DELTAPAQ CERECYTE CDF100206-30Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00878528007098), received between Apr 23, 2018 and Aug 8, 2019 — classified as 2 malfunctions.

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

• MalfunctionAug 8, 2019Separation Failure; Separation Failure

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A COIL EMBOLIZATION, WHEN THE PHYSICIAN TRIED TO DETACH A 2MMX6CM DELTAPAQ CERE (CDF10020630, S12587), THE BEEPING SOUND WAS NORMAL. HOWEVER, DURING RETRIEVING DELIVERY SYSTEM, IT CONTINUOUSLY CAME OUT ALONG THE DELIVERY SYSTEM. THE PHYSICIAN USED A SAME LIKE PRODUCT. THE PROCEDURE WAS SUCCESSFULLY FINISHED. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8875381 ↗
• MalfunctionApr 23, 2018Kinked; Kinked

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, THE PHYSICIAN ENCOUNTERED STRONG RESISTANCE ADVANCING THE 2MM X 6CM DELTAPAQ THERMO-MECHANICAL DETACHABLE COIL DELIVERY SYSTEM (CDF10020630/ S11810) THROUGH THE PROWLER LPES MICROCATHETER. THE COIL DELIVERY SYSTEM GOT STUCK AND COULD NO LONGER ADVANCE. THE COIL WAS REPLACED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE PROWLER LPES MICROCATHETER WAS NOT REMOVED WITH THE COIL. THE SAME MICROCATHETER WAS USED TO COMPLETE THE CASE; THUS, THERE WAS NO LOSS OF CEREBRAL TARGET POSITION ASSOCIATED WITH THE ISSUE. NO PATIENT COMPLICATIONS OCCURRED AS A RESULT OF THE EVENT. THE PRODUCT WAS STORED AND PREPPED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). APPROXIMATELY 3-4 COILS WERE ADVANCED THROUGH THE SAME MICROCATHETER PRIOR TO THIS COIL. AN ADEQUATE CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE CATHETER. THE ASSOCIATED MICROCATHETER WAS DISCARDED AND THUS IS NOT AVAILABLE FOR RETURN. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7451740 ↗