DELTAPLUSH CERECYTERecalls & reported problems across all models

We found 12 models of DELTAPLUSH CERECYTE by Medos International Sàrl in the FDA's device registry (GUDID). Together they are named in 67 adverse event reports in the FDA's MAUDE database, received between Aug 30, 2016 and Aug 4, 2022 — classified as 67 malfunctions.

The most frequently reported specific device problem is “Positioning Failure” (15 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported DELTAPLUSH CERECYTE problems

DELTAPLUSH CERECYTE models

12 models, most reported first. Each model has its own page with its reports, recalls and device details.

• DELTAPLUSH CERECYTE CPL100153-30

  DEVICE, NEUROVASCULAR EMBOLIZATION
  20 reports
• DELTAPLUSH CERECYTE CPL100151-30

  DEVICE, NEUROVASCULAR EMBOLIZATION
  14 reports
• DELTAPLUSH CERECYTE CPL100152-30

  DEVICE, NEUROVASCULAR EMBOLIZATION
  9 reports
• DELTAPLUSH CERECYTE CPL100206-30

  DEVICE, NEUROVASCULAR EMBOLIZATION
  7 reports
• DELTAPLUSH CERECYTE CPL100204-30

  DEVICE, NEUROVASCULAR EMBOLIZATION
  5 reports
• DELTAPLUSH CERECYTE CPL100203-30

  DEVICE, NEUROVASCULAR EMBOLIZATION
  3 reports
• DELTAPLUSH CERECYTE CPL100202-30

  DEVICE, NEUROVASCULAR EMBOLIZATION
  2 reports
• DELTAPLUSH CERECYTE CPL100256-30

  DEVICE, NEUROVASCULAR EMBOLIZATION
  2 reports
• DELTAPLUSH CERECYTE CPL100306-30

  DEVICE, NEUROVASCULAR EMBOLIZATION
  2 reports
• DELTAPLUSH CERECYTE CPL100201-30

  DEVICE, NEUROVASCULAR EMBOLIZATION
  1 report
• DELTAPLUSH CERECYTE CPL100304-30

  DEVICE, NEUROVASCULAR EMBOLIZATION
  1 report
• DELTAPLUSH CERECYTE CPL100408-30

  DEVICE, NEUROVASCULAR EMBOLIZATION
  1 report

Recent DELTAPLUSH CERECYTE adverse event reports

The 15 most recent reports across all models, 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 ↗
• MalfunctionJun 21, 2021Device Difficult to Setup or Prepare; Material Split, Cut or Torn; Device Difficult to Setup or Prepare; Material Split, Cut or Torn

  AS REPORTED BY THE FIELD, THE PHYSICIAN TRIED TO RESHEATH A DELTAPL CERE COIL 10 SYS 1.5X3 COIL (CPL10015330, L15233) AFTER DECIDING THAT THE CHOSEN COIL WAS AN UNPROPER CHOICE DURING THE PROCEDURE. HOWEVER, THE RESHEATH FAILED AND INTRODUCER SHEATH WAS ¿SPLIT¿. THERE WAS NO SURGERY DELAY DUE TO THE REPORTED EVENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT INJURY. THE ONLY THE COMPLAINT COIL WAS REMOVED EASILY FROM THE PATIENT WITHOUT ADDITIONAL INTERVENTION. ADEQUATE CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE UNSPECIFIED MICROCATHETER (MC). THERE WAS NO RESISTANCE AT ANY TIME DURING ADVANCEMENT OF THE COIL THROUGH THE MC. BASED ON THE DEVICE ANALYSIS, THE EMBOLIC COIL WAS OBSERVED STRETCHED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12036798 ↗
• MalfunctionFeb 10, 2021Device Difficult to Setup or Prepare; Stretched; Material Split, Cut or Torn; Device Difficult to Setup or Prepare; Stretched; Material Split, Cut or Torn

