DELTAPAQ CERECYTE CDF100210-30Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00878528007111), received between Oct 4, 2016 and Sep 1, 2020 — classified as 3 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Physical Resistance” (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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 1, 2020Positioning Problem; Positioning Problem

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, A 2MMX10CM DELTAPAQ CERE COIL (CDF10021030, S13731) WAS BEING USED AS THE THIRD COIL. THE PHYSICIAN DIDN'T LIKE THE SHAPE OF THE COIL DEPLOYMENT AND DECIDED TO PULL IT OUT. DURING RESHEATHING, THE COIL INTRODUCER FAILED TO BE RE-ZIPPED. THE PHYSICIAN USED A SAME LIKE PRODUCT. THE PROCEDURE WAS SUCCESSFULLY FINISHED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10477745 ↗
• MalfunctionAug 31, 2020Material Twisted/Bent; Premature Separation; Material Twisted/Bent; Premature Separation

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE STENT-ASSISTED ANEURYSM EMBOLIZATION PROCEDURE TARGETING A LEFT POSTERIOR COMMUNICATING ARTERY (PCOMM) ANEURYSM, THE 2MM X 10CM DELTAPAQ 10 CERECYTE COIL (CDF10021030 / L10870) UNEXPECTEDLY BECOME DETACHED WHEN THE COIL WAS IN THE INTRODUCER BEFORE CROSSING THE MICROCATHETER. ANOTHER 2MM X 10CM DELTAPAQ 10 CERECYTE COIL WAS USED TO COMPLETE THE PROCEDURE. THE REPORTED ISSUE DID NOT CAUSE A PROCEDURAL DELAY. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10473456 ↗
• MalfunctionJul 30, 2018Separation Failure; Separation Failure

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A COIL EMBOLIZATION PROCEDURE, THE 2 MM X 10 CM DELTAPAQ (CDF10021030/UNK LOT) 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 AVAILABILITY OF THE PRODUCT IS CURRENTLY UNKNOWN. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7732632 ↗
• MalfunctionMar 20, 2018Kinked; Unraveled Material; Kinked; Unraveled Material

  AS REPORTED BY AN AFFILIATE, THERE WAS A ¿RE-SHEATH FAILURE¿ TO A DELTAPAQ CERE COIL DELIVERY SYSTEM (CDF10021030, C38178). IT IS UNKNOWN IF THERE WAS ANY PATIENT INJURY. THE PRODUCT WILL BE RETURNED FOR ANALYSIS. PER THE PRODUCT ANALYSIS, DAMAGE WAS FOUND TO THE COIL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7356486 ↗
• MalfunctionFeb 6, 2018Positioning Failure; Kinked; Positioning Failure; Kinked

  A REPORT WAS RECEIVED THAT THE 2MM X 10CM DELTAPAQ THERMO-MECHANICAL COIL (CDF10021030/C37635) FAILED TO DETACH DURING THE PROCEDURE. ANOTHER COIL WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF CONSEQUENCE OR IMPACT TO THE PATIENT. THE PRODUCT WILL BE RETURNED FOR ANALYSIS. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7244275 ↗
• InjuryJul 14, 2017Physical Resistance; Device Operates Differently Than Expected; Physical Resistance; Device Operates Differently Than Expected

