Optima Coil System OPTI0306CSS10 (REF N/A)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00818053025884), received between Aug 18, 2023 and Jan 24, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Contamination /Decontamination Problem” (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. 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.

• MalfunctionJan 24, 2025Migration; Migration

  IT WAS REPORTED THAT: "THE PHYSICIAN WAS TREATING A PCOM ANEURYSM CASE. AFTER SUCCESSFULLY DEPLOYING FEW COILS FROM HEADWAY 17,. HE TOOK THIS 3*6 OPTIMA COIL AND PLACE IT INSIDE THE Y CONNECTOR AND WAITED FOR SALINE TO COME OUT OF THE SHEATH, ONCE THE DROPLETS COME OUT FROM THE SHEATH, THEN HE START DEPLOYING THE COIL INSIDE THE ANEURYSM AND AFTER SUCCEFUL DEPLOYMENT HE DETACHED THE COIL AD REMOVE THE PUSHER WIRE FROM THE MICRO CATHETER AND TOOK A FLOURO RUN THAT TIME HE FOUNDS THERE IS SOMETHING LYING NEAR THE NECK OF THE ANEURYSM AFTER TAKING FEW MORE SHOTS HE REALIZED THAT IT IS THE PART OF THE DETACHED PUSHER WIRE THEN HE HAD TO DEPLOY A STENT OVER IT AND COMPLETED 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 21230679 ↗
• MalfunctionNov 2, 2023Contamination /Decontamination Problem; Insufficient Device Problem Information; Contamination /Decontamination Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT: "<PATIENT INFORMATION> SEX: UNKNOWN. DISEASE NAME: AN. PROCEDURE: PLANED TAE. MICRO CATHETER: UNKNOWN. USED COILS: UNKNOWN. <DESCRIPTION> WHEN THE PHYSICIAN REMOVED PACKAGE OF OPTIMA AND TRIED TO ADVANCED IMPLANT COIL AS BEFORE USE CHECK, THE PHYSICIAN FOUND BROWN SUBSTANCE IN THE LUMEN OF INTRODUCER SHEATH AND THE COIL WOULD NOT ADVANCE. THEN THE PHYSICIAN OPENED NEW OPTIMA WITH SAME SIZE TO COMPLETE PROCEDURE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18056174 ↗
• MalfunctionAug 18, 2023Poor Visibility; Poor Visibility

  IT WAS REPORTED THAT: PROCEDURE: EMERGENCY TAE FOR AN MICRO CATHETER: SL10/STRYKER OTHER COILS: TARGET/STRYKER, OPTIMA 3×8. <DESCRIPTION> AFTER PLACING OPTIMA 3×8, THE PHYSICIAN ADVANCED COIL INTO MICRO CATHETER. HE INSISTS THAT HE THINKS THE POSITION OF FLUOR MARKER WAS NOT CORRECT (IT WAS DISPLACED TO THE PROXIMAL SIDE.) SINCE WHEN HE STARTED FLUOROSCOPY OF TARGET LESION, HE FOUND THAT THE IMPLANT COIL HAD ALREADY ENTERED THE ANEURYSM DESPITE HE STOPPED ADVANCEMENT AT THE POINT OF THE FLUOR MARKER REACHED Y CONNECTOR. THE PROCEDURE WAS COMPLETED EXCHANGING TO ANOTHER OPTIMA OF SAME SIZE." INCIDENT REPORT FORM RECEIVED FOR THIS COMPLAINT INDICATED NO PATIENT INJURY WAS SUSTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17573028 ↗

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.