Optima Coil System OPTI0330BLKRecalls & 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
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00840303711889), received between May 29, 2026 and Jun 12, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Premature Separation” (2 reports).
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 Separation2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 12, 2026Premature Separation
IT WAS REPORTED THAT: "PHYSICIAN WAS COILING THE HOLE OF A CC FISTULA AND WENT UP WITH A OPTIBLOCK 3X30 DURING DEPLOYMENT THE PHYSICIAN WENT TO REPOSITION HIS MICROCATHETER SO HE PULLED THE COIL BACK AS IT WAS STILL BEING DEPLOYED AND THEN THE COIL SNAPPED INSIDE THE MICROCATHETER WITH SOME OF IT LEFT IN THE FISTULA HOLE. THEY WERE ABLE TO USE A BALLOON AS A SNARE TO TRAP THE LOOSE COIL AGAINST THE SIDE OF THE MICROCATHETER AND REMOVE IT FROM THE PATIENT VESSEL." INCIDENT REPORT FORM SUBMITTED FOR THIS COMPLAINT INDICATES THAT NO PATIENT INJURY WAS SUSTAINED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25488954 ↗MalfunctionMay 29, 2026Premature Separation
IT WAS REPORTED THAT: "THE PHYSICIAN WAS TREATING A BILATERAL MMA. SHE WAS COILING PROXIMALLY AND WAS DEPLOYING A 3X30 OPTIBLOCK. SHE DIDN'T LIKE THE WAY IT WAS TRACKING SO SHE GENTLY PULLED BACK ON THE COIL AND IT BROKE. SHE USED A 3MM TREEVO TO CAPTURE THE COIL AND PROCEEDED WITH THE PROCEDURE. I HAD PLANNED ON RETURNING THE COIL BUT THE STAFF THREW IT AWAY WHILE I WAS GRABBING ADDITIONAL COILS FOR THE CASE." INCIDENT REPORT FORM SUBMITTED FOR THIS COMPLAINT INDICATES THAT NO PATIENT INJURY WAS SUSTAINED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25332944 ↗
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- 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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