Optima Coil System OPTI1860COM18 (REF N/A)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00818053026539), received between Dec 4, 2025 and Dec 4, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Premature Separation” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 4, 2025Premature Separation; Premature Separation

  IT WAS REPORTED THAT: "DURING EMBOLIZATION OF THE SPLENIC ARTERY ANEURYSM OF PATIENT MECS 1 WITH AN 18 X 60 COIL COMPLEX, THE BODY PART OF THE UPPER COIL RUPTURED NEAR THE MICROCOIL INSIDE THE MICROCATHETER AND WAS REMOVED FROM THE ASSEMBLY USING THE RIGID HYDROPHILIC GUIDEWIRE 035 X 260." UPDATE 04NOV2025 - ADDITIONAL INFORMATION RECEIVED FROM THE ISSUER: "DID THE PROCEDURE INVOLVE TORTUOUS ANATOMY? REGARDING THE ANATOMY, WE CANNOT SAY THAT THERE WAS SEVERE TORTUOSITY. WE CHARACTERIZED THE ANATOMY OF THIS CASE WITHOUT ANY OBSERVATIONS. WILL THE MICROCATHETER BE AVAILABLE FOR RETURN? NO. CAN YOU CONFIRM IF THE DEVICE WAS IMPLANTED? NO, THE DEVICE WAS NOT IMPLANTED AND IT WAS REPLACED. DID THE IMPLANT'S MICROCOIL DETACH FROM THE DELIVERY WIRE WITHOUT THE USER PRESSING THE DISCONNECT BUTTON? THAT'S EXACTLY WHAT HAPPENED. IF THE IMPLANTED MICROCOIL DETACHED, WHERE DID THIS OCCUR (INSIDE THE ANEURYSM, INSIDE THE MICROCATHETER, ETC.)? THE DETACHMENT OCCURRED INSIDE THE MICROCATHETER. COULD YOU PROVIDE A MORE DETAILED EXPLANATION OF WHAT "REMOVED FROM THE ASSEMBLY USING THE 035 X 260 RIGID HYDROPHILIC GUIDEWIRE" MEANS? THE HYDROPHILIC GUIDEWIRE WAS PASSED THROUGH THE SPRING AND, WITH ROT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23719901 ↗

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.