Prestige Coil System PRES0410CPKPLTRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00810068567465), received between Nov 1, 2024 and Jul 23, 2025 — classified as 2 malfunctions.

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

• MalfunctionJul 23, 2025Premature Separation; Premature Separation

  IT WAS REPORTED THAT: "THE PHYSICIAN WAS PERFORMING AN EMBOLIZATION FOR AN ADBDOMEN HEMORRAGE AND WAS USING A PROGREAT 2.4F MICROCATHETER. SHE WENT TO REPOSITION THE CATHETER AND THE COIL BROKE WITHOUT MUCH TENSION. SHE HAD TO LOSE ACCESS SINCE THE COIL WAS COMPROMISED. THE COIL CAN BE RETURNED FOR INSPECTION." INCIDENT REPORT FORM SUBMITTED FOR THIS COMPLAINT INDICATES THAT NO PATIENT INJURY WAS SUSTAINED. UPDATE - ADDITIONAL INFORMATION RECEIVED FROM THE ISSUER ON 23JUN2025: "1. DID THE PROCEDURE INVOLVE TORTUOUS ANATOMY? MILD TORTUOUSITY. 2. WILL THE MICROCATHETER BE AVAILABLE FOR RETURN? NO . 3. WHERE DID THE IMPLANT PREMATURELY DETACH? (INSIDE THE AN, INSIDE THE MC? ETC) THE COIL WAS IN THE PATIENT AND HALFWAY STILL IN THE MICROCATHETER. 4. WERE ANY ATTEMPTS MADE TO DETACH THE IMPLANT COIL USING THE DETACHMENT CONTROLLER? NO. 5. CAN YOU CONFIRM IF THE DEVICE WAS IMPLANTED? DEVICE WAS REMOVED FROM PATIENT".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22583429 ↗
• MalfunctionNov 1, 2024Premature Separation; Premature Separation

  IT WAS REPORTED THAT: "THE PHYSICIAN DECIDED TO USE A TRUSELECT 2.0F MICROCATHETER TO COIL THE OUTFLOW OF A RENAL ANEURYSM. SHE SELECTED A 4X10 PRESTIGE PLUS COIL FROM THE JACKSON CONSIGNMENT. THE SHEATH CAME OFF THE COIL AND SHE BEGAN ADVANCING WHEN SHE FELT RESISTANCE, SHE PUSHED THROUGH SLIGHTLY AND THE COIL SEEMED TO LOOP AS IF THE FRONT END WAS STUCK AND THE BACK END WAS STILL ATTACHED TO THE PUSHER COIL. THE COIL THEN BROKE OFF BUT THE TREAD PART OF THE 4X10 STAYED LODGED IN THE MICROCATHETER. THIS LED TO PRE DETACHMENT AND NEED FOR COMPLETELY NEW ACCESS. AFTER REPLACING THE MICROCATHETER, SHE SNARED THE REST OF THE COIL OUT OF THE VESSEL AND PROCEEDED TO USE PENUMBRA (8 COILS) FOR THE REMAINDER OF THE CASE." INCIDENT REPORT FORM SUBMITTED FOR THIS COMPLAINT INDICATES THAT NO PATIENT INJURY WAS SUSTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20588447 ↗

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