Optima Coil System OPTI1040CSFMXRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00818053025280), received between Jul 28, 2025 and Jul 28, 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. May 8, 2025Open, Classified

   Due to radiopaque (RO) marker was not visible during angiography and it was determined that the RO marker was not manufactured to specification.

   Z-1988-2025 · Root cause: Vendor change control · FDA record ↗

2. 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 28, 2025Stretched; Migration; Premature Separation; Stretched; Migration; Premature Separation

  IT WAS REPORTED THAT: "<PATIENT INFORMATION> SEX: UNKNOWN DISEASE NAME: AS PER BELOW. PROCEDURE: UNKNOWN MICRO CATHETER: HEADWAY 17/TERUMO ASSIST STENT: ENTERPRISE/JOHNSON&JOHNSON Y CONNECTOR: UNKNOWN USED COILS: UNKNOWN. <DESCRIPTION> IN THIS CASE OF RECANALIZATION OF A LARGE ANEURYSM OVER 15 MM NEAR THE P1 SEGMENT, AN ASSISTING ENTERPRISE STENT WAS DEPLOYED IN THE PARENT VESSEL AND THE MICROCATHETER WAS JAILED TO INITIATE THE PROCEDURE. WHILE INSERTING THE OPTIMA COIL SYSTEM AS THE FIRST COIL AND ADVANCING IT APPROXIMATELY 30 CM, THE OPERATOR INADVERTENTLY CAUGHT THEIR HAND, CAUSING THE MICROCATHETER TO RETRACT SIGNIFICANTLY, DISLODGING IT FROM THE STENT AND RESULTING IN THE TIP MOVING FAR DISTALLY INTO THE BASILAR ARTERY, AWAY FROM THE ANEURYSM. SUBSEQUENT ATTEMPTS WERE MADE TO RE-NAVIGATE THE MICROCATHETER BACK INTO THE ANEURYSM, BUT THE COIL HAD STRETCHED, MAKING IT IMPOSSIBLE TO RETRACT THE COIL INTO THE MICROCATHETER. FURTHER ATTEMPTS TO RETRIEVE THE COIL USING A SNARE AND OTHER DEVICES WERE UNSUCCESSFUL, AS THE COIL BROKE DURING THE RETRIEVAL PROCESS AND ULTIMATELY COULD NOT BE RECOVERED. FINALLY, THE MICROCATHETER WAS REINSERTED THROUGH THE STENT STRUTS, WITH THE TAIL OF T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22631509 ↗

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-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.
• 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