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL THAT THREE C-DELTAPAQ COILS (CDF100210-30/S10817, CDF100210-30/ S10728 X 2) AND AN ENPOWER CONTROL CABLE (ECB000182-00/S11989) WERE USED DURING A COIL EMBOLIZATION PROCEDURE OF AN ANEURYSM FOR MAPCA IN AN ABNORMAL BLOOD VESSEL OF THE PULMONARY ARTERY WHEN RESISTANCE WAS FELT BETWEEN ALL THREE C-DELTAPAQ COILS AND THE HUB OF THE MICROCATHETER. EMBOLIZATION OF THE INTERNAL THORACIC ARTERY BRANCH WAS PERFORMED DURING THE PROCEDURE FOR MAPCA. THE MICROCATHETER WAS ADVANCED TO THE TARGET LESION AND A PRE-DEPLOYMENT ELECTRICAL CHECK WAS PERFORMED. C-DELTAPAQ COIL (COMPLAINT PRODUCT 1) WAS DELIVERED THROUGH THE INTRODUCER WHICH WAS CONNECTED AT THE BACK OF THE HUB. STRONG RESISTANCE WAS FELT WHEN THE INTRODUCER WAS PASSED THROUGH THE HUB. THE COIL WAS REMOVED FROM THE MICROCATHETER AND ANOTHER C-DELTAPAQ COIL (COMPLAINT PRODUCT 2) WAS DELIVERED; HOWEVER, THE SAME ISSUE OCCURRED. THE COIL WAS REPLACED WITH A C-DELTAPAQ COIL (COMPLAINT PRODUCT 3) AND THE ISSUE OCCURRED A THIRD TIME. AFTER THAT, THE PROCEDURE WAS CONTINUED USING NON-MICRUS COILS (TARGET, STRYKER/AZUR, TERUMO CLINICAL SUPPLY). THE PATIENT WAS A (B)(6) MALE WHOSE VESSEL WAS MILDLY T

  Patient problems: No Code Available

  MAUDE report 6715476 ↗
• InjuryJul 14, 2017Physical Resistance; Device Operates Differently Than Expected; Physical Resistance; Device Operates Differently Than Expected

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL THAT THREE C-DELTAPAQ COILS (CDF100210-30/S10817, CDF100210-30/ S10728 X 2) AND AN ENPOWER CONTROL CABLE (ECB000182-00/S11989) WERE USED DURING A COIL EMBOLIZATION PROCEDURE OF AN ANEURYSM FOR MAPCA IN AN ABNORMAL BLOOD VESSEL OF THE PULMONARY ARTERY WHEN RESISTANCE WAS FELT BETWEEN ALL THREE C-DELTAPAQ COILS AND THE HUB OF THE MICROCATHETER. EMBOLIZATION OF THE INTERNAL THORACIC ARTERY BRANCH WAS PERFORMED DURING THE PROCEDURE FOR MAPCA. THE MICROCATHETER WAS ADVANCED TO THE TARGET LESION AND A PRE-DEPLOYMENT ELECTRICAL CHECK WAS PERFORMED. C-DELTAPAQ COIL (COMPLAINT PRODUCT 1) WAS DELIVERED THROUGH THE INTRODUCER WHICH WAS CONNECTED AT THE BACK OF THE HUB. STRONG RESISTANCE WAS FELT WHEN THE INTRODUCER WAS PASSED THROUGH THE HUB. THE COIL WAS REMOVED FROM THE MICROCATHETER AND ANOTHER C-DELTAPAQ COIL (COMPLAINT PRODUCT 2) WAS DELIVERED; HOWEVER, THE SAME ISSUE OCCURRED. THE COIL WAS REPLACED WITH A C-DELTAPAQ COIL (COMPLAINT PRODUCT 3) AND THE ISSUE OCCURRED A THIRD TIME. AFTER THAT, THE PROCEDURE WAS CONTINUED USING NON-MICRUS COILS (TARGET, STRYKER/AZUR, TERUMO CLINICAL SUPPLY). THE PATIENT WAS A 3-YEAR-OLD MALE WHOSE VESSEL WAS MILD

  Patient problems: No Code Available

  MAUDE report 6715449 ↗
• InjuryJul 14, 2017Physical Resistance; Device Operates Differently Than Expected; Physical Resistance; Device Operates Differently Than Expected

