Optima Coil System OPTI0650BLK (REF N/A)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00810068568769), received between Oct 12, 2023 and Oct 12, 2023 — classified as 1 malfunction.

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

1 other recall cover devices cleared under the same FDA submission (K223386); 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 16, 2026.

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.

• MalfunctionOct 12, 2023Premature Separation; Premature Separation

  IT WAS REPORTED THAT: "DURING THE COIL EMBOLIZATION OF A BILATERAL CCF THE PHYSICIAN'S HAD A PREMATURE DETACHMENT OF AN OPTIBLOCK 6MM X 50CM. PHYSICIAN'S GAINED ACCESS OUT THE LEFT CAVERNOUS SINUS WITH A HEADWAY .021 MICROCATHETER. THEY HAD DEPOLOYED 9 OPTIBLOCK SUCCESSFULLY INTO THE CAROTID / CAVERNOUS CONNECTION. AFTER THE SUCCESSFUL TRANSFER OUT OF THE SHEATH AND INTO THE .021 MICROCATH, THEY BEGAN DEPLOYING THE 6 X 50 BLOCK INTO THE CCF. AFTER ABOUT 30CMS DEPLOYED, SIGNIFICANT RESISTANCE WAS FELT AND THE COIL WOULD NOT ADVANCE FURTHER. THEY REPOSITIONED THE MICROCATHETER AND COIL TO TRY AND OPEN UP SOME SPACE FOR THE REMAINING 20CMS. UPON REPOSITIONING OF THE BLOCK THE PUSHER BECAME DETACHED FROM THE COIL. THEY REMOVED THE PUSHER WITH THE REMAINING COIL STILL IN THE MICROCATHETER. THEY TOOK UP AN .016 COIL PUSHER AND WITH MINOR RESISTANCE SUCCESSFULLY DEPLOYED THE REMAINING 20CMS OF COIL. PHYSICIAN'S CONTINUED TO DEPLOY AN ADDITIONAL 4 OPTIBLOCK WITHOUT ISSUE." INCIDENT REPORT FORM SUBMITTED FOR THIS COMPLAINT INDICATES THAT NO PATIENT INJURY WAS SUSTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17927848 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K223386. One submission often covers many models, so check the product and lot details in each record.

• Z-1041-2024 · Jan 3, 2024 · Open, Classified
  Neurovascular embolization device. The Optima Coil System is a series specialized coils that are inserted into the vasculature under angiographic visualization to embolize intracra