Prestige Coil System PRES0865HPKPLRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00810068567878), received between Jul 5, 2024 and Jul 5, 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.

• MalfunctionJul 5, 2024Stretched; Migration; Premature Separation; Stretched; Migration; Premature Separation

  IT WAS REPORTED THAT: "HI TEAM, CAN YOU PLEASE REPLACE THE PRES0865HPKPL TO ACCOUNT. WE HAD A COIL BREAK AND STRETCH IN A TORTOUS SPLENIC ANEUYRSM. I WILL SEND PICS OF ANATOMY AS WELL. PLACED 3 COILS PRIOR TO PLACING THE 8X65 THE COIL. THE COIL WAS ROUGHLY 5CM INTO ANEUYRSM DOCTOR FELT FRICTION DECIDED TO PULL BACK AND RESHEATH AND COIL BROKE AND STRETCHED. WE SPENT 2.5 HOURS TRYING TO RETRIEVE COIL WAS ABLE TO GET ALL OF FILAR OUT BUT HAD TO LEAVE A LOOSE PORTION OF COIL IN SPLENIC. THIS IS THE 11TH COMPLAINT OF THE YEAR WITH THIS ONE ACCOUNT. I DID 10-11 COMPLAINTS IN ALL OF 2023, THERE SEEMS TO BE ON GOING ISSUES WITH THE PRESTIGE COILS." UPDATE 07JUN2024 - ADDITIONAL INFORMATION RECEIVED FROM THE ISSUER: "1. DID THE PROCEDURE INVOLVE TORTUOUS ANATOMY? - ANATOMY WAS TORTUOUS AT SITE FOR EMOBIZATION, THE COIL BROKE AT PROXIMAL END AS IT WAS BEING INTRODUCED. 2. CAN YOU CONFIRM IF THERE WERE ANY ATTEMPTS MADE TO DETACH THE IMPLANT COIL USING THE DETACHMENT CONTROLLER? NO ATTEMPTS TO DETACH WERE MADE IT SIMPLY BROKE AND UNRAVELED." INCIDENT REPORT FORM SUBMITTED FOR THIS COMPLAINT INDICATES THAT NO PATIENT INJURY WAS SUSTAINED. UPDATE 21JUN2024 - ADDITIONAL INFORMATION RECEIVED FRO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19680700 ↗

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