Prestige Coil System PRES0156CXPPLTRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00810068567328), received between Dec 12, 2024 and Dec 12, 2024 — classified as 1 malfunction.

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

2 other recalls 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.

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 12, 2024Migration; Premature Separation; Migration; Premature Separation

  IT WAS REPORTED THAT: "THE PHYSICIAN WAS PERFORMING A FONTAN EMBOLIZATION USING A 2.4 PROGREAT MICROCATHETER AND THE 1.5 X 6CM COIL WAS ABOUT 80% OUT WHEN IT BALLED UP IN THE DISTAL TIP. HE PULLED THE MICROCATHETER BACK INTO THE 4F GLIDECATH TO HAVE THE COIL UNLODGE BUT THEN PROLAPSED INSIDE THE 4F GLIDECATH. AFTER WIRE MANIPULATION AND PUSHING THE COIL FINALL POPPED OUT TO TRAVEL INTO A SIDE BRANCH LEAVING A LONG TAIL. HE FINALLY COILED THAT BRANCH AND WAS ABLE TO JAIL THE COIL SO IT WOULD NOT MOVE. HE SAID THE COIL GOT STUCK IN THE MICRO AND HE SHOULD HAVE FLUSHED IT OUT FIRST BEFORE PULLING THE MICRO INTO THE GLIDECATH." UPDATE 15NOV2024 - ADDITIONAL INFORMATION RECEIVED FROM THE ISSUER: "PATIENT IS SATISFACTORY AND WAS DISCHARGED." INCIDENT REPORT FORM SUBMITTED FOR THIS COMPLAINT INDICATES THAT NO PATIENT INJURY WAS SUSTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20914344 ↗

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-1989-2025 · May 8, 2025 · Open, Classified
  Prestige Coil System REFs/UDI-DI codes: PRES0153CXPPLT 00810068567311 PRES1045CPKPLT 00810068567663 PRES1245CPKPLT 00810068567694 PRES1445CPKPLT 00810068567724 PRES0103CXPPLT 00810
• 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