Optima Coil System OPTI4510CSFMXRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00818053025143), received between Mar 29, 2022 and May 10, 2024 — classified as 2 malfunctions.

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

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 10, 2024Migration; Premature Separation; Migration; Premature Separation

  IT WAS REPORTED THAT: "PROCEDURE WAS THE EMBOLIZATION OF A LEFT CAROTID-CAVERNOUS FISTULA (CCF). ACCESS WAS ACHIEVED VIA TRANS-FACIAL VEIN, WHICH REQUIRED SIGNIFICANT TURNS DUE TO TORTUOSITY. THE NAVIGATING MICROCATHETER WAS AN SL-10. ONCE ACCESS WAS ACHIEVED, COIL EMBOLIZATION BEGUN. THE FIRST COILS (7X15MX, 6X11MX, 5X17MX AND 6X20MX) WERE DEPLOYED AND DETACHED NORMALLY. THE NEXT COIL (8X30MX) WAS PUSHED THROUGH THE SL10 WITHOUT ISSUE. ONCE THE COIL SHAPED TO THE PHYSICIAN'S LIKING, SLIGHT ADDITIONAL ADJUSTMENTS WERE MADE (FORWARD AND BACK), THE COIL DETACHED ON ITS OWN. THE PHYSICIAN MADE NOTE, HOWEVER, IT WAS IN A SAFE POSITION WITHIN THE FISTULA. HE THEN ELECTED TO USE A 4.5X10MX COIL NEXT. DURING THE DEPLOYMENT, THE COIL HERNIATED INTO THE ICA, AND THEN DETACHED/SEPARATED WITHOUT WARING/RESISTANCE. THE COIL MASS THEN MIGRATED TO THE ICA TERMINUS,AND BEGINNING TO MOVE TO THE PATIENTS L MCA. THE PHYSICIAN THEN USED A TREVO TRAK TO RETRIEVE THE COIL. THE PHYSICIAN WAS SUCCESSFUL AND THE PATIENT HAD NO INJURY. I WAS ABLE TO SAVE THE BENCHMARK 71, TREVO TRACK, AND COIL MASS WITHIN THE TREVO.". UPDATE 15APR2024 - ADDITIONAL INFORMATION RECEIVED FROM THE ISSUER: "THERE WERE NO ATTEMP

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19287161 ↗
• MalfunctionMar 29, 2022Premature Separation; Premature Separation

  IT WAS REPORTED THAT: "AS THE PHYSICIAN WAS PUSHING THE COIL BACK AND FORTH IN THE ANEURYSM THE COIL PREMATURELY DETACHED. HE WAS USING AN SL-10 MICRO CATHETER. HE ENDED UP USING A TREVO STENT RETRIEVER TO SNARE IT OUT. THE LOCATION WAS A LEFT CAROTID TERMINUS." UPDATE 03MAR2022 - ADDITIONAL INFORMATION RECEIVED FROM THE ISSUER: "WAS THIS THE FIRST COIL OF THE PROCEDURE, OR WERE THERE OTHER COILS/DEVICES AT THE TREATMENT SITE? YES FIRST COIL. WILL THE MICROCATHETER BE RETURNING WITH THE COIL SYSTEM FOR ANALYSIS? NO MICRO WAS THE ANATOMY TORTUOUS AT ALL? IT WAS NOT TORTUOUS."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13934925 ↗

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