Optima Coil System OPTI0306CSS10 (REF N/A)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00818053021534), received between Jan 28, 2021 and Jan 28, 2021 — 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.

3 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. 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.

• MalfunctionJan 28, 2021Device Slipped; Detachment of Device or Device Component; Device Slipped; Detachment of Device or Device Component

  IT WAS REPORTED THAT: "IT WAS THE FIRST COIL (TARGET 3X8) TO EMBOLISM ANEURYSM, BUT, THE COIL (TARGET 3X8) WAS RETRIEVED DUE TO MISMATCH OF COIL SIZE. WHEN THE SECOND (OPTIMA 3×6) COIL WAS INSERTED TO THE END, THE COIL CAME OUT OF THE ANEURYSM. THEREFORE, WHEN THE COIL WAS PULLED BACK ONCE AND INSERTED ABOUT 2 ~ 3 LOOPS, THE COIL WAS UNINTENTIONALLY DETACHED, AND SOME PART OF THE COIL WAS HANGING FROM THE ANEURYSM ABOUT 4CM. THEREFORE, A STENT (4.5 X 3 NEUROFORM ATLAS / STRYKER) WAS PLACED TO LOCK COIL AND THE PROCEDURE WAS COMPLETED." FOLLOW UP (08-DEC-2020): "THE STENT HAD BEEN POSITIONED TO COVER THE ANEURYSM FROM THE BEGINNING. AFTER THAT, THE COIL PLACEMENT WAS STARTED. PATIENT'S VESSEL CONDITION: NO TORTUOUS WAS OBSERVED. AFTER THE COIL WAS PULLED BACK ONCE AND THE COIL INSERTED ABOUT 1LOOPS, THE DOCTOR SAID THAT THE COIL SUDDENLY STOPPED MOVING. AND WHEN THE COIL INSERTED ABOUT 2~3 LOOPS, THE COIL WAS EARLY DETACHED." FOLLOW UP (27-JAN-2021): FOR COMPLAINT (B)(4), WAS THE STENT PLACED BEFORE THE COILING OR WAS PLACED AFTER THE INCIDENT? I DID A FOLLOW UP AND WAS TOLD IT WAS PLACED BEFORE THE COILING BEGAN. "A TOTAL OF TWO STENTS WERE PLACED IN THE PATIENT. (THE FIRST STENT W

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11243948 ↗

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-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.