DELTAPAQ CERECYTE CDF100310-30Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00878528007210), received between Oct 31, 2017 and Sep 22, 2020 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Stretched” (4 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.

• MalfunctionSep 22, 2020Separation Failure; Separation Failure

  AS REPORTED BY THE FIELD, DURING AN AUXILIARY ANEURYSM COIL EMBOLIZATION, A DELTAPAQ CERECYTE COIL (CDF10031030, S12829) COULDN¿T BE RELEASED WHEN IT ARRIVED THE CEREBRAL TARGET POSITION. THE PHYSICIAN WITHDREW IT, AND USED ANOTHER NEW COIL TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT HARM REPORTED. ADDITIONAL INFORMATION RECEIVED INDICATED THAT PRE-DEPLOYMENT ELECTRICAL TESTING WAS PERFORMED. THE SAME DETACHABLE CONTROL BOX (DCB), AND CABLE WERE SUCCESSFULLY USED WITH SUBSEQUENT COILS. THE COIL WAS STILL ATTACHED TO THE COIL DELIVERY SYSTEM WHEN IT WAS REMOVED FROM THE PATIENT. THE COIL DID NOT STRETCH, OR BECOME DAMAGED WHEN REMOVED FROM THE PATIENT. NO EXCESSIVE FORCE WAS APPLIED TO THE DEVICE. IT WAS NOT NECESSARY TO REMOVE CONCOMITANT DEVICES WITH THE COMPLAINT DEVICE. ADEQUATE FLUSH WAS MAINTAINED THROUGH THE DEVICES. THE PROCEDURAL WAS DELAYED BY A FEW MINUTES, LESS THAN 30MINUTES, DUE TO THE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10567856 ↗
• MalfunctionMay 7, 2019Stretched; Difficult or Delayed Activation; Stretched; Difficult or Delayed Activation

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE COIL EMBOLIZATION PROCEDURE, THE 3 MM X 10 CM DELTAPAQ 10 CERECYTE COIL (CDF10031030 / C35111) WAS THE COIL CHOSEN TO START THE PROCEDURE, BUT THE COIL COULD NOT BE COMPLETELY DEPLOYED OUT OF THE MICROCATHETER. THE COIL WAS REPLACED WITH THE 5MM X 15CM DELTAPAQ 10 CERECYTE COIL (CDF10051530 / S14517), AND THE SAME ISSUE OCCURRED. THERE WAS NO REPORT OF ANY PATIENT INJURY OR COMPLICATION. THE PRODUCTS ARE AVAILABLE TO BE RETURNED FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8588428 ↗
• MalfunctionApr 1, 2019Stretched; Stretched

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE COIL EMBOLIZATION PROCEDURE OF AN ANEURYSM, THE 3 MM X 10 CM DELTAPAQ 10 CERECYTE COIL (CDF10031030 / LOT#: UNKNOWN) THE PHYSICIAN WAS REPOSITIONING THE COIL IN ANEURYSM AND WAS ATTEMPTING TO RESHEATH THE COIL WHEN IT BECAME STRETCHED. THE RESHEATHING ATTEMPT WAS MADE WHEN THE COIL WAS PARTIALLY DEPLOYED; IT WAS CONFIRMED THAT THE COIL WAS NOT USED AS A GUIDEWIRE. IT WAS CONFIRMED THAT CONTINUOUS FLUSH HAD BEEN MAINTAINED IN THE SL-10® MICROCATHETER (STRYKER). THERE WAS NO RESISTANCE BETWEEN THE GUIDEWIRE AND THE MICROCATHETER, NO RESISTANCE AT ANY TIME DURING THE ADVANCEMENT OF THE COIL THROUGH THE MICROCATHETER. PRIOR TO THE REPORTED ISSUE WITH THE DELTAPAQ 10 CERECYTE COIL, OTHER COILS (QUANTITY NOT KNOWN) WERE ADVANCED THROUGH THE SAME MICROCATHETER. THE ENTIRE COIL WAS SAFELY REMOVED UNDETACHED. THERE WAS NO FLOW RESTRICTION OR REDUCTION ASSOCIATED WITH THE EVENT; NO CLINICALLY SIGNIFICANT PROCEDURAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT COMPLICATIONS. THERE WAS NO REPORT OF PATIENT INJURY OR ADVERSE EVENT. IT WAS REPORTED THAT THE PRODUCT IS AVAILABLE TO BE RETURNED FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8470948 ↗
• MalfunctionMar 20, 2018Kinked; Kinked

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, ABNORMAL FRICTION WAS ENCOUNTERED BETWEEN THE COIL DELIVERY WIRE AND THE COIL INTRODUCER OF A 3 MM X 10 CM DELTAPAQ 10 CERECYTE THERMO-MECHANICAL DETACHABLE COIL SYSTEM (DCS) (CDF10031030/LOT UNKNOWN). IT IS NOT KNOWN HOW THE PROCEDURE WAS COMPLETED OR IF THERE WAS ANY INJURY TO THE PATIENT. IT WAS NOT REPORTED IF THE PRODUCT WILL BE RETURNED FOR ANALYSIS. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7356480 ↗
• MalfunctionMar 20, 2018Premature Activation; Stretched; Premature Activation; Stretched

  A REPORT WAS RECEIVED THAT DURING A COIL EMBOLIZATION OF A LEFT MAXILLARY ARTERY ANEURYSM, THE 3 MM X 10 CM DELTAPAQ (CDF10031030/P11731) THERMO-MECHANICAL COIL DELIVERY SYSTEM WAS INTRODUCED INTO THE PATIENT AND WHILE BEING POSITIONED AT THE TARGET VESSEL, THE COIL WAS NOTED TO BE STRETCHED. THERE WAS NO REPORT OF PATIENT INJURY. IT WAS NOT REPORTED IF THE PRODUCT WILL BE RETURNED FOR EVALUATION. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7352858 ↗
• MalfunctionOct 31, 2017Material Separation; Stretched; Material Separation; Stretched

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING TREATMENT OF A 3.1 X 2.2MM POSTERIOR COMMUNICATING ARTERY ANEURYSM, A DELTAPAQ COIL (CDF10031030/C35555) COULD NOT BE ADVANCED VIA THE UNSPECIFIED PROWLER 14 MICROCATHETER, AND PRODUCT ANALYSIS REVEALED THAT THE COIL WAS STRETCHED WITH THE BALL TIP ABSENT. A CONTINUOUS FLUSH HAD BEEN MAINTAINED THROUGH THE MICROCATHETER AND THE DEVICES HAD BEEN PREPPED AND USED AS PER THE INSTRUCTIONS FOR USE. NEITHER DEVICE APPEARED DAMAGED. THEY USED ANOTHER COIL TO COMPLETE THE PROCEDURE WITHOUT LOSS OF TARGET POSITION. THERE WAS NO REPORT OF PATIENT INJURY OR PROCEDURE DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6990197 ↗