Prestige Coil System PRES3530CXPPLTRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00810068567458), received between Sep 20, 2023 and Nov 20, 2024 — classified as 2 malfunctions.

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

• MalfunctionNov 20, 2024Premature Separation; Premature Separation

  IT WAS REPORTED THAT: "THE PHYSICIAN WAS ADVANCING THE THIRD COIL OF THE CASE AND IT BECAME STUCK IN THE MICRO-CATHETER WHEN TRYING TO PULL BACK THE COIL PUSHER BROKE IN THE VESSEL. THE PHYSICIAN THEN USED SALINE TO FORCE THE REST OF THE COIL IMPLANT INTO THE VESSEL BUT THE PUSHER BROKEN PART WAS NOT ABLE TO BE DISLODGED." INCIDENT REPORT FORM SUBMITTED FOR THIS COMPLAINT INDICATES THAT NO PATIENT INJURY WAS SUSTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20735789 ↗
• MalfunctionSep 20, 2023Separation Problem; Separation Problem

  IT WAS REPORTED THAT: "DEVICE WAS BEING UTILIZED AND WOULD NOT DEPLOY. DEVICE WAS THEN REMOVED BUT COIL BROKE WHILE BEING REMOVED GI BLEED NO LOCATION GIVEN, PRODUCT NEVER GOT OUT OF SHEATH. PRODUCT WAS TESTED BEFORE INTRODUCED INTO PATIENT." INCIDENT REPORT FORM SUBMITTED FOR THIS COMPLAINT INDICATES THAT NO PATIENT INJURY WAS SUSTAINED. "BROKE INSIDE OF THE PATIENT AND DOCTOR WAS ABLE TO PUSH INTO PLACE WAS DURING A GI BLEED, COILS WAS NOT CAUSE OF THE BLEED".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17786268 ↗

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