Optima Coil System OPTI0930CST10 (REF N/A)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00818053026386), received between Nov 3, 2020 and Nov 3, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Jan 3, 2024Class IIOpen, 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

Recent adverse event reports

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

• MalfunctionNov 3, 2020Break; Separation Failure; Physical Resistance/Sticking

  IT WAS REPORTED: "THE PHYSICIAN WAS DOING A VENOUS EMBO OF A DAVF WHERE HE WAS COILING OFF THE TRANSVERSE SINUS. HIS 37TH COIL WAS A 9X30 COMPLEX STANDARD. THE CATHETER HAD LOTS OF FORWARD TENSION AND HE WAS PACKING IN A TIGHT SPOT. HE ATTEMPTED TO DETACH AND THE COIL DIDN'T RELEASE AFTER FIRST CYCLE. HE TRIED A SECOND CYCLE AND XCEL WAS GIVING CHRISTMAS TREE LIGHTS AND THE COIL DIDN'T DETACH. HE TRIED A THIRD TIME AND PUSHED THE COIL AND PUSHER WELL PAST THE PROXIMAL LINE AND IT STILL DIDN'T POP OFF THE PUSHER. HE TRIED DETACHING A FOURTH TIME. HE THEN TRIED TO REMOVE THE COIL AND IT WAS LODGED IN THE COIL MASS. HE PULLED UNTIL THE COIL BROKE AND SEPARTED. THE COIL AND PUSHER STRETCHED AS HE REMOVED. HE THEN HAD TO REMOVE THE CATHETER AND THERE WAS COIL AND PUSHER STRETCHED OUT OF THE SHEATH. HE PULLED AND BROKE OFF MORE OF THE COIL AND PUSHER. HE HAD TO REMOVE THE SHEATH BECAUSE THERE WAS COIL AND PUSHER DOWN THE SHEATH. HE PULLED ANOTHER SEGMENT OF COIL OUT UNTIL IT BROKE. HE PLACED ANOTHER SHEATH AND CATHETER AND WAS ABLE TO FINISH THE CASE WITHOUT HARM TO THE PATIENT. HE USED 10 MORE OPTIMAS WITHOUT ANY INCIDENT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10778881 ↗

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.