Optima Coil System OPTI0206CSS10 (REF N/A)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00818053025808), received between Apr 26, 2023 and Apr 18, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Fracture” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 18, 2025Migration; Premature Separation; Migration; Premature Separation

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21869279 ↗
• MalfunctionApr 26, 2023Fracture; Fracture

  IT WAS REPORTED THAT: "THE XCEL BLINKED GREEN AND REG LIGHT IN THE BEGINNING, BUT TRYING AGAIN IT WORKED AND THE PROCEDURE WAS STARTED. AFTER INSERTION INTO THE ANEURYSM DETACH WAS TRIED BUT NO SOUND WAS DETECTED AND DID NOT DETACH. OTHER METHODS SUCH AS CHANGING THE XCEL WAS TRIED BUT DID NOT WORK, THEREFORE THE IMPLANT WAS TAKEN OUT AND CUT BY FORCE." 30MAR2023, ADDITIONAL INFORMATION RECEIVED BY THE ISSUER: "WE WERE TOLD THE IMPLANT FAILED TO DETACH, AND WAS REMOVED FROM THE ANEURYSM AND THE STRETCHED PART OF THE COIL WAS CUT WITH A SNARE. IT IS ASSUMED A PART OF THE COIL WAS REMOVED AND A PART REMAINED IN THE BODY." 04APR2023, ADDITIONAL INFORMATION RECEIVED BY THE ISSUER: "THE COIL WAS CAUGHT DURING REMOVAL, AND SNARE WAS USED TO REMOVE BY HOOKING BUT IT WAS STRETCHED AND CUT AND THROWN AWAY, THEREFORE IT IS DIFFICULT TO CHECK. WHEN REMOVING THE COIL FROM THE CATHETER FROM PULLING THE PUSHER, IT WAS CAUGHT AND COULD NOT BE REMOVED, THEREFORE A SNARE WAS USED. THE USER WAS ABLE TO CONFIRM THE TOTALITY OF THE IMPLANT COIL WAS CAPTURED WITHIN THE MICROCATHETER THROUGH THE RADIOPAQUE MARKER IN THE VIDEO (THE USER IS EXPERIENCED WITH THE USE OF THE DEVICE). THE SNARE STRETCHED THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16818254 ↗

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.