DELTAPAQ CERECYTE CDF100304-30Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00878528007180), received between Jan 9, 2017 and Aug 8, 2019 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Positioning Failure” (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, 2019Stretched; Stretched

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A COIL EMBOLIZATION, A 3MMX4CM DELTAPAQ CERE (CDF10030430, L13129) 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 8875316 ↗
• MalfunctionJan 9, 2017Positioning Failure; Positioning Failure

  AS REPORTED BY HEALTH CARE PROFESSIONAL, DURING A COIL EMBOLIZATION PROCEDURE A DELTPAQ CERE 3M X 4 CM ((B)(4)) COIL FAILED TO DETACH. THE COIL WAS WITHDRAWN FROM THE PATIENT AND WAS STILL ATTACHED TO THE DELIVERY SYSTEM; A NEW COIL WAS USED TO COMPLETE THE PROCEDURE. THE PRE-DEPLOYMENT ELECTRICAL CHECK WAS PERFORMED AND THE GREEN SYSTEM READY LIGHT ILLUMINATED. THE DETACHMENT LIGHT DID NOT ILLUMINATE AND THE AUDIBLE SIGNAL DID NOT BEEP. ALL CONNECTIONS APPEARED TO FIT PROPERLY WITHOUT APPLICATION OF EXCESSIVE FORCE. THE SAME CONNECTING CABLE AND DCB WERE USED SUCCESSFULLY WITH SUBSEQUENT COILS. THERE WERE NO INTRA OR POST PROCEDURAL COMPLICATIONS OR DELAYS RELATED TO DEVICE OR REPORTED EVENT. THE PATIENT WAS A (B)(6) YEAR OLD FEMALE. THERE WAS NO REPORT ON THE PATIENT INJURY AND PATIENT OUTCOME WAS REPORTED TO BE FINE. IT WAS INITIALLY REPORTED THAT THE COMPLAINT PRODUCT IS AVAILABLE FOR RETURN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6233660 ↗