Optima Coil System OPTI4510CSF10Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00818053026133), received between Jul 27, 2026 and Jul 27, 2026 — classified as 1 injury.

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

• InjuryJul 27, 2026Separation Problem

  It was reported that:"The Physician planned to treat Acom Aneurysm and primed the Vasco 10 Micro catheter after Prechecked the Optima Complex 4.5x10 coil he placed it inside the aneurysm and tried to detach the coil. After Multiple attempts and tried all the techniques the coil didn't detach so he tried to resheath the coil into the micro catheter the coil got detached halfway into the fargo guiding catheter. The Physician Removed the coil by aspirating and used another Optima to Finish the Procedure."UPDATE 29JUN2026 - Additional information received from the issuer:"1. the vessel was torturous.2. The Detacher, Micro catheter is not available for return.3. Precheck was performed on the coil.4. the Xcel showed red and green light when the Physician was ready to detach. We tried rotating the Xcel, wiping the detachment gold marker end, still red and green light was blinking."Incident Report Form submitted for this complaint indicates that no patient injury was sustained.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50015103 ↗

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