Optima Coil System OPTI0208HSS10 (REF N/A)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00818053026706), received between Jul 20, 2023 and Jul 20, 2023 — classified as 1 malfunction.

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

2 FDA recall records name this device's identifier, 2 still open.

2 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 16, 2026.

Recalls naming this device

1. May 8, 2025Open, Classified

   Due to radiopaque (RO) marker was not visible during angiography and it was determined that the RO marker was not manufactured to specification.

   Z-1988-2025 · Root cause: Vendor change control · Recall details · FDA record ↗

2. 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 · 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.

• MalfunctionJul 20, 2023Premature Separation; Premature Separation

  IT WAS REPORTED THAT: "IT WAS A CASE OF ACOM ANEURYSM MEASURING 5.7MM*5MM WITH NECK OF 2 MM THE PHYSICAN PLANNED TO DO SIMPLE COILING. THE SUPPORT SYSTEM WAS VISTA BRITE 90CM AND FARGOMAX, THE VASCO10D WAS PLACED INSIDE THE ANEURYSM WITH SUPPORT OF HYBRID1214D. THE VASCO10D WAS CONNECTED WITH A FLUSH LINE. THE COIL WAS PREPARED AS PER IFU AND THEN ALIGNED TO THE HUB OF THE MICRO CATHETER, THE FIRST COIL SIZE OF 5MM*13MM OPTIMA COMPLEX10 WAS TAKEN ON INTRODUZING, THE COIL WENT SMOOTHLY THROUGH THE SLEEVE INTO THE HUB OF VASCO10 AND DETACHED LATER TOOK 4MM*13MM OPTIMA COMPLEX10 AND DETACHED NEXT PHYSICIAN TOOK 2MM*8MM OPTIMA HELICAL SUPERSOFT THE COIL WENT SMOOTHLY THROUGH THE SLEEVE INTO THE HUB. PHYSICIAN WAS PUSHING THE COIL INTO ANEURYSM BUT THE COIL WAS NOT MOVING LATER PHYSICIAN WAS RETERVING COIL BUT NO MOVEMENT WAS HAPPENING. COIL HAD PRE DETACHED BUT THE COIL WAS REMOVED WITH THE HELP OF CATCHMAXI40 COIL BEEN TAKEN OUT AND PHYSICIAN DECIDED TO LEAVE AND CASE WAS COMPLETED WITHOUT ISSUE." INCIDENT REPORT FORM SUBMITTED FOR THIS EVENT INDICATED NO PATIENT INJURY WAS SUSTAINED AS A RESULT OF THIS INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17364144 ↗

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-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.