DELTAPAQ CERECYTE CDF100204-30Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00878528007081), received between Aug 29, 2016 and Jan 30, 2024 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Stretched” (5 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 30, 2024Stretched; Stretched

  AS REPORTED BY THE FIELD, DURING THE PROCEDURE, THE PHYSICIAN FILLED THE ANEURYSM WITH A DELTAPAQ CERE 2MMX4CM COIL (CDF10020430, 30436877). IT WAS FOUND THAT THE COIL WAS UNRAVELED/STRETCHED. THE PHYSICIAN RETRACTED THE COIL AND SWITCHED TO A NEW ONE TO COMPLETE THE SURGERY. THE MICROCATHETER WAS NOT REPLACED. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18609652 ↗
• MalfunctionMay 18, 2020Stretched; Stretched

  AS REPORTED BY THE FIELD, DURING A PERCUTANEOUS INTRACRANIAL ANEURYSM EMBOLIZATION AND DURING THE USE OF A 2MMX4CM DELTAPAQ CERE COIL (CDF10020430, S13691), THE INTRODUCER WAS DAMAGED, AND THE COIL EXPOSED. IT WAS REPORTED THAT THE COIL COULDN'T ADVANCE WITHIN THE INTRODUCER. THE PHYSICIAN PUSHED THE DELIVERY WIRE, THEN INTRODUCER BROKE AND THE COIL RUN OUTSIDE OF THE INTRODUCER. THEREFORE, THE COIL DIDN'T ARRIVE AT THE Y-CONNECTOR. THE DEVICE WAS NOT USED IN THE PATIENT. THERE WAS NO PATIENT INJURY REPORTED. ADDITIONAL INFORMATION RECEIVED CLARIFIED THAT THE INTRODUCER RUPTURED. NO ADDITIONAL INFORMATION IS AVAILABLE. BASED ON THE DEVICE ANALYSIS, THE EMBOLIC COIL WAS NOTED STRETCHED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10065109 ↗
• MalfunctionOct 3, 2019Separation Failure; Separation Failure

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A COIL EMBOLIZATION, A 2MMX4CM DELTAPAQ CERE COIL (CDF10020430, S14868) WAS BEING USED AS A SECOND COIL. HOWEVER, WHEN THE PHYSICIAN TRIED TO DETACH THE COIL, THE BEEPING SOUND WAS NORMAL BUT DURING 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 REPORT OF PATIENT INJURY. AN ENPOWER DETACHABLE CONTROL BOX (DCB) WAS USED IN THIS CASE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9151995 ↗
• MalfunctionAug 13, 2019Stretched; Stretched

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE PROCEDURE, THE PHYSICIAN COULD NOT ADVANCE NOR RETRIEVE THE 2MM X 4 CM DELTAPAQ 10 CERECYTE COIL (CDF10020430 / S14774). AS A RESULT, THE PHYSICIAN HAD TO REMOVE BOTH THE COIL AND THE MICROCATHETER. THE COIL WAS INSPECTED AFTER REMOVAL AND WAS NOTED TO BE STRETCHED. THE PHYSICIAN USED ANOTHER 2MM X 4 CM DELTAPAQ 10 CERECYTE COIL TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF ANY PATIENT COMPLICATION OR ADVERSE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8889443 ↗
• MalfunctionJun 11, 2019Stretched; Stretched

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE COIL EMBOLIZATION PROCEDURE TO TREAT AN INTRACRANIAL ANEURYSM, THE 2MM X 4 CM DELTAPAQ 10 CERECYTE COIL (CDF10020430 / (B)(4)) BECAME STRETCHED WHEN IT REACHED THE TARGET LESION. THE COIL WAS REPLACED WITH ANOTHER 2MM X 4 CM DELTAPAQ 10 CERECYTE COIL AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORT OF PATIENT INJURY OR COMPLICATION. IT WAS REPORTED THAT THE PRODUCT IS AVAILABLE TO BE RETURNED FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8689526 ↗
• MalfunctionDec 28, 2017Stretched; Stretched

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL THAT A DELTAPAQ COIL (B)(4) WAS USED DURING A PROCEDURE AND THE COIL STRETCHED. ANOTHER COIL WAS USED TO COMPLETE THE PROCEDURE AND THERE WAS NO REPORT OF PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7153560 ↗
• MalfunctionMay 11, 2017Kinked; Deformation Due to Compressive Stress; Kinked; Deformation Due to Compressive Stress

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, A PHYSICIAN FELT STRONG RESISTANCE DURING ADVANCED A DELTAPLUSH (CPL10015330/ C40127), A DELTAPAQ (CDF10020430/ C33041) AND A PRESIDIO (PC410073030/ C41431) THROUGH A HEADWAY 17 MICROCATHETER. UPON RETURN OF THE DEVICES FOR ANALYSIS, THE DELTAPLUSH AND DELTAPAQ COILS WERE FOUND TO BE COMPRESSED AND BUCKLED AND THE PRESIDIO COIL WAS STRETCHED. OTHER COILS WERE ABLE TO BE ADVANCED. THE PHYSICIAN REPLACED THE COILS WITH SAME LIKE PRODUCTS AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO POTENTIAL ADVERSE EVENTS. AFTER MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION, NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6559782 ↗
• 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 5910150 ↗