DELTAPAQ CERECYTE CDF100156-30Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00878528007043), received between Dec 19, 2017 and Aug 4, 2022 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Separation Failure” (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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 4, 2022Failure to Advance; Failure to Advance

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, THE PHYSICIAN FILLED THE TARGET ANEURYSM WITH THE FIRST COIL, A 2MM X 6CM DELTAPLUSH 10 CERECYTE COIL (CPL10020630 / S14489) AND OBSERVED THAT IT WAS IMPEDED IN THE INTRODUCER. THE PHYSICIAN ADJUSTED THE COIL AND PUSHED IT OUT FROM THE INTRODUCER, HOWEVER, THE COIL WAS FOUND TO HAVE UNRAVELED / STRETCHED. THE PHYSICIAN USED THE SECOND COIL, ANOTHER 2MM X 6CM DELTAPLUSH 10 CERECYTE COIL (CPL10020630 / S14489), BUT IT WAS ALSO IMPEDED IN THE INTRODUCER AND COULD NOT BE PUSHED. A THIRD COIL, A 1.5MM X 6CM DELTAPAQ 10 CERECYTE COIL (CDF10015630 / 30429053) WAS USED BUT THIS COIL ALSO WAS IMPEDED IN THE INTRODUCER AND COULD NOT BE PUSHED OUT. NEW DEVICES WERE USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION. THE COMPLAINT DEVICE WAS RETURNED FOR EVALUATION AND ANALYSIS. BASED ON THE RESULT OF THE PRODUCT ANALYSIS COMPLETED ON 04-AUG-2022, THE EVENT HAS BEEN DEEMED REPORTABLE AS A "MALFUNCTION."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15170601 ↗
• MalfunctionDec 31, 2020Separation Failure; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE ANEURYSM COIL EMBOLIZATION PROCEDURE, IT WAS REPORTED THAT THE 1.5MM X 6CM DELTAPAQ 10 CERECYTE COIL (CDF10015630 / S11973) COULD NOT BE DETACHED WHEN IT REACHED THE TARGET POSITION. THE PHYSICIAN SWITCHED TO A NEW COIL SYSTEM TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11103211 ↗
• MalfunctionSep 22, 2020Separation Failure; Separation Failure

  AS REPORTED BY THE FIELD, DURING AN AUXILIARY ANEURYSM EMBOLIZATION, A 1.5MMX6CM DELTAPAQ CERE COIL (CDF10015630, S13582) 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 THE CONTROL CABLE WERE USED SUCCESSFULLY WITH SUBSEQUENT COILS. THE COIL WAS STILL ATTACHED TO THE COIL DELIVERY SYSTEM WHEN IT WAS REMOVED FROM THE PATIENT. THE COIL WAS NOT STRETCHED, OR DAMAGED WHEN IT WAS 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 EVENT PROLONGED THE PROCEDURE BY A FEW MINUTES. THE PHYSICIAN DID NOT FEEL THE PROLONGATION OF PROCEDURE WAS CLINICALLY SIGNIFICANT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10568052 ↗
• MalfunctionAug 5, 2020Material Twisted/Bent; Material Twisted/Bent

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, A 1.5MMX4CM DELTAPAQ CERE COIL (CDF10015430, S13544) IMPEDED IN THE MICROCATHETER (MC). IT WAS REPORTED THAT PHYSICIAN FOUND FORCE WHEN HE PUSHED FIRST COIL WITHIN MICROCATHETER, THEN HE WITHDREW THE FIRST COIL OUTSIDE OF THE PATIENT. THE PHYSICIAN CHANGED TO A NEW 1.5MMX6CM DELTAPAQ CERE (CDF10015630, S14515), BUT STILL FAILED TO ADVANCE. PHYSICIAN WITHDREW THE SECOND COIL OUTSIDE OF PATIENT. HE CHANGED TO USE A GALAXY COIL AND WAS ABLE TO PUSH SMOOTHLY WITHIN THE SAME MC. THE PHYSICIAN IMPLANTED A SECOND GALAXY COIL SUCCESSFULLY AS WELL. THEREFORE, THE PROCEDURE WAS COMPLETED BY THE TWO GALAXY COILS. THERE WAS NO PATIENT INJURY REPORTED. THE TARGET CEREBRAL POSITION WAS NOT LOST. NO ADDITIONAL INFORMATION IS AVAILABLE. BASED ON THE PRODUCT ANALYSIS OF THE 1.5MMX6CM DELTAPAQ CERE, THE EMBOLIC COIL WAS NOTED TO BEING KINKED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10369067 ↗
• MalfunctionMay 27, 2020Separation Failure; Separation Failure

  AS REPORTED BY THE FIELD, DURING AN ANEURYSM EMBOLIZATION, A 1.5MMX6CM DELTAPAQ CERE COIL (CDF10015630, (B)(4)) COULDN'T BE DETACHED. THE PHYSICIAN REPLACED THE DEVICE FOR A 1.5MMX6CM DELTAPAQ CERE (CDF10015630, (B)(4)) BUT IT FAILED TO DETACH TOO. THEN THE PHYSICIAN CHANGED THE DEVICE AND THE THIRD WAS ABLE TO FINALLY DETACH SUCCESSFULLY. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10092401 ↗
• MalfunctionMay 27, 2020Separation Failure; Separation Failure

  AS REPORTED BY THE FIELD, DURING AN ANEURYSM EMBOLIZATION, A 1.5MMX6CM DELTAPAQ CERE COIL (CDF10015630, S13690) COULDN'T BE DETACHED. THE PHYSICIAN REPLACED THE DEVICE FOR A 1.5MMX6CM DELTAPAQ CERE (CDF10015630, S14698) BUT IT FAILED TO DETACH TOO. THEN THE PHYSICIAN CHANGED THE DEVICE AND THE THIRD WAS ABLE TO FINALLY DETACH SUCCESSFULLY. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10092399 ↗
• MalfunctionDec 19, 2017Positioning Failure; Positioning Failure

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL THAT A DELTAPAQ COIL ((B)(4)/UNKNOWN LOT) WAS USED DURING A PROCEDURE AND THE COIL COULD NOT BE DETACHED. THIS WAS THE THIRD COIL USED DURING THE PROCEDURE. THE COIL WAS WITHDRAWN AND ANOTHER COIL WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7131492 ↗