Optima Coil System OPTI0408CSS10 (REF N/A)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00818053025945), received between Jan 25, 2022 and Jul 30, 2024 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Premature Separation” (2 reports).

1 FDA recall record name this device's identifier, 1 still open.

3 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. 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 30, 2024Migration; Difficult or Delayed Separation; Migration; Difficult or Delayed Separation

  IT WAS REPORTED THAT: "A 48 YEARS OLD WOMAN WAS ADMITTED TO OUR CENTER TO EMBOLIZE A LEFT PARAOPTHLAMIC ANEURYSM WITH COILS. AFTER THE DEPLOYMENT OF THE FIRST FRAMING COIL (NON-OPTIMA COIL), A SECOND COIL (OPTIMA COMPLEX-10 SUPERSOFT 4X8 CM) WAS NAVIGATE INSIDE THE ANEURYSM WITH NO DIFFICULTIES. DESPITE OF THAT, WE COULD NOT DEPLOY THE COIL AFTER SEVERAL ATTEMPTS. AT THIS POINT, WE DECIDED TO REMOVE THE COIL, BUT AFTER REMOVE THE FIRST MM OF IT, THE WIRE WAS BROKEN AND THE COIL REMAINED RELEASED WITH A PART OUTSIDE THE ANEURYSM. THEREFORE, WE NAVIGATED A 0.014" MICROWIRE THROUGH THE MICROBALLOON TO TRY TO PACK THE COIL INSIDE THE ANEURYSM. HOWEVER, WE REALIZED THAT THE COIL STARTED TO MOVE BEFORE THE MICROWIRE ACHIEVE THE COIL, SO WE INTERPRETED THAT ACTUALLY THE COIL WAS BROKEN NOT IN THE INTERSECTION BETWEEN THE COIL AND THE WIRE, BUT RATHER SOME POINT ALONG THE WIRE OF THE COIL. FINALLY, WE ACHIEVED A COMPLETE OCCLUSION OF THE ANEURYSM WITH AN OPEN-CELL STENT AND 6 MORE COILS. THE PATIENT WOKE ASYMPTOMATIC WITH A MODERATE MIGRAINE AND SHE LEFT THE HOSPITAL 48 HOURS LATER WITHOUT NO OTHER INCIDENCES." UPDATE 10JUL2024 - ADDITIONAL INFORMATION RECEIVED FROM THE ISSUER: "1. DID THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19862855 ↗
• MalfunctionJan 5, 2023Premature Separation; Premature Separation

  IT WAS REPORTED THAT: "INDEED, THERE WAS AN UNCONTROLLED DETACHMENT (THE EQUIPMENT WAS RELEASED WITHOUT THE PLANNED DETACHMENT SYSTEM: BY THE ELECTRIC DETACHER). THE MATERIAL WAS THEREFORE FOUND INTRACRANIAL IN THE CEREBRAL ARTERIAL FLOW." 13DEC2022, ADDITIONAL INFORMATION PROVIDED BY ISSUER - TRANSLATION FRENCH TO ENGLISH: "- COULD YOU TELL US IF THIS INCIDENT WAS NOTIFIED TO THE ANSM? : YES. - COULD YOU TELL US HOW THE DOCTOR COMPLETED THE PROCEDURE? (USE OF A NEW COIL): THE DOCTOR RESORTED TO EMERGENCY ASPIRATION THROUGH A THROMBECTOMY CATHETER (SOFIA 6F) TO RETRIEVE THE COIL. - COULD YOU TELL US IF THE DOCTOR CARRIED OUT AN ADDITIONAL INTERVENTION? : THE DOCTOR HAS STOPPED THE INTERVENTION. ISSUER CONFIRMED NO PATIENT INJURY WAS SUSTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16103368 ↗
• MalfunctionJan 25, 2022Premature Separation; Premature Separation

  IT WAS REPORTED THAT: "AFTER USING IT AS THE FIRST FRAME, THE BASKET COULD NOT BE FORMED WELL, SO WHEN REMOVING THE COIL, THE COIL DID NOT MOVE. WHEN CHECKED IT WAS FOUND THAT IT WAS PRE-DETACHED. THE PROFESSOR WAS FLUSTERED BECAUSE IT BROKE EASILY AFTER PUSHING IT IN AND OUT ONLY ONCE OR TWICE. FORTUNATELY, THE COIL WAS RETRIEVED BY SNARE AND RECOVERED, BUT PUSHER COULD NOT BE RECOVERED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13345107 ↗

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-1988-2025 · May 8, 2025 · Open, Classified
  Optima Coil System REFs/UDI-DI codes: OPTI0156BLK 00810068568875 OPTI0158BLK 00810068568882 OPTI0103BLK 00810068568851 OPTI0258BLK 00810068568929 OPTI0212BLK 00810068568912 OPTI020
• 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.