Optima Coil System OPTI0253CSS10 (REF N/A)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00818053025839), received between Mar 15, 2024 and Mar 15, 2024 — classified as 1 injury.

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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 · Recall details · 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.

• InjuryMar 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT: "IT WAS A CASE OF RUPTURED ANEURYSM AT THE ORIGIN OF PICA MEASURING 3MMX2.5MM WITH A NECK OF 2.31MM. THE PHYSICAN PLANNED TO DO SIMPLE COILING.THE SUPPORT SYSTEM WAS BALLAST 80CMS AND FARGOMAX 6F 105, THE VASCO 10 MP WAS PLACED INSIDE THE ANEURYSM WITH SUPPORT OF HYBRID 12/14 DA. VASCO 10 MP WAS CONNECTED WITH A FLUSH LINE. THE FIRST COIL BARRICADE COMPLEX FRAME 2.5*5 WAS PREPARED AS PER IFU AND THEN ALIGNED TO THE HUB OF THE MICRO CATHETER. ON PUSHING THE COIL THERE WAS RESISTANCE FELT INSIDE THE MICRO AND UPON RESHEATHING TO CHECK IT WAS FOUND THAT THE COIL WAS COMING OUT STRECHED.THE COIL WAS REMOVED AND THE NEXT COIL WAS OPTIMA COMPLEX 10 SOFT 2.5*5 AND THE COIL WAS PREPARED AS PER IFU AND ALIGNED TO THE HUB OF THE MICRO AND COIL BEING PUSHED THE INITIAL COIL WENT IN SMOOTH TILL THE TIME THAT THE FLUROSAFE MARKERS WERE ENTERING THE PROXIMAL PART OF THE SLEEVE RESISTANCE WAS FELT ,UPON RESHEATHING IT WAS NOTICED THAT THE COIL SHAPE HAD CHANGED AND SOME KINKS SEENS IN THE DELIVERY SYSTEM.THE PHYSCIAN CHOOSE OPTIMA COMPLEX 10 SUPER SOFT 2.5*3 AND PREPARED THE COIL AS PER IFU AND THE COIL IN THE SAME MICRO WENT IN WITHOUT ANY ISSUES BUT ONCE THE COIL CAME OUT

  Patient problems: Rupture

  MAUDE report 18912479 ↗

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.