Optima Coil System OPTI0410CSS10 (REF N/A)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00818053025952), received between Aug 1, 2022 and Apr 23, 2026 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Expulsion” (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.

• MalfunctionApr 23, 2026Stretched; Expulsion

  IT WAS REPORTED THAT: "DURING THE ENDOVASCULAR EMBOLIZATION PROCEDURE, AN ATTEMPT WAS MADE TO IMPLANT THE OPTIMA COMPLEX MICROCOIL (4 MM X 10 CM) AT THE TARGET SITE. AFTER PLACEMENT AND ACTIVATION OF THE DELIVERY WIRE, A FAILURE IN MECHANICAL EXPANSION WAS OBSERVED. THE COIL DID NOT ASSUME THE EXPECTED SPATIAL CONFORMATION (LOOP FORMATION), REMAINING LINEAR OR INSUFFICIENTLY EXPANDED WITHIN THE MICROCATHETER/VESSEL. DUE TO THE RISK OF MIGRATION OR INADEQUATE OCCLUSION DUE TO LACK OF ANCHORAGE, THE DEVICE WAS COMPLETELY REMOVED FROM THE PATIENT. A NEW (SPARE) UNIT WITH IDENTICAL SPECIFICATIONS WAS REQUESTED TO CONTINUE THE PROCEDURE. THE REPLACEMENT ALLOWED THE EMBOLIZATION TO BE SUCCESSFULLY COMPLETED WITHOUT CLINICAL HARM TO THE PATIENT." INCIDENT REPORT FORM SUBMITTED FOR THIS COMPLAINT INDICATES THAT NO PATIENT INJURY WAS SUSTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24968082 ↗
• MalfunctionAug 18, 2023Inaccurate Information; Inaccurate Information

  IT WAS REPORTED THAT: "MY QUALITY DEPT. BROUGHT TO MY ATTENTION THAT SHIPMENT FROM MAY UNDER (B)(4) ARRIVED WITH THE DIFFERENCES BELOW." THE EXPIRATION DATE ON THE CERTIFICATE OF CONFORMANCE INDICATES AN EXPIRATION DATE OF 08MAY2027 HOWEVER, THE ACTUAL PRODUCT WAS LABELED WITH AN EXPIRATION DATE OF 06MAY2027 PER CUSTOMER'S IMAGE. INCIDENT REPORT FORM RECEIVED FOR COMPLAINT INDICATES NO PATIENT INJURY WAS SUSTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17573015 ↗
• MalfunctionAug 1, 2022Break; Expulsion; Break; Expulsion

  IT WAS REPORTED THAT: "PICA ANEURYSM AND AFTER 4-5 MANIPULATIONS IN THE ECHELON 10 MC (45 DEGREE) THE COIL BROKE: HALF WITHIN THE ANEURYSM AND OTHER HALF IN THE MC. THUS LOSING CONTROL OF THE COIL AND THE REMAINING COIL HAD TO BE PUSHED OUT OF THE MC. AS A RESULT, THE COIL TAIL HERNIATED INTO THE PARENT VESSEL LEADING TO AN UNWANTED DEPLOYMENT OF A STENT. THIS CAUSE THE PATIENT TO BE ON DAPT AND INCREASED THE CASE TIME SIGNIFICANTLY." 26 JUL 2022, CUSTOMER PROVIDED ADDITIONAL INFORMATION: (1) NO PATIENT INJURY, JUST HAD TO DROP A STENT CAUSING UNWANTED MEDICAL MANAGEMENT. (2) FRICTION WAS FELT AFTER 4-5 MANIPULATIONS AS THAT'S WHEN THE COIL BROKE. (3) YES IT WAS TORTUOUS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15138592 ↗

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.