Prestige Coil System PRES0420CPKPLTRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00810068567489), received between Dec 11, 2024 and Dec 11, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Migration” (1 report).

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. 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 ↗

Most reported problems

Recent adverse event reports

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

• MalfunctionDec 11, 2024Migration; Premature Separation; Migration; Premature Separation

  IT WAS REPORTED THAT: "I WAS NOT IN THIS PROCEDURE AS THIS WAS PERFORMED LATE FRIDAY EVENING. I RECEIVED A PHONE CALL FROM THE PHYSICIAN IN THE MIDDLE OF THIS PROCEDURE. HE WAS PERFORMING A GDA EMBOLIZATION. HE WAS USING A 2.4FR PROGREAT MC AND HAD DEPLOYED A FEW OTHER PRESTIGE COILS IN THIS PROCEDURE PRIOR TO THIS INCIDENT. HE NOTED THAT HE DID NOT EXPERIENCE ANY HEAVY RESISTANCE AND THAT THE ANATOMY WAS NOT TORTUOUS HE NOTD THAT AS HE WAS PULLING BACK THE COIL TO ADJUST, IT HAD PRE-DETACHED.THE DISTAL PART OF THE COIL WAS IN THE GDA AND THE MAJORITY OF THE COIL WAS IN THE MC. HE THEN TRIED TO PUSH IT OUT, UNFORTUNATELY IT DID NOT PACK WELL AND THE PROXIMAL END OF THE COIL STARTED TO MOVE TO THE PROPER HEPATIC ARTERY AND INTO A BRANCH OFF OF THE PROPER HEPATIC." INCIDENT REPORT FORM SUBMITTED FOR THIS COMPLAINT INDICATES THAT NO PATIENT INJURY WAS SUSTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20903593 ↗

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