Optima Coil System OPTI0102HSSMXRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00818053025396), received between Nov 22, 2023 and Nov 22, 2023 — classified as 1 malfunction.

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

1 FDA recall record name this device's identifier, 1 still open.

4 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. 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 22, 2023Detachment of Device or Device Component; Migration; Detachment of Device or Device Component; Migration

  IT WAS REPORTED THAT: "RIGHT PCA ANEURYSM RADIAL ACCESS WITH WRIST CATHETER AND SL 10 MICRO. THE ANEURYSM WAS DISTAL PCA NEAR BIFURCATION, IT WAS A RECANALIZATION. THE PHYSICIAN TREATED THE ANEURYSM WITH BALT COILS AND IT WAS GOING WELL. THE FINAL COIL WAS GOING IN AND THE PHYSICIAN WAS HAPPY WITH THE COIL PLACEMENT AND WENT TO DETACH AND THE COIL WOULD NOT DETACH. THE PHYSICIAN TRIED TO ADVANCE THE COIL FURTHER OUT OF THE MICRO AND MANIPULATED THE COIL BACK AND FORTH SEVERAL TIMES AND THE PREVIOUS COIL OF THE SAME SIZE WAS DISLODGED AND WENT INTO THE PROXIMAL P2. THE DOC PULLED THE COIL OUT AND WAS VERY UNHAPPY AND WENT IN WITH A MICRO WIRE AND SL10 TO PUSH THE COIL FURTHER DISTAL IN THE P2. THE DOC SAID HE COULD NOT RETRIEVE IT AND ENDED THE CASE THERE." INCIDENT REPORT FORM SUBMITTED FOR THIS COMPLAINT INDICATES THAT NO PATIENT INJURY WAS SUSTAINED. 24OCT2023, ADDITIONAL INFORMATION PROVIDED BY ISSUER - "THE PATIENT IS DOING WELL TO MY UNDERSTANDING."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18193328 ↗

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-1988-2025 · May 8, 2025 · Open, Classified
  Optima Coil System REFs/UDI-DI codes: OPTI0156BLK 00810068568875 OPTI0158BLK 00810068568882 OPTI0103BLK 00810068568851 OPTI0258BLK 00810068568929 OPTI0212BLK 00810068568912 OPTI020
• 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