Optima Coil System OPTI0509CSF10 (REF N/A)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00818053026140), received between Mar 28, 2025 and Mar 28, 2025 — classified as 1 malfunction.

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

• MalfunctionMar 28, 2025Migration; Premature Separation; Migration; Premature Separation

  IT WAS REPORTED THAT: "PATIENT INFORMATION: SEX: UNKNOWN DISEASE NAME: 5MM ANEURYSM IN A-COM, PROCEDURE: PLANNED PROCEDURE, GUIDING CATHETER: ESPERANCE DISTAL ACCESS CATHETER/JAPAN LIFELINE Y CONNECTOR: UNKNOWN, USED COILS, MICROCATHETER, AND ASSIST STENT: 1. OPTIMA SOFT 5X9 (LOT# F210900201) (IT WILL BE REPORTED AS YA2024-1268.) 2. OPTIMA SOFT 5X9 (LOT# F210800307), SL-10 45°(IT WILL BE REPORTED AS YA2024-1269.) 3. OPTIMA SS 4X8 (LOT# UNKNOWN), SL-10 STRAIGHT. 4. OPTIMA SS 4X8 (LOT# UNKNOWN), SL-10 STRAIGHT. 5. OPTIMA SS 2.5X4 (LOT# UNKNOWN), SL-10 STRAIGHT. 6. OPTIMA SS 1.5X2 (LOT# UNKNOWN), SL-10 STRAIGHT. NEUROFORM ATLAS STENT SYSTEM 3X21/STRYKER. DESCRIPTION: THE PROCEDURE WAS PERFORMED ON AN ANEURYSM OF THE A-COM. AN ATTEMPT WAS MADE TO USE THE OPTIMA SOFT 5X9 (LOT# F210900201) AS THE FIRST COIL, BUT IT WAS DIFFICULT TO ADVANCE WITHIN THE INTRODUCER SHEATH, AND THE PHYSICIAN FELT DISCOMFORT. THEREFORE, A NEW OPTIMA SOFT5X9 (LOT# F210800307) OF THE SAME SIZE WAS PREPARED, AND THE PROCEDURE WAS CONTINUED. (IT WILL BE REPORTED AS YA2024-1268.) FOR AN ANEURYSM AT THE A-COM, EMBOLIZATION WAS ATTEMPTED USING A DOUBLE CATHETER TECHNIQUE WITH THE MICROCATHETERS SL-10 45° AND SL-10 ST

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21721467 ↗

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.