Optima Coil System OPTI3520BLKRecalls & 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 00810068568967), received between May 30, 2025 and May 30, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Premature Separation” (1 report).
1 other recall cover devices cleared under the same FDA submission (K223386); they may or may not involve this specific model.
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.
MalfunctionMay 30, 2025Premature Separation; Premature Separation
IT WAS REPORTED THAT: "VEIN OF GALEN EMBOLIZATION ON INFANT - MULTIPLE OPTIBLOCKS UTILIZED BUT VARIOUS SIZES WEREN'T FORMING DUE TO FLOW. PHYSICIAN PUT THE 3.5X20 ON THE BACK TABLE ALONG WITH OTHER COILS IN THE LOOP. ONCE HE GOT THE FIRST COIL TO FORM, HE PUT THE 3.5X20 BLOCK BACK INTO THE PATIENT AND WENT TO PULL BACK TO REPOSITION AND IT BROKE OFF. THE LOCATION WAS OKAY AND PHYSICIAN JUST PUSHED REMAINING COIL OUT SINCE IT PREMATURELY DETACHED. " INCIDENT REPORT FORM SUBMITTED FOR THIS COMPLAINT INDICATES THAT NO PATIENT INJURY WAS SUSTAINED. ADDITIONAL INFORMATION RECEIVED FROM ISSUER 05MAY2025: "THE ANATOMY WAS FAIRLY TORTUOUS AS IT WAS A HIGH FLOW VEIN OF GALEN AND THE DOCTOR WAS TREATING SPLENIAL 2. HE WAS IN THE SPLENIAL 2 WHICH WAS A PEDACLE OF THE VOGN. HE ADVANCED THE COIL FORWARD AND DIDN'T LOVE THE WAY IT WAS FORMING SO HE PULLED IT BACK AND THAT'S WHEN IT DETACHED. NO ATTEMPTS MADE TO DETACH WITH CONTROLLER. DEVICE WAS IMPLANTED IN PATIENT. NO HARM WAS DONE IT WAS IN THE LOCATION HE WANTED JUST DIDN'T FORM THE WAY HE HAD HOPED."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22118018 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K223386. One submission often covers many models, so check the product and lot details in each record.
- Z-1041-2024 · Jan 3, 2024 · Open, ClassifiedNeurovascular embolization device. The Optima Coil System is a series specialized coils that are inserted into the vasculature under angiographic visualization to embolize intracra
Other Device, Vascular, For Promoting Embolization devices
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- CEREPAKTM MDH1Cerenovus, Inc. · Device, Vascular, for Promoting Embolization1 recall72 reports
- Azur CX Detachable 45-750824Microvention, Inc. · Device, Vascular, for Promoting Embolization115 reports
- Tornado G08261Cook Incorporated · Device, Vascular, for Promoting Embolization2 recalls7 reports
- 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
- Prestige Coil System PRES0520HPKPLBalt 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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