DELTAPAQ CERECYTE CDF100515-30Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00878528007302), received between Jun 19, 2017 and May 7, 2019 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Stretched” (2 reports).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 7, 2019Stretched; Difficult or Delayed Activation; Stretched; Difficult or Delayed Activation

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE COIL EMBOLIZATION PROCEDURE, AFTER THE FIRST COIL CHOSEN TO START THE PROCEDURE, THE 3 MM X 10 CM DELTAPAQ 10 CERECYTE COIL (CDF10031030 / C35111) ENCOUNTERED DIFFICULTY WITH BEING COMPLETELY DEPLOYED FROM THE MICROCATHETER, IT WAS REPLACED WITH THE 5MM X 15CM DELTAPAQ 10 CERECYTE COIL (CDF10051530 / S14517), AND THE SAME ISSUE OCCURRED; THE COIL COULD NOT BE COMPLETELY DEPLOYED FROM THE MICROCATHETER. THERE WAS NO REPORT OF ANY PATIENT INJURY OR COMPLICATION. THE PRODUCTS ARE AVAILABLE TO BE RETURNED FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8588427 ↗
• MalfunctionApr 27, 2018Premature Activation; Premature Activation

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, A TOTAL OF THREE THERMO-MECHANICAL COILS, ONE 3MM X 6CM DELTAPAQ (CDF10030630/UNK LOT), ONE 3MM X 8CM DELTAPAQ (CDF10030830/UNK LOT), AND ONE 5MM X 15CM DELTAPAQ (CDF10051530/UNK LOT), FAILED TO RE-SHEATH DURING THE PROCEDURE. THE COILS WERE REPLACED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO REPORT OF CONSEQUENCE OR IMPACT TO THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7468205 ↗
• MalfunctionJun 19, 2017Difficult To Position; Stretched; Difficult To Position; Stretched

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING THE PROCEDURE, THE DELTAPAQ COIL (CDF10051530/ C39413) COULD NOT BE INSERTED INTO THE ANEURYSM DUE TO POSITIONING DIFFICULTY AND STRETCHED. THEY WITHDREW THE COIL WITHOUT DIFFICULTY, AND USED A NEW COIL TO COMPLETE THE PROCEDURE. THERE HAD BEEN NO RESISTANCE BETWEEN THE DELTAPAQ AND THE MICROCATHETER, AND A CONTINUOUS FLUSH HAD BEEN MAINTAINED THROUGH THE MICROCATHETER. ANEURYSM CHARACTERISTICS AND SIZE WERE UNAVAILABLE. THERE WAS NO REPORT OF PATIENT INJURY OR PROCEDURE DELAY. IT WAS REPORTED THAT THE DEVICE WOULD BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6650488 ↗