Optima Coil System OPTI2065COM18 (REF N/A)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00818053026546), received between Dec 21, 2023 and Apr 16, 2026 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Premature Separation” (3 reports).

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 3 most recent of 3 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 24905277 ↗
• MalfunctionApr 26, 2024Premature Separation; Premature Separation

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19192416 ↗
• MalfunctionDec 21, 2023Premature Separation; Premature Separation

  IT WAS REPORTED THAT: "IT WAS A CASE OF DIRECT CCF THE PHYSICAN PLANNED TO DO COILING AND EMBOLISATION WITH BALLON ASSISTING. THE SUPPORT SYSTEM WAS NEUROMAX AND NAVIEN072, THE ECHELON10 WAS PLACED INSIDE THE RENT WITH SUPPORT OF HYBRID1214D. THE ECHELON10 WAS CONNECTED WITH A FLUSH LINE. THE COIL WAS PREPARED AS PER IFU AND THEN ALIGNED TO THE HUB OF THE MICRO CATHETER, THE FIRST COIL SIZE OF 24*65 OPTIMA COMPLEX18 WAS TAKEN ON INTRODUZING, THE COIL WENT SMOOTHLY THROUGH THE SLEEVE INTO THE HUB OF ECHELON10 AND DETACHED LATER TOOK 22MM*65MM OPTIMA COMPLEX18 AND DETACHED NEXT PHYSICIAN TOOK 20MM*65MM OPTIMA COMPLEX18 THE COIL WENT SMOOTHLY THROUGH THE SLEEVE INTO THE HUB. PHYSICIAN WAS PUSHING THE COIL INTO THE RENT BUT THE COIL WAS NOT MOVING LATER PHYSICIAN WAS RETERVING COIL BUT NO MOVEMENT WAS HAPPENING. COIL HAD PRE-DETACHED BUT THE COIL WAS REMOVED WITH THE HELP OF CATCHMAXI40 COIL BEEN TAKEN OUT AND PHYSICIAN DECIDED TO INJECT SQUID WITH THE INFLATION OF COPERNIC 5*20 CASE WAS COMPLETED WITHOUT ISSUE." INCIDENT REPORT FORM SUBMITTED FOR THIS COMPLAINT INDICATES THAT NO PATIENT INJURY WAS SUSTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18374632 ↗

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.