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL THAT THREE C-DELTAPAQ COILS (CDF100210-30/S10817, CDF100210-30/ S10728 X 2) AND AN ENPOWER CONTROL CABLE (ECB000182-00/S11989) WERE USED DURING A COIL EMBOLIZATION PROCEDURE OF AN ANEURYSM FOR MAPCA IN AN ABNORMAL BLOOD VESSEL OF THE PULMONARY ARTERY WHEN RESISTANCE WAS FELT BETWEEN ALL THREE C-DELTAPAQ COILS AND THE HUB OF THE MICROCATHETER. EMBOLIZATION OF THE INTERNAL THORACIC ARTERY BRANCH WAS PERFORMED DURING THE PROCEDURE FOR MAPCA. THE MICROCATHETER WAS ADVANCED TO THE TARGET LESION AND A PRE-DEPLOYMENT ELECTRICAL CHECK WAS PERFORMED. C-DELTAPAQ COIL (COMPLAINT PRODUCT 1) WAS DELIVERED THROUGH THE INTRODUCER WHICH WAS CONNECTED AT THE BACK OF THE HUB. STRONG RESISTANCE WAS FELT WHEN THE INTRODUCER WAS PASSED THROUGH THE HUB. THE COIL WAS REMOVED FROM THE MICROCATHETER AND ANOTHER C-DELTAPAQ COIL (COMPLAINT PRODUCT 2) WAS DELIVERED; HOWEVER, THE SAME ISSUE OCCURRED. THE COIL WAS REPLACED WITH A C-DELTAPAQ COIL (COMPLAINT PRODUCT 3) AND THE ISSUE OCCURRED A THIRD TIME. AFTER THAT, THE PROCEDURE WAS CONTINUED USING NON-MICRUS COILS (TARGET, STRYKER/AZUR, TERUMO CLINICAL SUPPLY). THE PATIENT WAS A (B)(6) MALE WHOSE VESSEL WAS MILDLY T

  Patient problems: No Code Available

  MAUDE report 6715402 ↗
• MalfunctionJan 30, 2017Positioning Failure; Positioning Failure

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A COIL EMBOLIZATION PROCEDURE A DELTAPAQ 2MM X 10CM COIL (CDF10021030/C40465) COIL COULD NOT BE DETACHED. PRE-DEPLOYMENT ELECTRICAL CHECK WAS PERFORMED AND THE GREEN SYSTEM READY LIGHT DID NOT ILLUMINATE. THE DETACHMENT LIGHT DID NOT ILLUMINATE AND THE AUDIBLE SIGNAL DID NOT BEEP. ALL CONNECTIONS APPEARED TO FIT PROPERLY WITHOUT APPLICATION OF EXCESSIVE FORCE. 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 AND WAS NOT STRETCHED. THE SAME ENPOWER CONNECTING CABLE AND ENPOWER DCB WERE USED SUCCESSFULLY WITH SUBSEQUENT COILS. THERE WAS NO REPORT ON THE PATIENT INJURY. THERE WERE NO ANY INTRA OR POST PROCEDURAL COMPLICATIONS OR SURGICAL DELAYS RELATED TO DEVICE OR REPORTED EVENT. NO DAMAGES WERE NOTED ON THE COIL, COIL DELIVERY SYSTEM OR THE DETACHMENT SYSTEM PRIOR TO USE OR AFTER REMOVAL. PATIENT INFORMATION WAS UNKNOWN. IT WAS INITIALLY REPORTED THAT THE COMPLAINT PRODUCT IS AVAILABLE FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6286162 ↗
• MalfunctionOct 13, 2016Kinked; Stretched; Physical Resistance; Kinked; Stretched; Physical Resistance

  THE CONTACT FROM THE FACILITY REPORTED THAT DURING THE COIL EMBOLIZATION, RESISTANCE WAS FELT WHEN ADVANCING THE DELTAPAQ COIL (CDF10021030/C37635) THROUGH THE MID SHAFT OF THE MICROCATHETER (DETAILS UNKNOWN.) THE USER WITHDREW THE COIL AND USED A NEW COIL WITH THE SAME CATALOG NUMBER TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF PATIENT INJURY. THERE WAS NO SIGNIFICANT DELAY TO THE PROCEDURE DUE TO THE ISSUE. THE DEVICE DID NOT KINK OR BEND AT ANY TIME PRIOR TO THE RESISTANCE/FRICTION. THE CONCOMITANT DEVICES USED WITH THE PRODUCT DID NOT KINK OR BEND AT ANY TIME. WHEN THE DEVICE WAS REMOVED FROM THE PATIENT THERE WERE NO DAMAGES ON ANY PART OF THE DEVICE. AN ADEQUATE CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE CATHETER. RETURNED PRODUCT ANALYSIS REVEALED THAT THE COIL STRETCHED AND BUCKLED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6029094 ↗
• MalfunctionOct 4, 2016Stretched; Stretched

