Optima Coil System OPTI0204CSSMXRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00818053024993), received between May 29, 2026 and May 29, 2026 — classified as 1 malfunction.

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

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

4 other recalls cover devices cleared under the same FDA submission (K200030); 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 29, 2026Migration

  IT WAS REPORTED THAT: "THE PHYSICIAN WAS TREATING A RUPTURED RIGHT PCOM ANEURYSM. SHE WAS ABLE TO SUCCESSFULLY DEPLOY A 4X7 OPTIMAX. SHE FOLLOWED WITH A 2X4 OPTIMAX. SHE WAS ABLE TO POSITION THE COIL AFTER ATTEMPTING MULTIPLE ADJUSTMENTS PULLING/PUSHING TO FIND THE RIGHT PLACEMENT. SHE RECEIVED A SUCCESSFUL GREEN LIGHT SEQUENCE ON THE DETACHER. SHE SLOWLY PULLED BACK THE PUSHER WIRE FROM THE COIL MASS UNTIL THE WIRE WAS NO LONGER VISIBLE ON THE SCREEN WHEN THE TAIL OF THE COIL GOT SUCKED INTO THE MICROCATHETER. SHE USED THE PUSHER WIRE TO REPOSITION THE COIL AND TUCK IT BACK INTO THE MASS THEN STARTED PULLING BACK ONCE AGAIN. AGAIN, THE PUSHER WIRE WAS OFF THE SCREEN WHEN THE COIL SUCKED BACK INTO THE MICRO. SHE THEN ADVANCED THE MICRO AND GUIDEWIRE AT THE SAME TIME WHICH FREED THE COIL; HOWEVER, IT DISPLACED THE LAST LOOP AND IT MOVED INTO THE ICA. SHE TRIED ONCE AGAIN TO PUSH THE TAIL BACK INTO THE COIL MASS USING THE GUIDEWIRE AND MICRO WHICH ENDED UP FURTHER KICKING THE TAIL INTO THE ICA. SHE WAS WORRIED ABOUT THE COIL FLYING AWAY AND DECIDED TO STENT DOWN THE COIL TAIL. NO FURTHER COILS WERE DEPLOYED. SHE USED A 45 DEGREE SL10 AS THE MICRO." UPDATE 01MAY2026 - ADDITIONAL INFOR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25333034 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K200030. 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.
• Z-0660-2022 · Jan 4, 2022 · Open, Classified
  The Optima Coil System consists of an implantable embolization coil comprised of a platinum-tungsten alloy attached to a proximal stainless steel hypo-tube and distal body coil del