Optima Coil System OPTI0724CSF10 (REF N/A)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00818053026218), received between Nov 17, 2023 and Nov 17, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Expulsion” (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.

• MalfunctionNov 17, 2023Expulsion; Expulsion

  IT WAS REPORTED THAT: "RUPTURED ACOM LOBULATED ANEURYSM WAS COILED, MICROCATHETER VASCO+10 WAS USED, FIRSTLY THE SMALL DOUGHTER SAC WAS COILED WITH SUPERSOFT COIL 4*6 MM AND THE MICROCATHETER WASS PULLED BACK TO THE MAIN SAC OF THE ANEURYSM, FIRST FRAIMING COIL AND SECOND FILING COILS WERE INSERTED UNEVENTUALLY WITH ONE REPOSITIONING MANEUVER OF THE SECOND COIL DUE TO LOOP PROTRUSION, THEN THE THIRD COIL COMPLEX-10 SOFT 7MM *24 CM WAS INSERTED SMOOTHLY AND DUE TO COIL PROTRUSION TO THE PARENT ARTERY RIGHT ACA AFTER INSERTING 2/3 OF THE COIL AN EFFORT MADE TO REPOSITION THE COIL, AFTER PULLING ABOUT ONE CENTIMETER OF THE COIL, THE COIL DETACHED IN THE MICROCATHETER, FORTUNATLY I WAS ABLE TO PUSH IT BACK TOTALLY WITH THE COIL PUSHER IN TO THE ANEURYSM SAC WITH NO PROTRUSION. THE MICROCATHETER REMOVED FROM THE ANEURYSM SMOOTHLY." INCIDENT REPORT FORM SUBMITTED FOR THIS COMPLAINT INDICATES THAT NO PATIENT INJURY WAS SUSTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18165445 ↗

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.