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE PROCEDURE, THE PHYSICIAN ATTEMPTED TO RESHEATH THE 1.5MM X 3CM DELTAPLUSH 10 CERECYTE COIL (CPL10015330 / L15226) AFTER DECIDING THAT THE COIL WAS NOT THE PROPER CHOICE FOR THE PROCEDURE, BUT THE COIL FAILED TO RESHEATH AND THE INTRODUCER SHEATH BECAME SPLIT. THERE WAS NO RESISTANCE BETWEEN THE COMPLAINT COIL AND THE CONCOMITANT EXCELSIOR® SL-10® MICROCATHETER (STRYKER); THERE WAS NO ISSUE WITH THE MICROCATHETER. THE COIL WAS REMOVED FROM THE PATIENT WITHOUT ANY INTERVENTION AND WITHOUT LOSS OF TARGET POSITION. THERE WAS NO BLOOD FLOW RESTRICTION / REDUCTION AS A RESULT OF THE REPORTED EVENT. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION. THE COMPLAINT DEVICE WAS RETURNED FOR EVALUATION. DURING THE VISUAL / MICROSCOPIC INSPECTION OF THE RETURNED DEVICE, THE EMBOLIC COIL WAS OBSERVED IN STRETCHED CONDITION AND MECHANICALLY DETACHED. BASED ON THE PRODUCT ANALYSIS ON 10 FEBRUARY 2021, THIS EVENT HAS BEEN DEEMED MDR REPORTABLE AS A ¿MALFUNCTION.¿

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11311793 ↗
• MalfunctionSep 9, 2020Positioning Problem; Positioning Problem

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, A DELTAPL CERE COIL 10 SYS 1.5X1 (CPL10015130, S11750) WAS BEING USED AS A FILLING COIL. THE PHYSICIAN DIDN'T LIKE THE SHAPE OF THE COIL DEPLOYMENT, AND DECIDED TO PULL IT OUT. DURING THE RESHEATHING OF THE COIL, THE INTRODUCER FAILED TO BE RE-ZIPPED. THE PHYSICIAN USED A SAME LIKE PRODUCT. THE PROCEDURE WAS SUCCESSFULLY FINISHED. THERE WAS NO REPORT OF PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10507800 ↗
• MalfunctionAug 11, 2020Positioning Problem; Positioning Problem

  THE HEALTHCARE PROFESSIONAL REPORTED THAT THE 1.5MM X 1CM DELTAPLUSH 10 CERECYTE COIL (CPL10015130 / C38361) WAS CHOSEN AS THE FINISHING COIL FOR THE PROCEDURE; IT WAS REPORTED THAT THE PHYSICIAN DID NOT LIKE THE SHAPE OF THE COIL DEPLOYMENT AND DECIDED TO REMOVE THE COIL. DURING THE RESHEATHING ATTEMPT, THE COIL INTRODUCER FAILED TO BE RE-ZIPPED. THE PHYSICIAN USED ANOTHER 1.5MM X 1CM DELTAPLUSH 10 CERECYTE COIL AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10393925 ↗
• MalfunctionMar 17, 2020Positioning Problem; Positioning Problem

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE PROCEDURE, THE PHYSICIAN DID NOT LIKE THE SHAPE OF THE 1.5MM X 1CM DELTAPLUSH 10 CERECYTE COIL (CPL10015130 / S12610) DEPLOYMENT AND DECIDED TO REMOVE THE COIL. DURING THE RESHEATHING ATTEMPT, THE COIL INTRODUCER FAILED TO BE RE-ZIPPED. THE PHYSICIAN USED ANOTHER 1.5MM X 1CM DELTAPLUSH 10 CERECYTE COIL AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9844878 ↗
• MalfunctionMar 16, 2020Positioning Problem; Positioning Problem

