Prestige Coil System PRES0635CPKPLTRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00810068567564), received between Jul 23, 2024 and Feb 7, 2025 — classified as 2 malfunctions.

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

• MalfunctionFeb 7, 2025Premature Separation; Premature Separation

  IT WAS REPORTED THAT: "THE PHYSICIAN PERFORMING A BRONCHIAL AVM WITH A RENEGADE 18 MICROCATHETER 150CM WITH A BASE 5F DIAGNOSTIC CATHETER. USED ONE PRESTIGE 6X15 LE COIL WITH NO ISSUES AND WAS DEPLOYED WITHOUT ISSUE. GRABBED 1 6X35 PRESTIGE LE AND AS THE COIL ADVANCED HE SAID IT WAS GETTING HARDER TO PUSH THAT WAS RIGHT AFTER HE STEPPED ON FLURO AS THE FLURO SAVE MARKER PASSED BY. HE TRIED TO REPOSITION AND SAID THAT IT LOOKED LIKED TO PRE-DETACHED. HE GRABBED A 1CM SYRINGE TO SQUIRT THE COIL AND IT APPEARED IT WENT INTO THE COIL MASS WITHOUT ISSUE. HE GRABBED 1 MORE 6X35 PRESTIGE LE AND THIS TIME AS HE ADVANCED IT WOULD NOT ADVANCE AS THERE WAS COIL FROM THE 1ST 6X35 COIL IN THE MICROCATHETER BECAUSE THE COIL BROKE AND WAS IN A RATS NEST OF INNER COIL. HE HAD TO LOSE ACCESS AND ABORT THE CASE." UPDATE 10JAN2024 - ADDITIONAL INFORMATION RECEIVED FROM THE ISSUER: "1. HOW WOULD THE TORTUOSITY BE DESCRIBED IN THIS PROCEDURE? SEE ATTACHED PHOTOS IT WAS VERY TORTUOUS. 2. FOR COMPLAINT (B)(4), ARE WE ALSO RECEIVING THIS UNIT? NOT SURE WHY THERE ARE TWO COMPLAINTS AS IT WAS ONE CASE. I AM SENDING BACK THE RENEGADE 18 AND THE 6X15 PUSHER AND THE 6X35 PUSHER WITH NO COILS AS THEY ARE IN THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21334321 ↗
• MalfunctionJul 23, 2024Migration; Migration

  IT WAS REPORTED THAT: "ATTEMPTED TO DEPLOY COIL BUT COULDN'T BECAUSE IT WAS ALREADY PARTIALLY DEPLOYED. PRESTIGE COIL SYSTEM, BALT, F240300091." UPDATE 01JUL2024 - ADDITIONAL INFORMATION RECEIVED FROM THE ISSUER: "1. CAN YOU PROVIDE A BIT MORE INFORMATION REGARDING WHAT HAPPENED? (WHAT DO YOU MEAN BY DEPLOYED?) IT WAS ALREADY PARTIALLY DEPLOYED 2. DID THE INCIDENT CAUSE PATIENT INJURY? NO INJURY"

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19806314 ↗

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