Prestige Coil System PRES0320CXPPLTRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00810068567410), received between Nov 17, 2023 and Nov 27, 2024 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Premature Separation” (2 reports).

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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 · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 27, 2024Premature Separation; Premature Separation

  IT WAS REPORTED THAT: "I WAS EMBOLIZING THE GASTRODUODENAL ARTERY WITH ACTIVE BLEEDING. THE PATIENT WAS IN A SERIOUS CONDITION, WITH THE HEPATIC ARTERY ORIGINATING ISOLATED FROM THE AORTA AND IN SPASM, MAKING IT DIFFICULT TO STABILIZE THE 5F CATHETER. I PLACED THE FIRST COIL, AND EVERYTHING WENT SMOOTHLY. I TOOK THE SECOND, LONGER ONE TO CLOSE IT QUICKLY, AND IT THREW THE MICROCATHETER OUT OF THE GDA. I REPOSITIONED IT AND CONTINUED TO INSERT THE COIL. AFTER ABOUT THREE REPOSITIONING'S, THE COIL WAS COMPLETELY DETACHED WITH ABOUT 70% IN THE VESSEL AND 30% INSIDE THE PROGREAT MICROCATHETER. GIVEN THE PATIENT'S SERIOUS CONDITION, I PUSHED IT WITH SALINE." INCIDENT REPORT FORM SUBMITTED FOR THIS COMPLAINT INDICATES THAT NO PATIENT INJURY WAS SUSTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20798336 ↗
• MalfunctionOct 16, 2024Stretched; Stretched

  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 GOT STUCK INSIDE THE CATHTER. HE WAS NOT ABLE TO REMOVE THE COIL OR ADVANCE SO CATHETER WAS REMOVED. " UPDATE 17SEP2024 - ADDITIONAL INFORMATION RECEIVED FROM THE ISSUER: "1ST CASE INFERIOR MESENTERIC ARTERY EMBOLIZATION MICROCATHETER USED WAS A BOSTON SCIENTIFIC STC PRES0320CXPPLT LOT#F240300154 THE PHYSICIAN STATED THAT HE HAD TO REPOSITION THE COIL 4-5 TIMES IN ORDER FOR PROPER PLACEMENT. HE DID NOT FEEL ANY SIGNIFICANT RESISTANCE HOWEVER ONCE HE DEPLOYED THE COIL AND UPON REMOVAL OF THE STC CATHETER HE NOTICED THE THIN FILAMENT COMING OUT OF THE MICROCATHETER. HE HAD TO MAGNIFY UP TO GET A BETTER VISUAL AND PROCEED TO SNARE THE COIL FOR 2 HOURS UNTIL IT WAS FULLY RETRIEVED FROM THE PATIENT." INCIDENT REPORT FORM SUBMITTED FOR THIS COMPLAINT INDICATES THAT NO PATIENT INJURY WAS SUSTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20464784 ↗
• MalfunctionNov 17, 2023Premature Separation; Premature Separation

  IT WAS REPORTED THAT: "DR. (B)(6) WAS PERFORMING A Y90 TREATMENT. UNDER FLUOROSCOPIC IMAGING THERE WERE VESSELS DISTAL TO THE TREATMENT SEGMENT THAT HE WANTED TO COIL TO PREVENT NON TARGET EMBOLIZATION. HE DECIDED TO USE A 3MM X 20CM PRESTIGE PLUS COMPLEX COIL. ANGIOGRAPHY SHOWED NORMAL ANATOMY. HE USED A 2.4FR TERUMO PROGREAT MC TO GET TO WHERE HE WANTED. HE INSERTED THE COIL INTO THE MC WITH NO RESISTANCE IN DELIVERING THE COIL THROUGH THE MC. AS THE COIL WAS GETTING TO THE DESIRED AREA AND ABOUT À OF THE COIL WAS OUT OF THE TIP OF THE MC, DR. (B)(6) HAD GENTLY PULLED BACK TO ADJUST HIS COIL. THIS IS WHERE THE COIL PREDETACHED FROM THE PUSHER DELIVERY SYSTEM. DR. (B)(6) THEN HAD TO "PUSH" OUT THE COIL BY INJECTING SALINE SOLUTION THROUGH A SYRINGE. THE COIL WAS IMPLANTED, HOWEVER IT BLOCKED (JAILED OFF) THE VESSEL THAT HE WANTED TO TARGET FOR CHEMO THERAPY." INCIDENT REPORT FORM SUBMITTED FOR THIS EVENT INDICATED NO PATIENT INJURY WAS SUSTAINED AS A RESULT OF THIS INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18165453 ↗

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