Optima Coil System OPTI0620COM18 (REF N/A)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00818053026423), received between Jul 23, 2024 and Jul 23, 2024 — 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.

• MalfunctionJul 23, 2024Premature Separation; Premature Separation

  IT WAS REPORTED THAT: "IT WAS A CASE OF RUPTURED ACOM ANEURYSM HAVING TWO LOBES THE PHYSICAN PLANNED TO DO SIMPLE COILING.THE SUPPORT SYSTEM WAS NEURONMAX AND NAVIEN5F, THE HEADWAY 17 WAS PLACED INSIDE THE ANEURYSM WITH SUPPORT OF TRAXCESS14. HEADWAY 17 WAS CONNECTED WITH A FLUSH LINE. THE FIRST COIL OPTIMA 4*13 COMPLEX 10 SOFT WAS PREPARED AS PER IFU AND THEN ALIGNED TO THE HUB OF THE MICRO CATHETER .THE FIRST LOBE WAS COILED.THE SECOND COIL SIZE OF 5*17 OPTIMA COMPLEX10 SOFT WAS PREPARED AS PER IFU AND THEN ALIGNED TO THE HUB OF THE MICRO CATHETER .THE COIL WENT SMOOTHLY THROUGH THE SLEEVE INTO THE HUB OF HEADWAY 17 AND DURING COILING THE PHYSCIAN FELT RESISTANCE AND A GIVE AWAY FEEL SO HE DECIDED NOT TO CONTINUE WITH COIL AND RETRIEVED IT.THE COIL WAS PUSHED IN SALINE BOWL TO CHECK THE COIL , HE NOTICED THAT THE COIL WAS KIND OF STRECHED. HE DECIDED TO USE OPTIMA COMPLEX 18 6*20,IT WAS PREPARED AS PER IFU.THEN ALIGNED TO THE HUB OF THE MICRO CATHETER. THE COIL WENT SMOOTHLY THROUGH THE SLEEVE INTO THE HUB OF HEADWAY 17, AFTER TWO LOOPS OF THE COIL INSIDE THE ANEURYSM THE PHYSCIAN WAS PUSHING THE COIL BUT THE COIL WAS NOT MOVING LATER THE PHYSICIAN WAS RETERVING COIL BUT NO MOVEM

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19806284 ↗

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.