Optima Coil System OPTI0413CSF10 (REF N/A)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00818053021732), received between Dec 9, 2019 and Dec 9, 2019 — 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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 · 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.

• MalfunctionDec 9, 2019Premature Separation; Premature Separation

  IT WAS REPORTED THAT: "THE PHYSICIAN WAS STENT/COILING A PICA ANEURYSM. THE PHYSICIAN HAD A 90CM BALLAST IN THE LEFT VERT, A 072 NAVIAN, A MV DUO IN THE ANEURYSM AND WAS TRYING TO ADVANCE A HEADWAY 17 OVER A 12/14 HYBRID INTO THE PICA. AFTER MANY ATTEMPTS WITH DIFFERENT WIRES, THE PHYSICIAN DECIDED TO ADVANCE A 4X13 COMPLEX SOFT OPTIMA INTO THE ANEURYSM IN HOPES TO HAVE THE HYBRID WIRE "BOUNCE" OFF IT AND INTO THE PICA. THE PHYSICIAN PUSHED OUT ABOUT 3CM OF THE OPTIMA AND THEN ADVANCED THE HYBRID WIRE. THE PHYSICIAN WAS ABLE TO GET ACCESS TO DISTAL PICA AND ADVANCED THE HEADWAY 17 INTO PICA. WHEN THE PHYSICIAN WENT TO PULL BACK SOME OF THE LOOPS OF THE 4X13 COMPLEX SOFT, THE PHYSICIAN NOTICED FRICTION. THE PHYSICIAN PUSHED THE COIL OUT AND THEN TRIED TO PULL IT BACK INTO THE MICROCATHETER. THE PHYSICIAN FELT RESISTANCE AND CONTINUED TO PULL GENTLY AND FELT THE COIL SLIGHTLY GIVE. THE PHYSICIAN THEN PULLED BACK ON THE PUSHER AND COULD TELL THAT IT HAD DETACHED FROM THE COIL. THERE WAS ABOUT 10CM OF COIL IN THE LEFT VERTEBRAL. AFTER MUCH DISCUSSION, THE PHYSICIAN DECIDED TO DEPLOY THE 2.5X23 LVIS JR PARTIALLY AND PUSH OUT THE COIL WITH THE DISTAL END OF THE PUSHER. THE PHYSICIAN WAS

  Patient problems: Aneurysm

  MAUDE report 9440810 ↗

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.