Prestige Coil System PRES1465CPKPLTRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00810068567731), received between Dec 13, 2023 and Apr 11, 2025 — classified as 2 malfunctions.

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

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

• MalfunctionApr 11, 2025Stretched; Premature Separation; Stretched; Premature Separation

  IT WAS REPORTED THAT: "WHILE DELIVERING THE COIL, THE PHYSICIAN TRIED TO RETRACT THE COIL TO REPOSITION. IT GOT STUCK. IT DETACHED STILL PARTIALLY IN THE MICROCATHETER. WHEN THE PHYSICIAN TRIED TO SNARE THE COIL, IT BEGAN TO UNRAVEL. ULTIMATELY, IT WAS ALL REMOVED. I HAVE THE COIL AND CATHETER FOR RETURN." INCIDENT REPORT FORM SUBMITTED FOR THIS COMPLAINT INDICATES THAT NO PATIENT INJURY WAS SUSTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21831220 ↗
• MalfunctionDec 13, 2023Premature Separation; Premature Separation

  IT WAS REPORTED THAT: "DURING AN ENDOLEAK THIS WAS THE 5TH COIL BEING DEPLOYED THROUGH A PROGREAT 2.4F MICROCATHETER. THE PHYSICIAN WAS ADVANCING THE COIL INTO THE COIL PACK AND DECIDED TO REPOSITION SINCE HE FELT RESISTANCE BEING MET BY THE COIL PACK. WHEN HE GENTLY PULLED THE COIL BACK HE FELT A POP AND THE COIL DETACHED FROM THE COIL PUSHER. HE TRIED TO SNARE THE COIL BUT ENDED UP BREAKING THE COIL IN HALF AS IT WOULD NOT RELEASE FROM THE COIL PACK. HE LEFT THE REMAINING COIL IN THE PATIENT AS IT WAS SECURE AND NOT COMING LOOSE." INCIDENT REPORT FORM SUBMITTED FOR THIS COMPLAINT INDICATES THAT NO PATIENT INJURY WAS SUSTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18318880 ↗

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