Prestige Coil System PRES1865CPKPLTRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00810068567793), received between Mar 20, 2024 and Sep 11, 2024 — 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.

• MalfunctionSep 11, 2024Stretched; Migration; Stretched; Migration

  IT WAS REPORTED THAT: "WE ARE STILL FINDING OUT INFORMATION ABOUT THE CASE BUT HERE IS WHAT IS KNOWN: THE PHYSICIAN WAS USING A BSC RENEGADE MICROCATHTER AND A PRESTIGE PLUS COIL WAS DEPLOYED AND UPON REMOVAL OF THE PUSHER WIRE A STRING OF COIL CAME BACK WITH THE PUSHER. HE SPENT 2-3 HOURS SNARING THE BROKEN COIL FROM THE PATIENT WITH NO HARM. UPDATE 17SEP2024 - ADDITIONAL INFORMATION RECEIVED FROM THE ISSUER: "2ND CASE PORTAL VEIN EMBOLIZATION WITH EXTREME TORTUOSITY. MICROCATHETER USED WAS A BOSTON SCIENTIFIC STC DAMAGED COIL PRES1865CPKPLT LOT#F230900859. HE ADVANCED THE COIL INTO THE ABNORMAL VENOUS SHUNT THAT WAS MEASURING AROUND 15MM CROSS SECTIONAL. HE STATED THAT NOT ALL OF THE COIL MADE IT INTO THE SAC AS HE FELT RESISTANCE. WE DID NOT DETERMINE HOW MUCH OF THE 65CM MADE IT INTO THE SAC BUT HE DECIDED TO DETACH THE COIL AND THOUGHT HE WOULD SQUIRT THE REST OUT. HE HAD PROBLEMS REMOVING THE PUSHER ALMOST LIKE IT WAS "STUCK" THEREFORE HE DECIDED TO REMOVE THE PUSHER WITH THE MICROCATHETER. AS BACK OUT THE MICROCATHETER THE COIL ELONGATED AND FOLLOWED EVENTUALLY SQUIRTING OUT AND STAYING IN THE VESSEL HOWEVER NOT IN THE TARGET ZONE. WAS THE CATHETER WAS OUT HE REMOVED THE PUS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20196273 ↗
• MalfunctionMar 20, 2024Migration; Premature Separation; Migration; Premature Separation

  IT WAS REPORTED THAT: "WHEN PLACING THE 7TH COIL IN A SPLENIC ARTERY ANEURYSM (18X65), THE COIL BACKED OUT OF THE ANEURYSM AND BEGAN COILING IN THE INFLOW VESSEL. THE PHYSICIAN CONTINUED TO ADVANCE THE COIL INTO THE VESSEL, BUT THEN DECIDED TO PULL THE COIL BACK INTO THE MICROCATHETER (PROGREAT ALPHA 2.8->2.0) AND TRY TO REGAIN ACCESS INTO THE ANEURYSM TO FINISH PACKING IT. WHEN THE PHYSICIAN WAS RETRACTING THE COIL, HE ANNOUNCED THAT IT WAS NO LONGER ATTACHED. HE THEN TRIED TO SNARE THE COIL AND IT BROKE, DISTAL TO THE CATHETER IN THE SPLENTIC. HE THEN BEGAN TO PULL THE WINDING OF THE COIL. WE TRIED FOR HOURS TO SNARE." INCIDENT REPORT FORM SUBMITTED FOR THIS COMPLAINT INDICATES THAT NO PATIENT INJURY WAS SUSTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18942032 ↗

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