Optima Coil System OPTI0103BLKRecalls & 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
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00810068568851), received between Aug 18, 2025 and Aug 18, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Migration” (1 report).
1 FDA recall record name this device's identifier, 1 still open.
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
Recalls naming this device
- May 8, 2025Open, Classified
Due to radiopaque (RO) marker was not visible during angiography and it was determined that the RO marker was not manufactured to specification.
Z-1988-2025 · Root cause: Vendor change control · Recall details · FDA record ↗
Most reported problems
Device problems
- Migration1
- Separation Failure1
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 18, 2025Separation Failure; Migration; Separation Failure; Migration
IT WAS REPORTED THAT: "THE PHYSICIAN WAS TREATING AN AVM THAT WAS BEING FED FROM THE LEFT MMA. WE HAD ALREADY DEPLOYED TWO OPTIBLOCK MINI COILS WITH NO ISSUES AND WERE HOPING TO FINISH THE CASE WITH AN OPTIBLOCK. WE WERE IN THE POSTERIOR BRANCH OF THE MMA AND THE PHYSICIAN WANTED TO DEPLOY THE OPTIBLOCK 1X3 VERY DISTAL. WHEN GOING TO DETACH THE COIL, HE SAW DAYLIGHT AND HAD FORWARD PRESSURE ON THE COIL. HE TESTED THE COIL IN THE DETACHER AND GOT A SOLID GREEN, THEN WENT THROUGH ALL NORMAL COILING AND DETACHMENT PROCEDURE. AFTER PRESSING THE BUTTON AND GETTING THE SOUND OF A GOOD DETACHMENT, HE PULLED BACK ON THE PUSHER AND THOUGHT THE COIL WAS DETACHED. AFTER PULLING BACK ABOUT 1CM, HE REALIZED IT WAS INDEED NOT DETACHED. HE TRIED TO ADVANCE HIS PUSHER WIRE AND MICROCATHETER, THERE WAS CLEAR GAP BETWEEN PUSHER AND COIL. HE THEN PULLED BACK ON HIS MICRO AND NOTICED THAT HE WAS PULLING BACK COIL MASS AS WELL WITH HIS MICRO. HE ADVANCED HIS TRAXCESS WIRE TO CLEAR THE TIP OF THE MICRO AND PUSHED THE REMAINING COIL MASS BACK. THE COIL MASS HAD STILL MIGRATED ABOUT 4CM BACK BUT WAS STILL IN A CLINICALLY SAFE LOCATION. THERE WAS NO PATIENT INJURY INVOLVED, AND WE CONCLUDED THE CASE." INCI
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22828395 ↗
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
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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 · each recall links to the FDA recall notice
- 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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