Optima Coil System OPTI0256CSS10 (REF N/A)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00818053025853), received between Mar 10, 2022 and Jan 31, 2025 — classified as 3 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.

2 other recalls cover devices cleared under the same FDA submission (K172390); 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.

• MalfunctionJan 31, 2025Nonstandard Device; Nonstandard Device

  ON DECEMBER 15, 2024, BALT USA RECEIVED COMPLAINT: (B)(4) (LOT: F230800685) FROM (B)(6). IT WAS REPORTED, "DURING DEPLOYMENT OF THE COIL IN THE ANEURYSM, THE RADIOPAQUE MARKER OF THE DETACH ZONE COULD NOT BE SEEN USING ANGIOGRAPHY. AFTER MOVING SEVERAL TIMES, IT COULD NOT BE SEEN AND WAS REMOVED." THE RETURNED UNIT WAS ANALYZED IN-HOUSE AND THEN SENT TO A SENT FOR MATERIAL ANALYSIS TO AN EXTERNAL MATERIALS CHARACTERIZATION LAB FOR FURTHER TESTING. ON JANUARY 3, 2025, THE ANALYSIS FROM THE MATERIALS CHARACTERIZATION LAB WAS RECEIVED WHICH CONCLUDED THE MATERIALS OF THE RO MARKER ALONG THE DELIVERY PUSHER ARE CONSISTENT WITH A 300 SERIES STAINLESS STEEL. THIS DATA SUPPORTS THE MATERIAL BEING THE CAUSE FOR THE VISIBILITY ISSUE DESCRIBED IN COMPLAINT#: (B)(4) CONFIRMING THE RO MARKER WAS NOT MADE WITH THE INTENDED WIRE MATERIAL TO BE ABLE TO EASILY VISUALIZE THE RADIOPAQUE SECTION OF THE DELIVERY PUSHER. FOR THIS REASON, BALT USA INITIATED HHE-031 ON 03JAN2025 FOR THIS ISSUE TO FULLY ASSESS THE IMPACT OF THE SUPPLIER'S HYPOCOIL SUBASSEMBLY BEING MANUFACTURED USING THE UNINTENDED COIL WIRE MATERIAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21289088 ↗
• MalfunctionAug 18, 2023Premature Separation; Premature Separation

  IT WAS REPORTED THAT: "WHEN THE 0256CSS COIL WAS INSERTED INTO THE ANEURYSM, IT SUDDENLY DETACHED AND AROUND HALF WAS FLOATING AND BLOCKING THE BLOOD VESSEL. THE PHYSICIAN PUSHED IN A 0154CSS AND TOOK EMERGENCY MEASURES, BUT THE BLOOD VESSEL FROM THE OUTSIDE OF THE ANEURYSM TO THE PCOM WAS BLOCKED. THEREFORE, AFTER REMOVING THE 0154CSS, IT WAS RE-ADJUSTED. FORTUNATELY, IT WAS JUDGED THAT THERE WAS NO SIGNIFICANT HARM TO THE PATIENT AND THE PROCEDURE WAS CLOSED." 09NOV2022, ADDITIONAL INFORMATION PROVIDED BY ISSUER - "·REGARDING THE UNIT UNDER REFERENCE ((B)(6)): WAS THE 0154CSS COIL A PART OF THE INITIAL PLANNED PROCEDURE OR WAS THIS A PHYSICIAN INTERVENTION? (B)(6)'S ANSWER: BOTH ARE CORRECT. THE DOCTOR PLANNED ON USING IT AFTER 0256CSS, BUT SINCE THE 0256CSS WAS PRE-DETACHED 0154CSS WAS USED. WAS A DETACHMENT CYCLE ATTEMPTED FOR THE 0256CSS COIL? TAEWOONG'S ANSWER: THE PROBLEM OCCURRED BECAUSE IT WAS DETACHED WITHOUT DETACHMENT ATTEMPT. CAN YOU CONFIRM THAT THE 0154CSS COIL WAS NOT DETACHED IN THE ANEURYSM? TAEWOONG'S ANSWER: THERE WERE NO PROBLEMS WITH 0154CSS COIL. 0256CSS WAS NOT DETACHED, AND COULD NOT BE COMPLETELY PUSHED WITH 0154CSS, SO IT WAS SLIGHTLY PROTRUDED INTO THE B

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17573384 ↗
• MalfunctionMar 10, 2022Premature Separation; Premature Separation

  IT WAS REPORTED THAT: WHEN THE PHYSICIAN TRIED TO INSERT OPTIMA AS SIXTH COIL IN STENT ASSISTED PROCEDURE, THE COIL PROTRUSION INTO THE STENT LUMEN SO THE PHYSICIAN TRIED TO REPOSITION IT. THEN HE FELT RESISTANCE. HE FOUND THE COIL WAS DETACHED. COIL WAS RETRIEVED USING SNARE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13721338 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K172390. 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.