Optima Coil System OPTI0307CSSMXRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00818053025044), received between Apr 7, 2023 and Apr 7, 2023 — 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.

• MalfunctionApr 7, 2023Migration; Premature Separation; Migration; Premature Separation

  IT WAS REPORTED THAT: "NEURON MAX 90CM, SL10 45 DEGREE MC PARALLEL WITH A SCEPTER XC 4X11. THE PLAN WAS TO DO A BALLOON ASSISTED COILING OF A WIDE NECK SPHERICAL ANEURSYM ON THE ICA. INITIALLY FRAMED WITH A 4X7 OPTIMAX SOFT COMPLEX ALONG WITH BALLOON ASSISTANCE. THE FRAME SET AND DEPLOYED WITHOUT ANY ISSUES. THE FOLLOWING COIL WAS A 3X7 OPTIMAX SUPERSOFT COMPLEX AND AS THE INITIAL PHASES OF DEPLOYMENT WAS INITIATED, A LITTLE RESISTANCE WAS FELT BY THE FELLOW WHEN THE BALLOON WAS UP. THE ATTENDING PHYSICIAN TOOK OVER AND TRIED TO ADVANCE AND PULL BACK AS THE COIL WAS NOT SITTING RIGHT. AS SOON AS HE ATTEMPTED THAT MANEUVER, HE LOST 1:1 CONTROL AND THE COIL PREMATURELY DETACHED WITH IT PARTIALLY IN THE SL10 45 DEGREE MICROCATHETER. CAREFUL REMOVAL OF THE SL10 45 DEGREE WAS ATTEMPTED, HOWEVER THE 3X7 OPTIMAX COIL FLIPPED OUT AND MIGRATED INTO THE MCA. AS A RESULT, THE PHYSICIAN HAD TO SNARE THE THE COIL OUT OF THE MCA AND WAS ABLE TO SAFELY REMOVE THE 3X7 OPTIMAX WHILE KEEPING THE FRAMED COIL (4X7 OPTIMAX SOFT). THE CASE WAS CONCLUDED AFTER REMOVAL OF THE 3X7 OPTIMAX SUPERSOFT AND THE PATIENT IS DOING WELL."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16702315 ↗

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