Prestige Coil System PRES2265COM18Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00840303708124), received between Jul 31, 2026 and Jul 31, 2026 — classified as 1 injury.

The most frequently reported specific device problem is “Premature Separation” (1 report).

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. Jan 3, 2024Open, Classified

   Discoloration was identified along the delivery pusher which was attributed to corrosion of the hypotube. The material which caused the corrosion was identified as remnants of solder flux residue remaining on the hypotube component of the delivery pusher. Due to the location of the delivery pusher within the delivery system, it is possible for the discoloration to mechanically break off from the delivery pusher, leaving the potential for the material to flow through the delivery system (i.e. microcatheter), and into the patient vasculature causing foreign emboli.

   Z-1042-2024 · Root cause: Material/Component Contamination · Recall details · FDA record ↗

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.

• InjuryJul 31, 2026Premature Separation

  It was reported that:"During the procedure to place an endoprosthesis for a right common iliac artery aneurysm, the aneurysm was visualized via arteriography. Selective cannulation of the right iliac artery was performed using a guidewire; the catheter was not advanced further. VERT, Internal Mammary, and Simmons 1 catheters were used. Puncture of the left common femoral artery was performed, followed by placement of a Simmons catheter and cannulation of the contralateral right common iliac artery, without advancing the catheter into the right internal iliac artery. The 5Fr sheath in the right common femoral artery was exchanged for a long Sentran sheath. Two guidewires were passed through the Sentran sheath: a Lunderquist wire into the aorta and a hydrophilic wire into the aneurysm. A 5Fr catheter was placed over the hydrophilic wire, and a micro-guidewire and microcatheter were introduced through the 5Fr catheter. A Medtronic endoprosthesis was deployed, and the aneurysm was excluded. A coil was passed through the microcatheter; however, it was damaged and broke inside the catheter. The microcatheter was withdrawn, and an attempt was made to advance the coil using a saline flush,

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50105322 ↗

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