Optima Coil System OPTI0427BLKRecalls & 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 00840303711902), received between Jun 18, 2025 and Jun 18, 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 18, 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.
MalfunctionJun 18, 2025Migration; Premature Separation; Migration; Premature Separation
IT WAS REPORTED THAT: "THE PHYSICIAN WAS TREATING A VOGN ON A 3 DAY OLD PATIENT. HE GOT COMMON FEMORAL ARTERY ACCESS AND USED STANDARD TECHNIQUES TO REACH THE VOGN JUNCTION. USING A HEADWAY DUO, THE PHYSICIAN ATTEMPTED TO DEPLOY AN OPTIBLOCK 4X27 WHICH WOULD NOT SIT AT THE JUNCTION. DUE TO THE HIGH FLOW, THE COIL WAS GOING INTO THE MALFORMATION. THE PHYSICIAN FELT THE 4X27 COIL WAS TOO SMALL AND CHOSE TO REMOVE THE COIL AND INPUT A 5X40 OPTIBLOCK. THE 5X40 WAS NOT SITTING AT THE JUNCTION EITHER AND APPEARED TO BE TOO SMALL WHICH WAS CAUSING IT TO GO INTO THE MALFORMATION. THE 5X40 COILED INSIDE THE CATHETER AND STRETCHED SO THEY DECIDED TO USE IT FOR RESEARCH TO OBTAIN CELLS FROM THE MALFORMATION. UPON COMPLETION OF COLLECTING CELLS, THE PHYSICIAN GRABBED THE 4X27 OPTIBLOCK FROM THE BACK TABLE AND TRIED TO RE-DEPLOY IT IN THE SAME LOCATION. FLOW WAS EXTREMELY HIGH AND THE COIL KEPT PROLAPSING INTO THE MAIN MALFORMATION SO HE PULLED BACK SLIGHTLY AND THE COIL WENT INTO A FEEDER. THREE LOOPS FORMED IN THE FEEDER AND THE PHYSICIAN CALLED OUT THAT THE COIL WAS "STUCK." UPON TRYING TO REMOVE THE COIL FROM THE SEGMENT IT WAS STUCK IN, THE COIL DETACHED AND THE "TAIL" OF THE COIL EXTENDED
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22286693 ↗
Other Device, Neurovascular Embolization devices
- POD RBYPODJ60-APenumbra, Inc. · DEVICE, NEUROVASCULAR EMBOLIZATION355 reports
- Penumbra System SCH1Penumbra, Inc. · DEVICE, NEUROVASCULAR EMBOLIZATION295 reports
- RUBY Coil RBY4C0860-APenumbra, Inc. · DEVICE, NEUROVASCULAR EMBOLIZATION276 reports
- Smart Coil 400SMTHXSFT0208Penumbra, Inc. · DEVICE, NEUROVASCULAR EMBOLIZATION165 reports
- 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page