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Optima Coil System PRES1447COM18Recalls & reported problems

Balt USA LLC · The Prestige Coil System is indicated for arterial and venous embolizations in the peripheral vasculature. It is designed for use with the Ultra 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
1
Deaths reported
0
Injuries reported
0
Recalls naming it
1

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00818053023248), received between May 19, 2021 and May 19, 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.

4 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-1042-2024 · Root cause: Material/Component Contamination · FDA record ↗

Most reported problems

Device problems

  • Detachment of Device or Device Component1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

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

  • MalfunctionMay 19, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

    IT WAS REPORTED THAT: "DOCTOR WAS PLACING SECOND COIL INTO THE ANEURYSM. MULITPLE LOOPS CAME OUT OF THE ANEURYSM WITH ABOUT 10CM LEFT. DOCTOR TRIED TO PULL BACK AND REPOSITION BUT COIL PREMATURELY DETACHED. LEAVING MULITPLE LOOPS OUT OF THE ANEURYSM AND A TAIL. DOCTOR HAD TO PLACE A STENT TO TACK DOWN THE EXPOSED LOOPS."

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11852157 ↗

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-1041-2024 · Jan 3, 2024 · Open, Classified
    Neurovascular embolization device. The Optima Coil System is a series specialized coils that are inserted into the vasculature under angiographic visualization to embolize intracra
  • 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, Vascular, For Promoting Embolization devices

All Device, Vascular, For Promoting Embolization devices →

Sources and updates

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