Skip to content

Prestige Coil System PRES0204CXPPLRecalls & 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

2 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.

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

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

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

5 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-1989-2025 · 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-1042-2024 · Root cause: Material/Component Contamination · FDA record ↗

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-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.
  • 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

Other Device, Vascular, For Promoting Embolization devices

All Device, Vascular, For Promoting Embolization devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.