Prestige Coil System PRES0865CPKPLTRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00810068567632), received between Jun 12, 2024 and May 9, 2025 — classified as 2 malfunctions.

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

• MalfunctionMay 9, 2025Migration; Premature Separation; Migration; Premature Separation

  IT WAS REPORTED THAT: "PRES0865CPKPLT - IN A GONADAL CASE WITH DR (B)(6) ON (B)(6) 2025 WE USED SEVERAL PRESTIGE COILS. THE FINAL COIL THAT WE USED DEPLOYED EARLY IN THE 2.4 PROGREAT MICROCATHETER. IT SOUNDS LIKE DR (B)(6) AND THE IR TECH FELT SOME RESISTANCE DURING THE DEPLOYMENT. 70% OF THE COIL DEPLOYED CORRECTLY IN THE VESSEL BUT THE LAST 30% DEPLOYED EARLY AND DIDN'T COIL PROPERLY, THE END RESULT BEING A TAIL FLOATING IN THE RENAL VEIN ABOVE THE REST OF THE COILS IN THE GONADAL VEIN. DR (B)(6) TRIED TO PUSH THE TAIL OF THE COIL WITH A WIRE AND WITH A BALLOON BUT WAS UNABLE TO SUFFICIENTLY MOVE THE COIL. SHE FELT THAT THE COIL WAS SECURE ENOUGH AND WOULDN'T TRAVEL BECAUSE THE INITIAL 70% OF THAT COIL CORRECTLY DEPLOYED AND WAS SECURE." INCIDENT REPORT FORM SUBMITTED FOR THIS COMPLAINT INDICATES THAT NO PATIENT INJURY WAS SUSTAINED. UPDATE 11APR2025- ADDITIONAL INFORMATION RECEIVED FROM THE ISSUER: "1. ANY UPDATES ON THE PATIENT? - I REACHED OUT TO DR (B)(6) TODAY AND SHE SAID THE PATIENT WAS FINE WHEN THEY WENT HOME TUESDAY AND SHE HASN'T HEARD ANY NEWS FROM THE PATIENT SINCE THEN."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21998762 ↗
• MalfunctionJun 12, 2024Migration; Premature Separation; Migration; Premature Separation

  IT WAS REPORTED THAT: "WHILE ADVANCING THE SECOND COIL, AN 8X65, THROUGH A 2.8 PROGREAT THE FELLOW FELT RESISTANCE. THE STAFF DOCTOR SCRUBBED IN TO HELP AND TRIED TO ADVANCE THE COIL, THEN PULL BACK, AND THE COIL DETACHED IN THE MICROCATHETER. ENOUGH OF THE COIL WAS OUT OF THE CATHETER THAT THE PHYSICIAN WAS ABLE TO FLUSH THE REST OUT OF THE CATHETER INTO THE VESSEL WITH A SALINE SYRINGE." UPDATE 15MAY2024 - ADDITIONAL INFORMATION RECEIVED FROM THE ISSUER: "NO TORTUOUS ANATOMY, AND THE PROCEDURE WAS FINISHED WITH PENUMBRA COILS." INCIDENT REPORT FORM SUBMITTED FOR THIS COMPLAINT INDICATES THAT NO PATIENT INJURY WAS SUSTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19519359 ↗

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