Optima Coil System OPTI0435BLK (REF N/A)Recalls & 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 16, 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 00840303712480), received between Mar 11, 2026 and Mar 11, 2026 — classified as 1 malfunction.
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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Premature Separation1
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.
MalfunctionMar 11, 2026Premature Separation
IT WAS REPORTED THAT: "THE PHYSICIAN WAS TREATING A DURAL AVF WITH OPTIBLOCK COILS. WE HAD SUCCESSFULLY DELIVERED (10) OPTIBLOCKS PRIOR TO ISSUE. ON THE 11TH COIL, WE WERE ATTEMPTING TO USE A 4MMX35CM OPTIBLOCK. WE HAD TO ADUST THE COIL POSITION SEVERAL TIMES AS WE COULD NOT GET THE COIL TO SIT EXACTLY WHERE WE WANTED. AFTER MULTIPLE REPOSITIONS, THE COIL PREMATURELY DETATCHED AND WE HAD TO REMOVE THE ENTIRE COIL. THERE WAS NOT A LOT OF VESSEL TOURTOSITY AND THE ONLY THING TO NOTE WOULD BE THE HANDFUL OF TIMES WE HAD TO REPOSITION THE COIL." INCIDENT REPORT FORM SUBMITTED FOR THIS COMPLAINT INDICATES THAT NO PATIENT INJURY WAS SUSTAINED. UPDATE 27FEB2026 - ADDITIONAL INFORMATION RECEIVED FROM THE ISSUER: "COIL WAS AT TREATMENT LOCATION WHEN THIS OCCURRED. THE PHYSICIAN USED A 3CC SYRINGE ON THE BACK OF THE MICRO TO SUCTION BACK COIL UNTIL HE GOT THE COIL ALL INTO MICRO THEN REMOVED THE MICRO CATHETER."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24570775 ↗
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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
- Optima Coil System OPTI0413CSFMXBalt 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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