  THE HEALTHCARE PROFESSIONAL REPORTED THAT THE 1.5MM X 1CM DELTAPLUSH 10 CERECYTE COIL (CPL10015130 / S14367) WAS USED IN THE PROCEDURE; IT WAS REPORTED THAT THE PHYSICIAN DID NOT LIKE THE SHAPE OF THE COIL DEPLOYMENT AND DECIDED TO REMOVE THE COIL. DURING THE RESHEATHING ATTEMPT, THE COIL INTRODUCER FAILED TO BE RE-ZIPPED. THE PHYSICIAN USED ANOTHER 1.5MM X 1CM DELTAPLUSH 10 CERECYTE COIL AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9836843 ↗
• MalfunctionDec 16, 2019Material Deformation; Material Deformation

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A COIL EMBOLIZATION A 1.5X2 DELTAPL CERE COIL 10 SYS (CPL10015230, S14634) COULD NOT BE ADVANCED NOR RETRIEVED BY THE PHYSICIAN. THERE WAS NO PATIENT INJURY REPORTED. THE COMPLAINT DEVICE WAS REPLACED TO COMPLETE THE PROCEDURE AND THE PATIENT OUTCOME WAS ¿GOOD¿. THE COIL WAS BEING USED AS THE LAST COIL (5TH). ADEQUATE AND CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE CATHETER. WHEN THE COIL WAS REMOVED FROM THE PATIENT, THERE WAS NO DAMAGES ON ACTUAL COIL OR OTHER PARTS OF THE DEVICE. ONLY DAMAGE WAS TO THE SHEATH INTRODUCER. THE SAME MICROCATHETER WAS USED TO COMPLETE THE PROCEDURE. PICTURES WERE RECEIVED. BASED ON THE DEVICE ANALYSIS, THE EMBOLIC COIL WAS DAMAGED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9475532 ↗
• MalfunctionDec 5, 2019Stretched; Stretched

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A COIL EMBOLIZATION, A 1.5X3 DELTAPL CERE 10 COIL FAILED TO RESHEATHED. NO ADDITIONAL INFORMATION WAS PROVIDED. BASED ON THE ANALYSIS OF THE DEVICE RECEIVED, THE COIL WAS FOUND STRETCHED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9418367 ↗
• MalfunctionOct 24, 2019Stretched; Stretched

  THE HEALTHCARE PROFESSIONAL REPORTED THAT THE 1.5MM X 1CM DELTAPLUSH 10 CERECYTE COIL (CPL10015130 / S14368) WAS THE FIRST COIL USED DURING THE PROCEDURE. THE PHYSICIAN REPORTED THAT STRONG RESISTANCE WAS FELT DURING THE ADVANCEMENT OF THE COIL THROUGH THE PROWLER MICROCATHETER (UNKNOWN CATALOG/LOT NUMBER) AT THE DISTAL AREA OF THE MICROCATHETER. THE COIL WAS REPLACED, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION. THE 1.5MM X 1CM DELTAPLUSH 10 CERECYTE COIL WAS RETURNED FOR EVALUATION WHICH REVEALED THAT THE EMBOLIC COIL WAS STRETCHED. BASED ON THE PRODUCT ANALYSIS ON 10/23/2019, THIS EVENT HAS BEEN DEEMED MDR REPORTABLE AS A ¿MALFUNCTION.¿

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9236164 ↗
• MalfunctionAug 13, 2019Stretched; Separation Failure; Stretched; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE PROCEDURE, THE PHYSICIAN ATTEMPTED TO DETACH THE 1.5MM X 3CM DELTAPLUSH 10 CERECYTE COIL (CPL10015330 / C27603), THE AUDIBLE BEEP OF THE DETACHMENT CYCLE WAS HEARD AS EXPECTED, BUT DURING THE RETRIEVAL ATTEMPT OF THE DELIVERY SYSTEM, THE COIL BECAME PROTRUDED FROM THE INTRODUCER SHEATH. ANOTHER 1.5MM X 3CM DELTAPLUSH 10 CERECYTE COIL WAS USED AS A REPLACEMENT COIL AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO REPORT OF ANY PATIENT COMPLICATION OR ADVERSE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8889430 ↗
• MalfunctionJul 22, 2019Separation Failure; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE COIL EMBOLIZATION, THE 1.5MM X 2CM DELTAPLUSH 10 CERECYTE COIL (CPL10015230 / S13546) COULD NOT BE DETACHED. THE COIL WAS WITHDRAWN, AND ANOTHER COIL WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF PATIENT INJURY OR COMPLICATION. IT WAS REPORTED THAT THE PRODUCT IS AVAILABLE TO BE RETURNED FOR EVALUATION AND ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8812559 ↗
• MalfunctionApr 24, 2019Stretched; Material Deformation; Stretched; Material Deformation

