Optima Coil System OPTI0152CSS10 (REF N/A)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00818053025747), received between Aug 18, 2023 and Dec 19, 2025 — classified as 3 malfunctions.

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

• MalfunctionDec 19, 2025Migration; Premature Separation; Migration; Premature Separation

  IT WAS REPORTED THAT: "THE PHYSICIAN WAS TREATING AN ICA BIFURCATION ANEURYSM. THE PLAN WAS TO DO IT WITH BALLOON ASSISTED COILING. HE TOOK OPTIMA COMPLEX-10 SUPERSOFT 1.5MMX2CM AS LAST COIL. WHILE PUSHING COIL INTO ANEURYSM, COIL WAS PREMATURELY DETACHED AND DEPLOYED, AND ONE LOOP PROLAPSED IN ARTERY, SO HE DECIDED TO DEPLOY LEO STENT TO STABILIZE IT AND FINISHED THE CASE." INCIDENT REPORT FORM SUBMITTED FOR THIS COMPLAINT INDICATES THAT NO PATIENT INJURY WAS SUSTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23853487 ↗
• MalfunctionAug 18, 2023Corroded; Corroded

  IT WAS REPORTED THAT: "<PATIENT INFORMATION> SEX/ AGE: UNKNOWN LOCATION: IC SIZE OF TARGET LESION: 5MM PROCEDURE: EMERGENCY TAE FOR RUPTURED ANEURYSM MICRO CATHETER: SL-10/STRYKER THE OTHER COILS: OPTIMA COILS <DESCRIPTION> WHEN THE PHYSICIAN PERFORMED BEFORE USE CHECK TO CONFIRM WHETHER THE COIL SYSTEM CAN COME OUT FROM TIP OF INTRODUCER SHEATH, THE COIL WON'T ADVANCE. THEN THE PHYSICIAN OPENED ANOTHER OPTIMA AND COMPLETED PROCEDURE. AFTER THE PROCEDURE, THE PHYSICIAN INSPECTED THE COIL SYSTEM AND FOUND FOREIGN SUBSTANCE WITH BROWN COLOR ON THE PUSHER WIRE." INCIDENT REPORT FORM RECEIVED FOR THIS COMPLAINT INDICATED NO PATIENT INJURY WAS SUSTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17573018 ↗
• MalfunctionAug 18, 2023Corroded; Corroded

  IT WAS REPORTED THAT: "<PATIENT INFORMATION> SEX: UNKNOWN DISEASE NAME: UNRUPTURED ANEURYSM(4MM) LOCATION: IC-PC PROCEDURE: PLANNED TAE FOR UNRUPTURED ANEURYSM MICRO CATHETER: HEADWAY/TERUMO THE OTHER COILS: TARGET/STRYKER×4, G3/J&J×3. DESCRIPTION> WHEN THE PHYSICIAN TRIED TO INSERT THE COIL SYSTEM INTO THE MICROCATHETER, THE COIL DID NOT ADVANCE THE INSERTION SHEATH. THEN THE PHYSICIAN CHECKED THE COIL AND FOUND THAT THERE IS SUBSTANCE LIKE RUST ON BETWEEN HYPO TUBE OF PUSHER WIRE AND SHEATH." INCIDENT REPORT FORM RECEIVED FOR THIS COMPLAINT INDICATED NO PATIENT INJURY WAS SUSTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17572829 ↗

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.