Optima Coil System OPTI1465BLKRecalls & 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 00840303712619), received between Dec 23, 2025 and Dec 23, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Migration” (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
- Migration1
- 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.
MalfunctionDec 23, 2025Migration; Premature Separation; Migration; Premature Separation
IT WAS REPORTED THAT: "COELIAC VESSEL EMBOLISATION. PREVIOUS STENT IN PLACED IN THE AORTA AND SM. ENDO LEAK WITH POUCH IN COELIAC VESSEL. DR GAINED ACCESS TO THE POUCH WITH A PROGREAT 2FR CATHETER. FIRST COIL LAID DOWN WELL. THE SECOND COIL WAS NOT LAYING OUT WELL, AND THE DR WAS PULLING THE COIL FORWARD AND BACKWARDS AND THE COIL DEPLOYED PREMATURELY. THE OUTCOME WAS HE COULD NOT SNARE THE COIL, AND IT WAS LEFT IN SITU WITH A COIL TAIL. THE CLINICAL OUTCOME WAS THAT THE PATIENT IS FINE, AND THE COIL HAS OCCLUDED THE POUCH EFFECTIVELY. THE PATIENT HAS RECOVERED WELL" UPDATE 24NOV2025 - ADDITIONAL INFORMATION RECEIVED FROM THE ISSUER: "1. DID THE PROCEDURE INVOLVE TORTUOUS ANATOMY? YES 2. WILL THE MICROCATHETER BE AVAILABLE FOR RETURN? NO I DID NOT UPLIFT THIS 3. WHERE DID THE IMPLANT PREMATURELY DETACH? (INSIDE THE AN, INSIDE THE MC?, ETC) INSIDE THE SAC OFF THE OFF THE ENDOLEAK (SEE PICTURE) 4. WERE ANY ATTEMPTS MADE TO DETACH THE IMPLANT COIL USING THE DETACHMENT CONTROLLER? NO 5. CAN YOU CONFIRM IF THE DEVICE WAS IMPLANTED? YES. SEE THE SECOND PICTURE - THE FIRST COIL DEPLOYED IN THE SAC OFF THE ENDOLEAK SUCCESSFULLY - THE SECOND WAS DETACHED PREMATURELY. THE COIL MASS DID STOP
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23877963 ↗
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- Penumbra System RH1-APenumbra, Inc. · DEVICE, NEUROVASCULAR EMBOLIZATION154 reports
- Optima Coil System OPTI0208CSS10Balt USA LLC · Device, Neurovascular Embolization3 recalls3 reports
- POD RBYPOD6-APenumbra, Inc. · DEVICE, NEUROVASCULAR EMBOLIZATION148 reports
- POD RBYPODJ30-APenumbra, Inc. · DEVICE, NEUROVASCULAR EMBOLIZATION132 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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