Optima Coil System OPTI0923CST10 (REF N/A)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00818053026379), received between Aug 27, 2025 and Aug 27, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Failure to Advance” (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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. 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 ↗

2. 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 · FDA record ↗

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 27, 2025Failure to Advance; Premature Separation; Failure to Advance; Premature Separation

  IT WAS REPORTED THAT: "WHEN POSITIONING THE FIRST MICROCOIL IN THE ANEURYSM, THE DOCTOR NOTICED A FAILURE IN THE COIL'S NAVIGATION, EVIDENCING PREMATURE DETACHMENT. THE ENTIRE ACCESS SYSTEM WITH THE COIL WAS REMOVED BECAUSE FORTUNATELY MOST OF IT WAS STILL IN THE MICROCATHETER. A NEW ACCESS WAS MADE AND NEW COILS WERE USED WITHOUT INTERFERENCE." INCIDENT REPORT FORM SUBMITTED FOR THIS COMPLAINT INDICATES THAT NO PATIENT INJURY WAS SUSTAINED. UPDATE 28JUL2025- ADDITIONAL INFORMATION RECEIVED FROM THE ISSUER: . DID THE PROCEDURE INVOLVE TORTUOUS ANATOMY? YES. TORTUOUS ANATOMY. ATTACHED ARE IMAGES OF THE SURGERY. 2. WILL THE MICROCATHETER BE AVAILABLE FOR RETURN? NO. THE MICROCATHETER WAS DISCARDED ALONG WITH THE OTHER MATERIALS. 3. WHERE DID THE IMPLANT PREMATURELY DETACH? (INSIDE THE AN, INSIDE THE MC?, ETC) THE DETACHMENT OCCURRED WITHIN THE MICROCATHETER, BUT PART OF THE MICROCOIL WAS ALREADY POSITIONED IN THE ANEURYSM. THE DETACHMENT OCCURRED DURING COIL POSITIONING. 4. WERE ANY ATTEMPTS MADE TO DETACH THE IMPLANT COIL USING THE DETACHMENT CONTROLLER? NO. NO ATTEMPT, BECAUSE WHEN THE SPRING DETACHED FROM THE DELIVERY WIRE IT WAS NO LONGER NECESSARY TO DETACH IT. 5. CAN YOU CONFIR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22906102 ↗

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, Classified
  Optima Coil System Model Number OPTI0208CSS10, Model Number OPTI0308CSS10. Used in endovascular procedures.
• Z-1680-2022 · Jul 26, 2022 · Open, Classified
  Optima Coil System Model OPTI0520CSF10. For endovascular embolization.