Prestige Coil System PRES0204CXPPLTRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00810068567342), received between Mar 16, 2023 and May 22, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Migration” (2 reports).

1 FDA recall record name this device's identifier, 1 still open.

1 other recall cover devices cleared under the same FDA submission (K220699); 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. May 8, 2025Class IIOpen, 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 · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

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

• MalfunctionMay 22, 2026Failure to Advance; Migration

  IT WAS REPORTED THAT: "THE PHYSICIAN WAS DOING A DISTAL SPLENIC EMBOLIZATION AT AROUND 1AM. SHE MENTIONS THAT THE ANATOMY TO GET TO THE BLEED WAS QUITE TORTUOUS. SHE WAS USING A 2.0FR PROGREAT MICROCATHETER. SHE HAD ALREADY USED SEVERAL PRESTIGE COILS UP TO THIS POINT WITH NO ISSUE. THE CURRENT PRODUCT SKU INCIDENT HAS NOTHING TO DO WITH THE COIL IMPLANT ITSELF BUT THE PUSHER. SHE DEPLOYED THIS 2MM X 4CM PRESTIGE PLUS COIL IN THE LAST VESSEL AND WHEN SHE WENT TO REMOVE THE PUSHER DELIVERY SYSTEM FROM THE MICROCATHETER SHE MET A LITTLE RESISTANCE FOLLOWED BY NO RESISTANCE AT ALL, THINKING THAT EVERYTHING WAS OK. SHE TRIED TO FLUSH THE MICROCATHETER WITH SALINE, SHE NOTICED THAT THERE WAS HEAVY RESISTANCE TRYING TO FLUSH IT, THINKING THAT MAYBE THE COIL MAY NOT HAVE BEEN FULLY DEPLOYED. SHE THEN LOOKED DID A LIVE FLUORO SHOT (NO CONTRAST) TO CONFIRM THAT THE COIL WAS FULLY REMOVED. SHE TRIED A SECOND TIME TO FLUSH THE MICROCATHETER WITH SALINE, USING A BIT MORE FORCE AND FELT THE MICROCATHETER CLEAR OUT. THE PHYSICIAN THEN DECIDED TO DO ONE MORE POST EMBOLIZATION CONTRAST RUN AND NOTICED WHAT LOOKED TO BE THE DISTAL PART OF THE PUSHER DELIVERY SYSTEM. SHE NOTES THAT THE RADIOPAQUE MA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25262096 ↗
• MalfunctionMar 16, 2023Migration; Premature Separation; Migration; Premature Separation

  IT WAS REPORTED THAT: "THE FIRST COIL, 2/4 REF #PRES0204CXPPLT LOT# F220701319. DETACHED FROM THE INTRODUCER WITHOUT THE DETACHMENT DEVICE AND CAUSED NON TARGET EMBO IN THE DISTAL RIGHT HEPATIC ARTERY AND COULDN'T BE RETRIEVED." UPDATE 03MAR2023: "THE FINAL OUTCOME OF THE CASE WAS SUCCESSFUL THERE WAS NO HARM TO THE PATIENT. THE MIGRATED COIL ACTUALLY SHUTDOWN THE VESSEL AND SHE WAS ABLE TO TREAT THE TARGET ZONE WITH PARTICLES. THE FIRST COIL THAT DETACHED WAS BECAUSE OF THE PACK AND IT KNOTTED UPON ITSELF. SHE THINKS WHEN SHE WENT TO REPOSITION THE COIL SHE DID NOT MOVE MC TO TAKE OUT THAT KNOT OUT AND THEREFORE THE COIL DETACHED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16554026 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K220699. One submission often covers many models, so check the product and lot details in each record.

• Z-1042-2024 · Jan 3, 2024 · Open, Classified
  The Prestige Coil System is a product family of embolic coils with associated delivery system components. These devices are angiographically delivered through the vasculature to em