DELTAPAQ CERECYTERecalls & reported problems across all models

We found 20 models of DELTAPAQ CERECYTE by Medos International Sàrl in the FDA's device registry (GUDID). Together they are named in 122 adverse event reports in the FDA's MAUDE database, received between Aug 29, 2016 and Mar 11, 2024 — classified as 3 injuries, 119 malfunctions.

The most frequently reported specific device problem is “Stretched” (47 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 DELTAPAQ CERECYTE problems

DELTAPAQ CERECYTE models

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

• DELTAPAQ CERECYTE CDF100152-30

  DEVICE, NEUROVASCULAR EMBOLIZATION
  34 reports
• DELTAPAQ CERECYTE CDF100210-30

  DEVICE, NEUROVASCULAR EMBOLIZATION
  12 reports
• DELTAPAQ CERECYTE CDF100154-30

  DEVICE, NEUROVASCULAR EMBOLIZATION
  10 reports
• DELTAPAQ CERECYTE CDF100204-30

  DEVICE, NEUROVASCULAR EMBOLIZATION
  8 reports
• DELTAPAQ CERECYTE CDF100156-30

  DEVICE, NEUROVASCULAR EMBOLIZATION
  7 reports
• DELTAPAQ CERECYTE CDF100306-30

  DEVICE, NEUROVASCULAR EMBOLIZATION
  7 reports
• DELTAPAQ CERECYTE CDF100202-30

  DEVICE, NEUROVASCULAR EMBOLIZATION
  6 reports
• DELTAPAQ CERECYTE CDF100308-30

  DEVICE, NEUROVASCULAR EMBOLIZATION
  6 reports
• DELTAPAQ CERECYTE CDF100310-30

  DEVICE, NEUROVASCULAR EMBOLIZATION
  6 reports
• DELTAPAQ CERECYTE CDF100203-30

  DEVICE, NEUROVASCULAR EMBOLIZATION
  5 reports
• DELTAPAQ CERECYTE CDF100208-30

  DEVICE, NEUROVASCULAR EMBOLIZATION
  4 reports
• DELTAPAQ CERECYTE CDF100510-30

  DEVICE, NEUROVASCULAR EMBOLIZATION
  3 reports
• DELTAPAQ CERECYTE CDF100515-30

  DEVICE, NEUROVASCULAR EMBOLIZATION
  3 reports
• DELTAPAQ CERECYTE CDF100206-30

  DEVICE, NEUROVASCULAR EMBOLIZATION
  2 reports
• DELTAPAQ CERECYTE CDF100254-30

  DEVICE, NEUROVASCULAR EMBOLIZATION
  2 reports
• DELTAPAQ CERECYTE CDF100256-30

  DEVICE, NEUROVASCULAR EMBOLIZATION
  2 reports
• DELTAPAQ CERECYTE CDF100304-30

  DEVICE, NEUROVASCULAR EMBOLIZATION
  2 reports
• DELTAPAQ CERECYTE CDF100408-30

  DEVICE, NEUROVASCULAR EMBOLIZATION
  1 report
• DELTAPAQ CERECYTE CDF100616-30

  DEVICE, NEUROVASCULAR EMBOLIZATION
  1 report
• DELTAPAQ CERECYTE CDF100820-30

  DEVICE, NEUROVASCULAR EMBOLIZATION
  1 report

Recent DELTAPAQ CERECYTE adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionMar 11, 2024Break; Break

  AS REPORTED BY THE FIELD, THE PHYSICIAN OPENED THE PACKAGING OF A DELTAPAQ CERE 1.5MMX4CM COIL (CDF10015430, 30436875) FOR INSPECTION AND OBSERVED THAT THE DELIVERY WIRE WAS DAMAGED. NO ADDITIONAL INFORMATION COULD BE PROVIDED. THE DEVICE WAS NOT USED IN PATENT. A NEW COIL WAS SWITCHED TO COMPLETE THE SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18876396 ↗
• MalfunctionFeb 5, 2024Stretched; Failure to Advance; Stretched; Failure to Advance

