Optima Coil System OPTI0413CSFMXRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00818053025129), received between Dec 23, 2021 and Mar 11, 2026 — classified as 1 injury, 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryMar 11, 2026Migration; Premature Separation

  IT WAS REPORTED THAT: "THE PHYSICIAN WAS TREATING A LARGE OPTHALMIC ANEURYSM WITH A PRIMARY COILING TECHNIQUE. WE WERE ROUGHLY 4 COILS INTO TREATMENT WHEN WE TRIED TO USE A 4MMX13CM MAX COIL. WE DID MAKE A FEW ADJUSTMENTS OF THE COIL TO TRY TO GET IT TO SIT PROPERLY. UPON THE THIRD ADJUSTMENT, THE COIL KICKED THE MICRO OUT OF THE ANEURYSM. THE PHYSICIAN PULLED COIL BACK AND TRIED TO ADVANCE MICRO BACK INTO ANEURYSM. WHILE DOING THAT---THE COIL PRE-MATURELY DETATCHED. WE HAD TO USE SEVERAL TECHNIQUES TO RETRIEVE COIL AND COIL WAS ULTIMATELY RETRIEVED WITH A STENTRIEVER. THERE WAS MODERATE VESSEL TOURTOSITY BUT THE COIL SHOULD ABSOLUTELY BE MORE DURABLE THAT IT WAS. THE PRE-MATURE DETATCHED COIL DID END UP TRAVELING INTO THE MCA DURING RETRIEVEL ATTEMPTS--BECAUSE OF THIS, THE PATIENT ENDED UP HAVING CLOT AT THE M1 BIFURCATION THAT WAS REMOVED WITH A RED 43 ASPIRATION CATHETER." INCIDENT REPORT FORM SUBMITTED FOR THIS COMPLAINT INDICATES THAT NO PATIENT INJURY WAS SUSTAINED.

  Patient problems: Thromboembolism

  MAUDE report 24575688 ↗
• MalfunctionSep 16, 2022Fracture; Stretched; Fracture; Stretched

  IT WAS REPORTED THAT: "15 X 14 ICA ANEURYSM. TOOK 16 COMPLEX 18 AND OPTIMAX COILS. THE 17TH COIL WAS A 4X13 MAX BUT WAS HAVING TROUBLE GOING IN, MANIPULATED MC MANY TIMES, COIL WAS HALF IN ANEURYSM, PULLED GENTLY TO REMOVE AND STARTED TO UNRAVEL. AFTER 2 HOURS WE WERE ABLE TO SNARE WITH NO HARM TO PATIENT." 25AUG2022, ADDITIONAL INFORMATION: "CAN YOU CLARIFY WHAT HAPPENED IN THE INCIDENT? WAS THE IMPLANT STILL CONNECTED TO THE DELIVERY PUSHER? YES. WAS THE IMPLANT DETACHED USING THE CONTROLLER WHEN IT WAS HALF IN THE ANEURYSM? OR DID THE COIL PREMATURELY DETACH? THEY EVENTUALLY PULLED COIL ENOUGH FROM BACK END THAT IT BROKE OFF FROM PUSHER WIRE." 12SEP2022, ADDITIONAL INFORMATION: DISCUSSION WITH THE SALES REPRESENTATIVE PRESENT DURING THE CASE INDICATED THAT THE PHYSICIAN NOTICED THAT THE IMPLANT BECAME STRETCHED AND BROKE FROM THE DELIVERY PUSHER AFTER IT WAS NOTED THAT THERE WAS NO MORE MOVEMENT WITH THE IMPLANT WHILE STILL RETRACTING THE DELIVERY PUSHER WHEN ATTEMPTING TO MANIPULATE THE COIL TO BETTER SEAT THE IMPLANT. THE IMPLANT COIL WAS THEN SNARED OUT IN APPROXIMATELY 6 DIFFERENT PIECES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15438691 ↗
• MalfunctionDec 23, 2021Premature Separation; Premature Separation

  IT WAS REPORTED THAT: "PREMATURE DETACHMENT OF THE COIL DURING COIL POSITIONING INTO THE EMBOLIZATION SITE. MICROCATHETER USED TO DELIVER THE COIL: EXCELSIOR 17XT STRAIGHT. COIL RETRIEVED WITH A LASSO SYSTEM." FOLLOW UP 10DEC2021 - ADDITIONAL INFORMATION RECEIVED FROM ISSUER: " WAS THERE TORTUROUS ANATOMY INVOLVED? NO." FOLLOW UP 13DEC2021: - ADDITIONAL INFORMATION RECEIVED FROM ISSUER: "WHERE DID THE IMPLANT PREMATURELY DETACH? DID IT OCCUR INSIDE OF THE MICROCATHETER? ABSOLUTELY!"

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13078526 ↗

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