DELTAPAQ CERECYTE CDF100308-30Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00878528007203), received between Oct 20, 2016 and Aug 26, 2020 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Positioning Problem” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 26, 2020Positioning Problem; Positioning Problem

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, A 3MMX8CM DELTAPAQ CERE COIL (CDF10030830, S11444) WAS BEING USED AS THE SECOND COIL. THE PHYSICIAN DIDN'T LIKE THE SHAPE OF THE COIL DEPLOYMENT AND DECIDED TO PULL IT OUT. DURING RESHEATHING 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 10453619 ↗
• MalfunctionMar 17, 2020Positioning Problem; Positioning Problem

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE PROCEDURE, THE 3MM X 8CM DELTAPAQ 10 CERECYTE COIL (CDF10030830 / S11444) WAS USED AS A FILLING COIL, BUT THE PHYSICIAN DID NOT LIKE THE SHAPE OF THE COIL DEPLOYMENT AND DECIDED TO REMOVE THE COIL. DURING THE RESHEATHING ATTEMPT, THE COIL INTRODUCER FAILED TO BE RE-ZIPPED. THE PHYSICIAN USED ANOTHER 3MM X 8CM DELTAPAQ 10 CERECYTE COIL AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9844915 ↗
• MalfunctionOct 3, 2019Stretched; Physical Resistance/Sticking; Stretched; Physical Resistance/Sticking

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A COIL EMBOLIZATION, A 3MMX8CM DELTAPAQ CERE COIL (CDF10030830, S13698) WAS BEING USED AS THE SECOND COIL, HOWEVER, THE COIL COULDN'T BE ADVANCED NOR RETRIEVED BY THE PHYSICIAN. THE PHYSICIAN PULLED THE COIL AND THE UNKNOWN MICROCATHETER 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 REPORT OF PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9152092 ↗
• MalfunctionOct 3, 2019Separation Failure; Separation Failure

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A COIL EMBOLIZATION, WHEN THE PHYSICIAN TRIED TO DETACH A 3MMX8CM DELTAPAQ CERE COIL (CDF10030830, S11444) THE BEEPING SOUND WAS NORMAL BUT DURING THE 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 9152076 ↗
• MalfunctionApr 27, 2018Kinked; Stretched; Kinked; Stretched

  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 7468189 ↗
• MalfunctionOct 20, 2016Positioning Failure; Positioning Failure

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING COIL EMBOLIZATION, THE DELTAPAQ COIL (CDF10030830/ C27888) COULD NOT BE DETACHED. THEY SUCCESSFULLY WITHDREW THE COIL AND USED A NEW COIL TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF PATIENT INJURY OR CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THE COIL WAS NOT STRETCHED WHEN IT WAS REMOVED AND WAS STILL ATTACHED TO THE DELIVERY SYSTEM. AN UNSPECIFIED ENPOWER CABLE AND DCB WERE USED FOR THE PROCEDURE, AND THE SAME CABLE AND DCB WERE USED TO SUCCESSFULLY DETACH THE SUBSEQUENT COILS. A PRE-DEPLOYMENT ELECTRICAL CHECK HAD BEEN PERFORMED. THE GREEN SYSTEM READY LIGHT ILLUMINATED. ALL CONNECTIONS APPEARED TO FIT PROPERLY WITHOUT APPLICATION OF EXCESSIVE FORCE. IT WAS UNKNOWN IF DURING THE DETACHMENT CYCLE THE DETACHMENT LIGHT ILLUMINATED OR THE AUDIBLE SIGNAL BEEPED. INFORMATION REGARDING THE TARGET VESSEL AND PATIENT INFORMATION COULD NOT BE OBTAINED. IT WAS REPORTED THAT THE DEVICE WOULD BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6043363 ↗