DELTAPAQ CERECYTE CDF100408-30Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00878528007258), received between Mar 30, 2018 and Mar 30, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Stretched” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 30, 2018Stretched; Stretched

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A COIL EMBOLIZATION OF AN INTRACRANIAL ANEURYSM, THE 4MM X 8CM DELTAPAQ THERMO-MECHANICAL DETACHABLE COIL DELIVERY SYSTEM (CDF10040830/C35249) COULD NOT BE ADVANCED THROUGH THE UNSPECIFIED MICROCATHETER. THE COIL WAS REPLACED WITHOUT INCIDENT. THE REPLACEMENT COIL AND THE SAME MICROCATHETER WERE USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS OCCURRED AS A RESULT OF THE EVENT. THE EVENT DID NOT RESULT IN A PROCEDURAL DELAY. AN ADEQUATE CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE MICROCATHETER. NO VISIBLE PRODUCT DAMAGE WAS NOTED PRIOR TO AND FOLLOWING THE EVENT. THERE WERE NO APPARENT KINKS IN THE MICROCATHETER THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. THE USER DID NOT APPLY EXCESSIVE FORCE AT ANY TIME DURING THE CASE. THE ASSOCIATED MICROCATHETER WILL NOT BE RETURNED FOR ANALYSIS. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7384741 ↗