Optima Coil System OPTI1650CSFMXRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00818053025341), received between Apr 16, 2026 and Apr 16, 2026 — classified as 1 malfunction.

The most frequently reported specific device problem is “Premature Separation” (1 report).

2 FDA recall records name this device's identifier, 2 still open.

3 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. 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 16, 2026Premature Separation

  IT WAS REPORTED THAT: "DURING A COIL EMBOLIZATION OF A SPINAL AVM, THE PHYSICIAN ATTEMPTED TO DEPLOY AN OPTIMA COMPLEX-18 (20 × 65) AS THE SEVENTH COIL THROUGH A HEADWAY 27 MICROCATHETER. DURING DEPLOYMENT, WHILE ATTEMPTING TO REPOSITION, HE REPORTED FEELING A "POP" AND SUBSEQUENTLY LOST ONE-TO-ONE CONTROL OF THE COIL. MULTIPLE ATTEMPTS WERE MADE USING DIFFERENT GUIDEWIRES AND COIL PUSHERS TO ADVANCE THE REMAINING PORTION OF THE COIL OUT OF THE MICROCATHETER; HOWEVER, THESE ATTEMPTS WERE UNSUCCESSFUL. THE COIL WAS ULTIMATELY UNINTENTIONALLY SNARED BY A COIL PUSHER WITHIN THE MICROCATHETER, AND THE PHYSICIAN WAS ABLE TO SUCCESSFULLY REMOVE BOTH THE COIL AND MICROCATHETER. AFTER RE-ACCESSING WITH A HEADWAY DUO 156 CM MICROCATHETER, THE PHYSICIAN PROCEEDED WITH ADDITIONAL COIL DEPLOYMENT. DURING PLACEMENT OF AN OPTIMAX SOFT (16 × 50), HE AGAIN EXPERIENCED LOSS OF ONE-TO-ONE CONTROL, AND THE COIL WAS PREMATURELY DETACHED WITH GREATER THAN 50% OF THE COIL REMAINING WITHIN THE MICROCATHETER. ATTEMPTS TO ADVANCE THE COIL USING GUIDEWIRES WERE UNSUCCESSFUL. A SYRINGE WAS THEN ATTACHED TO THE HUB, AND NEGATIVE PRESSURE WAS APPLIED WHILE WITHDRAWING THE MICROCATHETER, RESULTING IN SUCCESSFUL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24899848 ↗

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-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