Optima Coil System OPTI1265BLKRecalls & 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 00810068568844), received between Jan 31, 2024 and Jan 31, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Migration” (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
- 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.
MalfunctionJan 31, 2024Migration; Premature Separation; Migration; Premature Separation
IT WAS REPORTED THAT: "PHYSICIAN WAS ADVANCING COIL INTO A FISTUAL POUCH. THE COIL PREMATURELY DETACHED. THERE WAS AN EXTREMELY LONG TAIL (APPROXIMATELY 15-20CM) OF COIL STILL LEFT IN THE MMA. PHYSICIAN HAD TO PULL OUT THE MICROCATHETER, ACCESS THE FISTULA ALONGSIDE THE DETACHED COIL TO CONTINUE. WE WERE ABLE TO FINISH THE CASE. UNABLE TO SEND BACK PUSHER AS WAS DESTROYED AND TRASHED BEFORE I COULD GRAB IT." INCIDENT REPORT FORM SUBMITTED FOR THIS COMPLAINT INDICATES THAT NO PATIENT INJURY WAS SUSTAINED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18617193 ↗
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, 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 16, 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