Optima Coil System OPTI0830CSFMXRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00818053025259), received between Aug 25, 2023 and Mar 18, 2026 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Premature Separation” (2 reports).

1 FDA recall record name this device's identifier, 1 still open.

4 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. 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 18, 2026Premature Separation

  IT WAS REPORTED THAT: "<PATIENT INFORMATION> SEX: UNKNOWN DISEASE NAME: RUPTURED ANEURYSM AT A-COM PROCEDURE: EMERGENCY PROCEDURE MICRO CATHETER: HEADWAY ASSIST STENT: UNKNOWN GUIDE WIRE: UNKNOWN ASSIST BALLOON: UNKNOWN Y CONNECTOR: UNKNOWN USED COILS: OPTIMAX. <DESCRIPTION> FOR AN 8 MM RUPTURED ANEURYSM OF THE A-COM, OPTIMAX 8×30 WAS SELECTED AS THE FIRST COIL. THE MOVEMENT OF THE COIL WAS SMOOTH, BUT ITS SHAPE DID NOT STABILIZE, SO IT WAS REINSERTED INTO THE RUPTURED ANEURYSM SEVERAL TIMES. THEN, THERE WAS A SNAPPING SOUND, AND THE PREMATURE DETACHMENT OCCURRED AT THE JUNCTION BETWEEN THE COIL AND THE DELIVERY PUSHER. THE COIL WAS RETRIEVED WITH A SNARE. " INCIDENT REPORT FORM SUBMITTED FOR THIS COMPLAINT INDICATES THAT NO PATIENT INJURY WAS SUSTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24635150 ↗
• MalfunctionFeb 20, 2024Stretched; Premature Separation; Stretched; Premature Separation

  IT WAS REPORTED THAT: "<PATIENT INFORMATION> SEX: UNKNOWN. DISEASE NAME: 10MM AN IN IC-TOP. PROCEDURE: EMERGENCY PROCEDURE. MICRO CATHETER: SL-10/STRYKER. ASSIST STENT: UNKNOWN. Y CONNECTOR: UNKNOWN. USED COILS: OPTIMAX, 2 TARGETXCEL/STRYKER. <DESCRIPTION> AFTER PLACING 1 OPTIMAX COIL AND 2 TARGETXCEL COILS, THE PHYSICIAN INSERTED OPTIMAX 8×30(REPORTED COIL) . THE PHYSICIAN PERFORMED SEVERAL ATTEMPTS OF REPOSITIONING. AFTER REPEATED ATTEMPTS, THE PHYSICIAN FOUND THAT, DESPITE HE OPERATED DELIVERY WIRE THE IMPLANT COIL(THE TIP OF IT WAS PLACED IN THE TARGET LESION) DID NO MOVE NO LONGER. IT TURNED OUT THAT THE IMPLANT COIL GOT UNRAVELED AND RETRIEVING ATTEMPT WITH SNARE WERE DIFFICULT. EVENTUALLY, THE IMPLANT COIL WAS TORN OFF AND PARTIALLY REMAINED IN THE ANEURYSM AND SOME PART OF FILAMENT REMAINED IN THE MOTHER VESSEL. AFTER THAT THE PROCEDURE WAS CONTINUED WITH COMPETITIVE COILS AND THE LOOP OF COIL HAS BEEN PUSHED OUT OF THE ANEURYSM. THUS THE PHYSICIAN COMPLETED PROCEDURE BY JACKING UP THE STENT AND HOLDING DOWN PART OF THE OPTIMAX STRAND WITH THE STENT, ALTHOUGH IT WAS A SAH. IT IS UNKNOWN WHETHER THE PHYSICIAN PERFORMED BEFORE USE CHECK OR NOT." INCIDENT REPORT FORM SUBMITTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18741638 ↗
• MalfunctionAug 25, 2023Fracture; Fracture

  IT WAS REPORTED THAT: "DR. (B)(6) DOING A FRED PLUS COIL CASE. HE HAD AN ECHELON 10 IN THE ANEURYSM AND PHENOM PLUS FOR THE FRED. HE BROUGHT UP THE COIL AND FELT SOME RESISTANCE BUT HE THOUGHT BECAUSE THERE WAS A TIGHT LOOP IN THE ICA WAS THE RESISTANCE. HE DEPLOYED SMALL AMOUNT OF COIL BEFORE DEPLOYING THE FLOW DIVERTER. DEPLOYED FLOW DIVERTER THEN STARTED PUSHING THE COIL AND FELT SOME RESISTANCE. HE GOT MOST OF COIL IN AND DECIDED TO REMOVE. HE BEGAN REMOVING AND COIL WAS UNDER RESISTANCE. THE COIL POPPED OFF OF PUSHER AND THEN PUSHER STRECHED AND FRACTURED LEAVING A LONG STRAND OF PUSHER IN THE PARENT ARTERY LEADING ALL THE WAY DOWN TO ARCH." INCIDENT REPORT FORM SUBMITTED TO BALT INDICATED THAT NO PATIENT INJURY WAS SUSTAINED. (B)(6) 2023, ADDITIONAL INFORMATION PROVIDED BY THE ISSUER - "PATIENT WAS RELEASED DAY AFTER WITH NO ISSUES. THE NO ADDITIONAL PROCEDURES WERE DONE TO REMOVE THE COIL IN THIS CASE. THE COIL DETACHED FROM THE PUSHER. HE USED SALINE IN A SYRINGE TO PUSH AS MUCH AS THE COIL OUT AS HE COULD. THERE WERE NO ADDITIONAL COILS USED. JUST THE ONE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17627136 ↗

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-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