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE COIL EMBOLIZATION PROCEDURE TO TREAT AN ANEURYSM AT AN UNKNOWN TARGET SITE, THE 1.5MM X 3CM DELTAPLUSH 10 CERECYTE COIL (CPL10015330 / S14308) BECAME IMPEDED IN THE ECHELON® 10 MICROCATHETER (MEDTRONIC) AND COULD NOT BE ADVANCED IN THE MICROCATHETER; AS A RESULT, THE PROTECTIVE SHEATH BECAME DAMAGED; THE COIL INTRODUCER WAS NOT DAMAGED. ANOTHER 1.5MM X 3CM DELTAPLUSH 10 CERECYTE COIL FROM THE SAME LOT WAS USED AND THE SAME ISSUE WAS ENCOUNTERED. A THIRD COIL, A 1.5 MM X 3 CM AXIUM¿ COIL (MEDTRONIC) WAS USED AND WAS SUCCESSFULLY IMPLANTED. THERE WAS NO LOSS OF TARGET POSITION; THE REPORTED EVENT DID NOT REQUIRE THAT THE COIL AND THE MICROCATHETER BE REMOVED TOGETHER AS A UNIT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT ANY PATIENT INJURY, COMPLICATION AND WITHOUT ANY DELAY. THE COMPLAINT PRODUCT WAS NEW AND WAS STORED PER LABELING INSTRUCTIONS. THE PROCEDURE WAS CONDUCTED IN ACCORDANCE WITH THE INSTRUCTION FOR USE (IFU) WITH CONSTANT FLUSH MAINTAINED AT ALL TIME. THE PRODUCTS WERE RETURNED FOR EVALUATION WHICH REVEALED THAT ONE OF THE 1.5MM X 3CM DELTAPLUSH 10 CERECYTE COILS WAS IN A DAMAGED CONDITION. BASED ON THE PRODUCT A

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8547440 ↗
• MalfunctionApr 15, 2019Stretched; Stretched

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE COIL EMBOLIZATION PROCEDURE, BEFORE THE COIL WAS INTRODUCED INTO THE PATIENT, WHILE UNSHEATHING THE 3 MM X 4 CM DELTAPLUSH 10 CERECYTE COIL (CPL10030430 / C32159)TO INTRODUCE INTO THE SL-10® MICROCATHETER (STRYKER), PART OF THE SHEATH CAME OFF. THE COIL WAS REMOVED FROM THE MICROCATHETER WITHOUT ANY DAMAGE NOTED ON IT. THE COIL DELIVERY SYSTEM WAS REPORTED TO HAVE BEEN PREPPED WITHOUT ANY DIFFICULTY. IT WAS CONFIRMED THAT EXCESSIVE FORCE WAS NOT APPLIED AND ADEQUATE WAS REPORTED TO HAVE BEEN MAINTAINED. THERE WAS NO DAMAGE OBSERVED ON THE MICROCATHETER; THE SAME MICROCATHETER WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF ANY PATIENT INJURY OR COMPLICATION; NO PROCEDURAL DELAY ASSOCIATED WITH THE REPORTED ISSUE. THE PRODUCT WAS RETURNED FOR EVALUATION WHICH REVEALED THAT THE COIL WAS IN A STRETCHED CONDITION. BASED ON THE PRODUCT ANALYSIS COMPLETED ON 4/15/2019, THIS EVENT HAS BEEN DEEMED MDR REPORTABLE AS A ¿MALFUNCTION.¿

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8516568 ↗

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