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Optima Coil System OPTI0620CST10 (REF N/A)Recalls & reported problems

Balt USA LLC · The Optima Coil System is indicated for endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations (AVMs) and arteriovenous fistulae. The Optima Coil System is also indicated for vascular occlusion of blood vessels within the neurovascular system to permanently obstruct blood flow to an aneurysm or other vascular malformation and for arterial and venous embolization in the peripheral vasculature. The Optima Coil System comprises of implant coil and a pusher assembly. The Optima Coil System is designed fr use with the XCEL Detachment Controller. The Optima coil is detached thermally with the XCEL Detachment Controller. · Class 2 · Implant

Data updated Oct 13, 2026 from official FDA records · Editorial policy

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports
2
Deaths reported
0
Injuries reported
1
Recalls naming it
1

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00818053021848), received between Apr 1, 2019 and Apr 18, 2019 — classified as 1 injury, 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

Device problems

  • Detachment of Device or Device Component1
  • Difficult or Delayed Positioning1
  • Difficult to Remove1
  • Entrapment of Device1

Patient problems

  • Aneurysm2
  • Patient Problem/Medical Problem2

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • MalfunctionApr 18, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

    IT WAS REPORTED THAT: "61-YEAR-OLD PATIENT, HOSPITALIZED FOR BLEEDING UNDER ARACHNOID. DURING THE EMBOLIZATION PROCEDURE, THE SURGEON NOTED THE UNINTENDED DETACHMENT OF A COIL BEING DEPLOYED WHILE HALF WAS ALREADY POSITIONED AND BLOCKED IN THE MESH OF THE PREVIOUS COIL. ATTEMPT TO RECOVER THE FLOATING COIL AND BURIAL IN THE EXTERNAL CAROTID. THE COIL WILL FINALLY BE LEFT IN PLACE IN THE ANEURYSM SAC."

    Patient problems: Aneurysm; Patient Problem/Medical Problem

    MAUDE report 8529824 ↗
  • InjuryApr 1, 2019Difficult or Delayed Positioning; Entrapment of Device; Difficult to Remove; Difficult or Delayed Positioning; Entrapment of Device; Difficult to Remove

    IT WAS REPORTED THAT: "TREATMENT OF A RUPTURED LEFT SYLVIAN BIFURCATION ANEURYSM: A FIRST OPTIMA COIL WAS INSERTED THROUGH AN ECHELON 14, 45 DEGREES WITHOUT ANY PROBLEMS (OPTI0724CST10, LOT 072518A-050). A SECOND COIL OPTI0620CST10 WAS POSITIONED INTO THE ANEURYSM. WHILE REPOSITIONING THE COIL BY RESHEATHING HIM, THE COIL DETACHED SPONTANEOUSLY IN THE CATHETER. ONE PART OF THE COILS WAS TRAPPED IN THE ANEURYSM BY THE FIRST COIL AND THE OTHER PART FLOATED INTO THE ECHELON... THE END OF THE PROCEDURE WAS EXTREMELY CHALLENGING BECAUSE THE PROXIMAL PART OF THE COIL MIGRATE IN AN UPPER BRANCH AND STARTED TO CLOSE IT. THE DR TRIED TO CAPTURE THE COIL WITH A LASSO BUT IT WAS IMPOSSIBLE AND HE STRETCHED THE COIL. AT THE END, THE PROXIMAL PART OF THE STRETCHED COIL WAS REMOVED FROM THE UPPER BRANCH AND PLACED IN THE EXTERNAL CAROTID WITH A SCEPTER C BALLOON, WHERE IT WAS LESS DANGEROUS FOR THE PATIENT."

    Patient problems: Aneurysm; Patient Problem/Medical Problem

    MAUDE report 8469385 ↗

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.

Other Device, Neurovascular Embolization devices

All Device, Neurovascular Embolization devices →

Sources and updates

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