  AS REPORTED BY A HEALTH CARE PROFESSIONAL, RESISTANCE WAS EXPERIENCED WITH THE MICROCATHETER WHEN 2 OF DELTAMAXX COILS (CDX18031230/C41165, CDX18206030/C38424) AND 2 OF C-DELTAPAQ COILS (CDF10021030/C41365) WERE BEING USED. THE PROCEDURE WAS COIL EMBOLIZATION OF AN ANEURYSM AT THE SUPERFICIAL FEMORAL ARTERY. THE PATIENT'S GENDER AND AGE WERE UNKNOWN .THE PATIENT'S VESSEL WERE NOT TORTUROUS AND NOT CALCIFIED. A CONTRALATERAL APPROACH WAS MADE WITH A GUIDING CATHETER (TYPE LOT UNKNOWN) AND MICRO CATHETER (COMPETITOR'S DEVICE). AFTER INSERTION OF SEVERAL DELTAMAXX COILS, THE C-DELTAPAQ (C41365) WAS INSERTED INTO THE MICRO CATHETER. HOWEVER THERE WAS STRONG RESISTANCE FELT AT THE MIDDLE OF THE MICRO CATHETER. THEREFORE, THE COIL WAS REPLACED WITH ANOTHER COIL (SAME SIZE, LOT# C41365); HOWEVER THE SAME ISSUE OCCURRED WITH THIS COIL. THE COIL SPLIT WHEN THE PHYSICIAN TRIED INSERTING THE COIL WITH FORCE; THE COIL WAS RETRIEVED AND WAS REPLACED WITH A DELTAMAXX (LOT UNKNOWN). AFTER PLACING SEVERAL DELTAMAXX, A DELTAMAXX CERE 3MM (LOT# C41165) WAS INSERTED; HOWEVER THERE WAS STRONG RESISTANCE AND THE COIL WAS RETRIEVED. A COMPETITOR'S COIL WAS USED INSTEAD AND PLACED IN THE LESION. FOLLOWIN

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5997580 ↗
• MalfunctionOct 4, 2016Premature Activation; Premature Activation

  AS REPORTED BY A HEALTH CARE PROFESSIONAL, RESISTANCE WAS EXPERIENCED WITH THE MICROCATHETER WHEN 2OF DELTAMAXX COILS (CDX18031230/C41165, CDX18206030/C38424) AND 2 OF C-DELTAPAQ COILS (CDF10021030/C41365) WERE BEING USED. THE PROCEDURE WAS COIL EMBOLIZATION OF AN ANEURYSM AT THE SUPERFICIAL FEMORAL ARTERY. THE PATIENT'S GENDER AND AGE WERE UNKNOWN .THE PATIENT'S VESSEL WERE NOT TORTUROUS AND NOT CALCIFIED. A CONTRALATERAL APPROACH WAS MADE WITH A GUIDING CATHETER (TYPE LOT UNKNOWN) AND MICRO CATHETER (COMPETITOR'S DEVICE). AFTER INSERTION OF SEVERAL DELTAMAXX COILS, THE C-DELTAPAQ (C41365) WAS INSERTED INTO THE MICRO CATHETER. HOWEVER THERE WAS STRONG RESISTANCE FELT AT THE MIDDLE OF THE MICRO CATHETER. THEREFORE, THE COIL WAS REPLACED WITH ANOTHER COIL (SAME SIZE, LOT# C41365); HOWEVER THE SAME ISSUE OCCURRED WITH THIS COIL. THE COIL SPLIT WHEN THE PHYSICIAN TRIED INSERTING THE COIL WITH FORCE; THE COIL WAS RETRIEVED AND WAS REPLACED WITH A DELTAMAXX (LOT UNKNOWN). AFTER PLACING SEVERAL DELTAMAXX, A DELTAMAXX CERE 3MM (LOT# C41165) WAS INSERTED; HOWEVER THERE WAS STRONG RESISTANCE AND THE COIL WAS RETRIEVED. A COMPETITOR'S COIL WAS USED INSTEAD AND PLACED IN THE LESION. FOLLOWING

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5997547 ↗