CERECYTE PRESIDIO PC4180933-30Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00878528003212), received between Jan 2, 2019 and Mar 9, 2021 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Difficult to Remove” (1 report).

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.

• MalfunctionMar 9, 2021Separation Failure; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE STENT-ASSISTED ANEURYSM EMBOLIZATION PROCEDURE, THE 9MM X 33CM PRESIDIO 18 CERECYTE COIL (PC418093330 / K10442) WAS DELIVERED TO THE TARGET POSITION BUT IT WAS REPORTED THAT THE COIL COULD NOT BE DETACHED. THE PHYSICIAN REMOVED THE COMPLAINT COIL FROM THE PATIENT AND SWITCHED TO ANOTHER COIL TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION. A PHOTO OF THE COMPLAINT DEVICE WAS INCLUDED IN THE COMPLAINT FILE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11448748 ↗
• InjuryJan 2, 2019Difficult to Remove; Stretched; Positioning Problem; Migration; Premature Separation; Difficult to Remove; Stretched; Positioning Problem; Migration; Premature Separation

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, A FAILURE OF THE INTERNAL COIL RESISTANT MATERIAL OCCURRED DURING USE OF A 9MM X 33CM PRESIDIO 18 CERE (PC418093330/C40834) THERMO-MECHANICAL COIL. IT WAS REPORTED THAT: "THERE ARE COMMENTS, WHICH STATE THAT IT WAS A PREMATURE DETACHMENT, BUT THE SURGEON FEELS THAT IT WASN¿T A PREMATURE DETACHMENT, BUT A FAILURE OF THE INTERNAL COIL RESISTANT MATERIAL, WHICH HAD SNAPPED, CAUSING A PART OF A COIL TO DISLODGE." NO PATIENT COMPLICATIONS OCCURRED AS A RESULT OF THE EVENT. THE COIL REMAINS IMPLANTED IN THE PATIENT AND IS THUS NOT AVAILABLE FOR EVALUATION. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Infarction, Cerebral; No Code Available; No Consequences Or Impact To Patient

  MAUDE report 8207769 ↗