Prestige Coil System PRES0310CXPPLTRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00810068567403), received between Nov 3, 2023 and Nov 3, 2023 — 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.

• MalfunctionNov 3, 2023Migration; Migration

  IT WAS REPORTED THAT: "THE COIL WAS INPLANTED IN PULMONARY ARTERY AND ONCE DETACHED IT FLEW OUT OF PLACE. THE COIL HAD TO BE SNARED AND REMOVED FROM THE PATIENT. WE BELIEVE THAT THE PUSHING WIRE AFTER DETACHMENT GRABBED THE COIL PACK AND HELP DISLODGE THE COIL FROM PLACEMENT. WAS INDICATED THAT "TREAD TECH" IS NEEDED ON THE 3MM COILS FOR BETTER GRIPPING OF THE VESSEL." INCIDENT REPORT FORM SUBMITTED FOR THIS COMPLAINT INDICATES THAT NO PATIENT INJURY WAS SUSTAINED. (B)(6) 2023, ADDITIONAL INFORMATION PROVIDED BY ISSUER. "DID THE IMPLANT COMPLETELY MIGRATE OUT OF THE TREATMENT SITE OR DID A SEGMENT OF THE IMPLANT HERNIATE INTO THE PARENT VESSEL? THE ENTIRE COIL MIGRATED. IS MY UNDERSTANDING CORRECT: THE DELIVERY PUSHER INTERACTED WITH THE COIL MASS AFTER A SUCCESSFUL DETACHMENT, CAUSING THE IMPLANT TO MOVE OUT OF THE TREATMENT SITE? THAT IS CURRENT BELIEF."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18066316 ↗

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