DELTAPAQ CERECYTE CDF100208-30Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00878528007104), received between Aug 8, 2019 and Jun 10, 2022 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Separation Failure” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 10, 2022Separation Failure; Separation Failure

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, THE DOCTOR FILLED THE ANEURYSM WITH DELTAPAQ CERE 2MMX8CM COIL (CDF10020830, LOT UNKNOWN) AND PRESSED THE DETACHMENT BOX TO DETACH IT, BUT THE COIL COULD NOT BE DETACHED. THE PHYSICIAN RETRACTED THE COIL AND TO A NEW COMPETITOR¿S COIL TO COMPLETE THE SURGERY. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14652616 ↗
• MalfunctionNov 13, 2019Positioning Problem; Positioning Problem

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A COIL EMBOLIZATION, A 2MMX8CM DELTAPAQ CERE COIL (CDF10020830, C40907) WAS BEING AS USED AS A SECOND COIL. THE PHYSICIAN DIDN'T LIKE THE SHAPE OF COIL DEPLOYMENT AND DECIDED TO PULL IT OUT. DURING RE-SHEATHING THE COIL, THE INTRODUCER FAILED TO BE RE-ZIPPED. 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 9315186 ↗
• MalfunctionSep 26, 2019Separation Failure; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE STENT-ASSISTED COIL EMBOLIZATION OF AN ANEURYSM, THE 2MM X 8CM DELTAPAQ 10 CERECYTE COIL (CDF10020830 / S12660) COULD NOT BE DETACHED. THE RED ALARM LIGHT ILLUMINATED. PRIOR TO THE DETACHMENT ISSUE WITH THIS DELTAPAQ CERECYTE COIL, THERE WAS ONE COIL THAT WAS SUCCESSFULLY DETACHED AND IMPLANTED AT THE TARGET SITE. THE PHYSICIAN REPLACED THE CABLE AND THE ISSUE WAS STILL NOT RESOLVED; THE COIL STILL DID NOT DETACH. IT WAS REPORTED THAT THE SYSTEM FAULT OCCURRED AFTER ONE DETACHMENT CYCLE WAS ATTEMPTED; ONE COIL WAS SUCCESSFULLY DETACHED BEFORE THE ISSUE OCCURRED WITH THE COMPLAINT COIL. THE PHYSICIAN COMPLETED THE PROCEDURE WITH COMPETITOR PRODUCTS. THERE WAS NO REPORT OF ANY ADVERSE PATIENT EVENT OR COMPLICATION ASSOCIATED WITH THE REPORTED ISSUE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9126563 ↗
• MalfunctionAug 8, 2019Stretched; Stretched

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A COIL EMBOLIZATION, A 2.5MMX6CM DELTAPAQ CERE (CDF10025630, S12117) WAS NOT ABLE TO ADVANCE NOR RETRIEVED BY THE PHYSICIAN. THE PHYSICIAN PULLED THE COIL AND MICROCATHETER (MC) AT THE SAME TIME. AFTER INSPECTION IT TURNS OUT TO BE STRETCHED. 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 8875373 ↗