DELTAPAQ CERECYTE CDF100203-30Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00878528007074), received between Aug 29, 2016 and Aug 18, 2020 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Positioning 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 18, 2020Positioning Problem; Positioning Problem

  AS REPORTED BY THE FILED, DURING A COIL EMBOLIZATION, THE PHYSICIAN DIDN'T LIKE THE SHAPE OF THE COIL DEPLOYMENT OF A 2MMX3CM (CDF10020330, L10246) AND DECIDED TO PULL IT OUT. DURING RESHEATHING OF THE COIL, THE INTRODUCER FAILED TO BE RE-ZIPPED. THE PHYSICIAN USED A SAME LIKE PRODUCT. THE PROCEDURE WAS SUCCESSFULLY FINISHED. THERE WAS NOT PATIENT INJURY REPORTED. THIS COIL WAS BEING USED AS A FILLING COIL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10420200 ↗
• MalfunctionMar 12, 2019Separation Failure; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE COIL EMBOLIZATION PROCEDURE OF THE ANTERIOR COMMUNICATING ARTERY ANEURYSM, THE 2MM X 3CM DELTAPAQ 10 CERECYTE COIL (CDF10020330/C40094) COULD NOT BE DETACHED WHEN IT WAS DELIVERED TO THE TARGET LESION. THE COIL WAS SUCCESSFULLY REMOVED FROM THE PATIENT; IT WAS STILL ATTACHED TO THE DELIVERY SYSTEM WHEN IT WAS REMOVED. THE COIL WAS ALSO NOT STRETCHED WHEN IT WAS REMOVED FROM THE PATIENT. THE COIL WAS REPLACED, AND IT WAS REPORTED THAT THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT ANY PATIENT INJURY OR ADVERSE EVENT, NO ADDITIONAL INTERVENTION PERFORMED. THERE WAS NO UNDUE FORCE APPLIED AT ANY TIME. THERE WAS NO PROCEDURAL DELAY AS A RESULT OF THE REPORTED EVENT. IT WAS REPORTED THAT A PRE-DEPLOYMENT CHECK WAS PERFORMED AND THE SAME DETACHMENT BOX AND CONNECTING CABLE WAS USED TO DETACH THE SUBSEQUENT COILS. THE LOW BATTERY AND FAULT LIGHTS WERE NOT SEEN DURING THE CASE. THE SYSTEM READY LIGHT DID ILLUMINATE ON THE ENPOWER CONTROL CABLE AND THERE WAS THE AUDIBLE SIGNAL BEEP DURING THE DETACHMENT CYCLE. IT WAS CONFIRMED THAT ALL CONNECTIONS APPEARED TO FIT PROPERLY WITHOUT APPLICATION OF EXCESSIVE FORCE. THE COMPLAINT PRODUCT WAS

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8414669 ↗
• MalfunctionAug 1, 2018Separation Failure; Material Deformation; Separation Failure; Material Deformation

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, THE 2 MM X 3 CM DELTAPAQ CERE (CDF10020330/C24107) THERMO-MECHANICAL COIL FAILED TO DETACH. THERE WAS NO REPORT OF CONSEQUENCE OR IMPACT TO THE PATIENT. IT WAS REPORTED THAT THE INFORMATION PROVIDED FOR THIS COMPLAINT WAS ALL OF THE DETAILS THAT WERE KNOWN/AVAILABLE REGARDING THIS EVENT. THE PRODUCT WILL BE RETURNED FOR ANALYSIS. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7739935 ↗
• MalfunctionDec 14, 2016Positioning Failure; Positioning Failure

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING COIL EMBOLIZATION PROCEDURE THE DELTAPAQ 2MM X 3 CM (CDF10020330/C30399) COIL FAILED TO DETACH. THE COIL WAS WITHDRAWN AND A NEW COIL WAS USED TO COMPLETE THE PROCEDURE. THE COIL WAS STILL ATTACHED TO THE DELIVERY SYSTEM WHEN REMOVED FROM THE PATIENT. THERE WERE NO DAMAGES NOTED TO THE COIL/COIL DELIVERY SYSTEM/DETACHMENT SYSTEM PRIOR TO USE OR AFTER REMOVAL. A PRE-DEPLOYMENT ELECTRICAL CHECK WAS PERFORMED AND THE GREEN SYSTEM READY LIGHT ILLUMINATED; DURING THE DETACHMENT CYCLE THE DETACHMENT LIGHT DID NOT ILLUMINATE. ALL CONNECTIONS APPEARED TO FIT PROPERLY WITHOUT APPLICATION OF EXCESSIVE FORCE. THE SAME CONNECTING CABLE AND DCB WERE USED SUCCESSFULLY WITH SUBSEQUENT COILS. THERE WAS NO REPORT ON THE PATIENT INJURY. THERE WERE NO INTRA OR POST PROCEDURAL COMPLICATIONS OR DELAYS RELATED TO THE DEVICE OR REPORTED EVENT. THE PATIENT INFORMATION IS UNKNOWN. IT WAS INITIALLY REPORTED THAT THE COMPLAINT PRODUCT IS AVAILABLE FOR RETURN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6173327 ↗
• MalfunctionAug 29, 2016Positioning Failure; Positioning Failure

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, 5 DELTAPAQ COILS (CDF10015230/ C37792, CDF10025430/ C36045, CDF10020430/ C36101, CDF10020330/ C40094 AND CDF10030630/ C37174) FAILED TO DETACH. THE DETACHMENT CABLE AND DCB WERE CHANGED, BUT THE COILS COULD NOT BE DETACHED. ALL OF THE COILS WERE USED IN THE SAME CASE, BUT NOT USED CONSECUTIVELY. THERE WERE NO POTENTIAL PATIENT ADVERSE EVENTS. IT WAS REPORTED THAT PRODUCT WOULD BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5910162 ↗