Optima Coil System OPTI0620CST10 (REF N/A)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00818053026324), received between Apr 17, 2020 and Apr 21, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Device Slipped” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 21, 2023Premature Separation; Premature Separation

  IT WAS REPORTED THAT: "THE PHYSICIAN WAS TREATING A CASE OF A-COM ANEURYSM PROCEDURE. THE PLAN WAS TO DO SIMPLE COILING. HE SUCCESSFULLY GOT ACCESS AND DEPLOYED TWO OPTIMA COILS AND DURING THE 3RD COIL DEPLOYMENT OF 6X20CM, HE FOUND THAT COIL GOT DETACHED PREMATURELY INSIDE THE MICRO CATHETER PROXIMAL TO ITS LENGTH. HE TRIED T0 TOOK IT OUT ALONG WITH THE MICRO CATHETER, BUT IT DIDN'T CAME OUT THEN HE USE A SOLITAIRE DEVICE TO RETRIEVE IT AND GOT SUCCESS. HE AGAIN PLACED THE MICRO CATHETER INSIDE THE ANEURYSM AND COMPLETED THE PROCEDURE WITH OTHER SIZES OF OPTIMA COILS." (B)(6) 2023, ADDITIONAL INFORMATION RECEIVED FROM THE ISSUER: "THE PROCEDURE WAS CONTINUED WITHOUT ANY INJURY."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16785974 ↗
• MalfunctionApr 17, 2020Device Slipped; Device Slipped

  IT WAS REPORTED THAT: "THE COIL WAS RUPTURED DURING INSERTION PROCESS. PART OF THAT WAS LEFT IN ANEURYSM AND THE RES - OUT OF THE ANEURYSM. PATIENT GOT OPEN SURGERY TO REMOVE THE RESIDUAL PARTS."

  Patient problems: Aneurysm

  MAUDE report 9975410 ↗

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.