UPON PULLING BACK NOTICED IT WAS NOT DETACHED. HE TRIED 4 MORE TIMES; IT GAVE THE GREEN LIGHT EVERY TIME AND MADE AUDIBLE NOISE OF A SUCCESSFUL DETACH BUT WOULD NOT DETACH. HE THEN PULLED THE COIL TO REPLACE IT WITH ANOTHER. HE PULLED THE COIL OUT SLOWLY AND SMOOTHLY AS WAS COACHED. THE COIL ENTERED THE SL-10 3/4 OF THE WAY AND THEN DETACHED FROM THE PUSHER WIRE. WE WERE UNABLE TO ADVANCE THE WIRE TO PUSH OUT THE COIL. WE HAD TO REMOVE THE SL-10 BACK INTO THE VECTA 46 THEN PUSH THE COIL OUT OF THE VECTA 46 WITH AN 035 WIRE." INCIDENT REPORT FORM SUBMITTED FOR THIS COMPLAINT INDICATES THAT NO PATIENT INJURY WAS SUSTAINED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22821854 ↗
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- 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.
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