Optima Coil System OPTI0520CSF10 (REF N/A)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00818053026164), received between Feb 13, 2025 and Feb 13, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Migration” (1 report).

2 FDA recall records name this device's identifier, 2 still open.

3 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 ↗

2. Jul 26, 2022Open, Classified

   Products were released to customers prior to the approval and release of a test report authorizing the use of an existing material from an alternate supplier.

   Z-1680-2022 · Root cause: Under Investigation by firm · 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.

• MalfunctionFeb 13, 2025Migration; Premature Separation; Migration; Premature Separation

  IT WAS REPORTED THAT: "PROCEDURE- CCF COILING. ACCESSORIES- VASCO10D,HYBRI1214D. AS PER PHYSICIAN THEY DECIDED TO USE THIRD OPTIMA COIL 5X20 WHICH THEY PREPARED AS PER IFU STARTED COILING THE RENT OF CCF BUT WHILE DOING COILS THEY NEEDED TO REPOSITION COILS BUT WHILE DOING THAT COIL GOT DETACHED AUTOMATICALLY SO THEY TRIED PULLING OUT BOTH COIL & CATHETER BUT COULDN'T ABLE TAKE OUT COIL SO THEY MANAGED THE CASE BY DEPLOYING OTHER COILS & COMPLETED CASE SUCCESSFULLY." UPDATE 17JAN2024 - ADDITIONAL INFORMATION RECEIVED FROM THE ISSUER: "- COIL FLEW INTO DISTAL BRANCH AND PHYSICIAN TRIED BUT COULD NOT RETRIEVE SO KEPT PATIENT ON MEDICAL MANAGEMENT . - TORTUOSITY WAS NOT MUCH AS THEY REACHED LOCATION WITHOUT TROUBLE & DEPLOYED FEW OPTIMA COILS BEFORE THIS INCIDENT . - NO ACCESSORIES NOT AVAILABLE TO RETURN AS PER HOSPITAL PROTOCOL THEY DISCARD ALL USED MEDICAL DEVICES." INCIDENT REPORT FORM SUBMITTED FOR THIS COMPLAINT INDICATES THAT NO PATIENT INJURY WAS SUSTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21375636 ↗

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-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