Optima Coil System OPTI0320BLKRecalls & 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
Data updated Oct 13, 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 00810068568950), received between May 16, 2025 and May 16, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Premature Separation” (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. How this data works · Data updated Oct 13, 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 · FDA record ↗
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 16, 2025Premature Separation; Premature Separation
IT WAS REPORTED THAT: "AFTER SUCCESSFUL DEPLOYMENT OF OUR FIRST OPTIBLOCK COIL 5X40 IN A FISTULA PROCEDURE WE BEGIN TO LOAD OUR 2ND COIL 3X20 (F241100216) INTO THE ECHELON CATHETER AND WE WERE MET WITH RESISTANCE. THE PHYSICIAN CONTINUED TO PUSH THE COIL AS WE'RE ALREADY IN THE BODY BUT IT WAS CLEAR THE COIL WOULD NOT ADVANCE AND HAD TRAIN RECKED IN THE MIRCO. WE ENDED UP HAVING TO REMOVE THE ECHELON AND GRAB ANOTHER. AFTER SUCCESSFULLY DEPLOYING 3 MORE COILS WITH THE NEW ECHELON MICRO CATHETER WE TRIED TO PLACE ANOTHER 3X20 (F240801366) COIL. THE PHYSICIAN WAS NOT HAPPY WITH THE PLACEMENT AND TRIED TO REPOSITION THE COIL 3 DIFFERENT TIMES BUT IT WAS CLEAR THE COIL WAS TOO LONG. AS WE WERE TRYING TO RESHEALTH THE COIL THE PHYSICIAN HEARD A POP AND REALIZED THE COIL HAD PREMATURELY DETACHED. WE ENDED UP HAVING TO SNARE THE COIL." INCIDENT REPORT FORM SUBMITTED FOR THIS COMPLAINT INDICATES THAT NO PATIENT INJURY WAS SUSTAINED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22038479 ↗
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
- POD RBYPOD8-APenumbra, Inc. · Device, Vascular, For Promoting Embolization195 reports
- 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
- Prestige Coil System PRES0520HPKPLBalt USA LLC · Device, Vascular, For Promoting Embolization2 recalls3 reports
- Optima Coil System OPTI0413CSFMXBalt 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 13, 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