Optima Coil System OPTI0517CSF10 (REF N/A)Recalls & reported problems
Balt USA LLC · The Optima Coil System is indicated for endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations (AVMs) and arteriovenous fistulae. The Optima Coil System is also indicated for vascular occlusion of blood vessels within the neurovascular system to permanently obstruct blood flow to an aneurysm or other vascular malformation and for arterial and venous embolization in the peripheral vasculature. The Optima Coil System comprises of implant coil and a pusher assembly. The Optima Coil System is designed fr use with the XCEL Detachment Controller. The Optima coil is detached thermally with the XCEL Detachment Controller. · Class 2 · Implant
All models of Optima Coil System (379)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
2 open recalls name 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
- 2
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00818053026157), received between May 8, 2024 and May 8, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Inaccurate Information” (1 report).
2 FDA recall records name this device's identifier, 2 still open.
2 other recalls cover devices cleared under the same FDA submission (K172390); 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 ↗
- Jan 3, 2024Open, Classified
Discoloration was identified along the delivery pusher which was attributed to corrosion of the hypotube. The material which caused the corrosion was identified as remnants of solder flux residue remaining on the hypotube component of the delivery pusher. Due to the location of the delivery pusher within the delivery system, it is possible for the discoloration to mechanically break off from the delivery pusher, leaving the potential for the material to flow through the delivery system (i.e. microcatheter), and into the patient vasculature causing foreign emboli.
Z-1041-2024 · Root cause: Material/Component Contamination · Recall details · FDA record ↗
Most reported problems
Device problems
- Inaccurate Information1
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 8, 2024Inaccurate Information; Inaccurate Information
IT WAS OBSERVED DURING THE RETURN PROCESS THAT A UNIT FROM OPTIMA COIL FINAL ASSEMBLY PRODUCT OPTI0517CSF10, LOT F230100270 HAD THE INCORRECT EXPIRATION DATE PRINTED ON THE CARTON LABEL, HOWEVER THE POUCH LABEL WAS CORRECT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19274336 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K172390. One submission often covers many models, so check the product and lot details in each record.
- Z-0103-2023 · Sep 7, 2022 · Open, ClassifiedOptima Coil System Model Number OPTI0208CSS10, Model Number OPTI0308CSS10. Used in endovascular procedures.
- Z-1680-2022 · Jul 26, 2022 · Open, ClassifiedOptima Coil System Model OPTI0520CSF10. For endovascular embolization.
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 · 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.
How reports and recalls are matched · Editorial policy · Report an error on this page