Optima Coil System OPTI0102CSS10 (REF N/A)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00818053025716), received between Sep 21, 2021 and Aug 25, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).

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

• MalfunctionAug 25, 2022Expulsion; Expulsion

  IT WAS REPORTED THAT: "PHYSICIAN WAS COILING OFF A SHALLOW BASILAR REOCCURRENCE. HE WAS ON HIS FINAL COIL, A 1 X2 OPTIMA COMPLEX SUPER SOFT. THE DEPLOYMENT WENT WELL. THE OPTIMA WAS DETACHED AND THE PUSHER WAS REMOVED. THEN DOCTOR REMOVED THE CATHETER AND THE 1/2 OF THE COIL WAS DRUG OUT BY THE MICRO CATHETER. WITH ABOUT 1 CM OF THE COIL IN THE PARENT ARTERY HE DECIDED TO LAY DOWN ANOTHER STRYKER ATLAS OUT THE OTHER PCA BRANCH. THE PATIENT IS DOING FINE WITH NO ISSUES." 28JUL2022, ADDITIONAL INFORMATION PROVIDED - "NO INJURY TO THE PATIENT OCCURRED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15294619 ↗
• MalfunctionSep 21, 2021Detachment of Device or Device Component; Migration; Detachment of Device or Device Component; Migration

  IT WAS REPORTED THAT: "PHYSICIAN JAILED A MICRO BEHIND AN ATLAS STENT IN ORDER TO TREAT AN ICA ANEURYSM. LAST COIL KICKED THE MICRO OUT AND THE PHYSICIAN ATTEMPTED TO RIDE MICRO OVER COIL TO GET BACK INTO POSITION SEVERAL TIMES AND COIL PREMATURELY. PHYSICIAN STENTED OVER COIL TAIL THAT DID NOT GO INTO THE ANEURYSM. FOLLOW UP (B)(6) 2021: THERE WAS A STENT ALREADY IN PLACE WHICH ADDED A LAYER OF DIFFICULTY AND MAY HAVE CONTRIBUTED. THERE WAS AN ADDITIONAL STENT USED AFTER."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12510426 ↗

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.