DELTAPLUSH CERECYTE CPL100206-30Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00878528008231), received between Nov 9, 2016 and Aug 4, 2022 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (2 reports).

1 other recall cover devices cleared under the same FDA submission (K083646); they may or may not involve this specific model.

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 16, 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 15170605 ↗
• MalfunctionMay 4, 2022Stretched; Failure to Advance; Stretched; 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14274668 ↗
• MalfunctionJan 14, 2019Material Twisted/Bent; Material Twisted/Bent

  A REPORT WAS RECEIVED THAT DURING A COIL EMBOLIZATION, THE 2MM X 4CM DELTAPLUSH 10 (CPL10020430/C24954) AND 2MM X 6CM DELTAPLUSH 10 (CPL10020630/L10055) COILS WERE NOTED TO BE KINKED AND COULD NOT BE DEPLOYED/INSERTED INTO THE EMBOLIZATION. THE COILS WERE REPLACED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. IT WAS NOT REPORTED IF THE COILS WERE REMOVED WITHOUT THE NEED FOR ADDITIONAL INTERVENTION. THE SURGERY WAS NOT DELAYED DUE TO THE EVENT. THERE WAS NO REPORT OF CONSEQUENCE OF IMPACT TO THE PATIENT. THE PRODUCTS WILL BE RETURNED FOR EVALUATION. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8245813 ↗
• MalfunctionJul 23, 2018Separation Failure; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE PROCEDURE, THE DELTAPLUSH 10 CERECYTE COIL 2MM X 6CM ((B)(4)) COULD NOT BE DETACHED. THE COIL WAS WITHDRAWN AND ANOTHER COIL WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF ANY PATIENT INJURY OR CONSEQUENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7712615 ↗
• MalfunctionOct 17, 2017Positioning Failure; Positioning Failure

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL THAT A DELTAPLUSH COIL (CPL10020630/C26421) COULD NOT BE DETACHED DURING A PROCEDURE. ANOTHER ONE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6954355 ↗
• MalfunctionMar 13, 2017Physical Resistance; Deformation Due to Compressive Stress; Physical Resistance; Deformation Due to Compressive Stress

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING COIL EMBOLIZATION OF A 4.7MM X 5.5MM LEFT INTERNAL CAROTID ARTERY ANEURYSM, THE DELTAPLUSH COIL (CPL10020630/ C35990) COULD NOT EXIT THE INTRODUCER, AND DURING PRODUCT ANALYSIS, IT WAS CONFIRMED THAT THE PROXIMAL END OF THE COIL HAD SEVERE COMPRESSION AND BUCKLING DAMAGE. THEY USED A NEW COIL TO COMPLETE THE PROCEDURE. THE DEVICE HAD BEEN PREPPED AS PER THE IFU. THERE WAS NO REPORT OF PATIENT INJURY OR PROCEDURE DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6399026 ↗
• MalfunctionNov 9, 2016Stretched; Stretched

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A PROCEDURE PRIOR TO BEING USED ON THE PATIENT A KINK WAS FOUND ON THE INTRODUCER OF A DELTAPLUSH CERECYTE COIL 2MM X 6 CM (CPL10020630/C35465). PATIENT INFORMATION AND PROCEDURE DETAILS ARE UNKNOWN. THERE WAS ONLY A MINOR DELAY IN THE PROCEDURE AND THERE WERE NO INTRA OR POST PROCEDURAL COMPLICATIONS RELATED TO DEVICE OR THE REPORTED EVENT. IT WAS INITIALLY REPORTED THAT THE DEVICE IS AVAILABLE FOR RETURN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6089085 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K083646. One submission often covers many models, so check the product and lot details in each record.

• Z-0845-2011 · Oct 21, 2010 · Terminated
  Micrus Endovascular Microcoil Delivery System; The Micrus Microcoil Delivery System consists of three components, a Microcoil System, a Connecting Cable, and a Detachment Control B