  AS REPORTED BY THE FIELD, DURING AN ENDOVASCULAR EMBOLIZATION, A DELTAPAQ CERE 1.5MMX4CM COIL (CDF10015430, 30436875) BECAME IMPEDED IN AN UNSPECIFIED MICROCATHETER (MC) AND COULD NOT PASS THROUGH THE MC. THE PHYSICIAN REMOVED THE COIL FROM THE PATIENT AND OBSERVED THAT THE COIL WAS UNRAVELED/STRETCHED. A NEW COIL WAS SWITCHED TO COMPLETE THE SURGERY. THE MICROCATHETER WAS NOT REPLACED. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18640343 ↗
• MalfunctionFeb 5, 2024Stretched; Failure to Advance; Stretched; Failure to Advance

  AS REPORTED BY THE FIELD, DURING AN ENDOVASCULAR EMBOLIZATION, A DELTAPAQ CERE 1.5MMX2CM COIL (CDF10015230, 30432657) BECAME IMPEDED IN AN UNSPECIFIED MICROCATHETER (MC) AND COULD NOT PASS THROUGH THE MC. THE PHYSICIAN REMOVED THE COIL FROM THE PATIENT AND OBSERVED THAT THE COIL WAS UNRAVELED/STRETCHED. A NEW COIL WAS SWITCHED TO COMPLETE THE SURGERY. THE MICROCATHETER WAS NOT REPLACED. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18640125 ↗
• MalfunctionJan 30, 2024Stretched; Stretched

  AS REPORTED BY THE FIELD, DURING THE PROCEDURE, THE PHYSICIAN FILLED THE ANEURYSM WITH A DELTAPAQ CERE 2MMX4CM COIL (CDF10020430, 30436877). IT WAS FOUND THAT THE COIL WAS UNRAVELED/STRETCHED. THE PHYSICIAN RETRACTED THE COIL AND SWITCHED TO A NEW ONE TO COMPLETE THE SURGERY. THE MICROCATHETER WAS NOT REPLACED. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18609652 ↗
• MalfunctionJan 26, 2024Separation Failure; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE ENDOVASCULAR EMBOLIZATION PROCEDURE, TWO 1.5MM X 4CM DELTAPAQ 10 CERECYTE ((B)(6)) COILS WERE USED; THE FIRST COIL, FROM LOT NUMBER 30404181, THE COIL INTRODUCER CAME OFF THE DELIVERY SYSTEM. THE SECOND COIL, FROM LOT 30436875, FILLED IN THE ANEURYSM AND THE PHYSICIAN TRIED TO DETACH THE COIL, BUT THE COIL COULD NOT BE DETACHED. THE PHYSICIAN SWITCHED TO A NEW COILS TO COMPLETE THE PROCEDURE USING THE ORIGINAL MICROCATHETER. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT. ON 25-JAN-2024, PER THE CERENOVUS SALES REPRESENTATIVE, ADDITIONAL INFORMATION IS NOT AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18592500 ↗
• MalfunctionJan 18, 2024Premature Separation; Premature Separation

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE ENDOVASCULAR EMBOLIZATION PROCEDURE, THE PHYSICIAN OPENED THE DEVICE PACKAGING FOR A 1.5MM X 2CM DELTAPAQ 10 CERECYTE COIL ((B)(6)) FOR INSPECTION AND FOUND THAT THE COIL WAS SEPARATED IN THE INTRODUCER SHEATH. THE COIL WAS NOT USED IN THE PATIENT. A NEW COIL WAS USED AS REPLACEMENT TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT. ON 18-JAN-2024, PER THE CERENOVUS SALES REPRESENTATIVE, NO ADDITIONAL INFORMATION CAN BE OBTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18537126 ↗
• MalfunctionJan 17, 2024Stretched; Stretched

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE ENDOVASCULAR EMBOLIZATION PROCEDURE, THE PHYSICIAN FILLED THE ANEURYSM WITH A 1.5MM X 2CM DELTAPAQ 10 CERECYTE COIL (CDF10015230 / 30436874). IT WAS REPORTED THAT THE COIL WAS FOUND UNRAVELED / STRETCHED. THE PHYSICIAN RETRACTED THE COIL AND SWITCHED TO A NEW COIL TO COMPLETE THE PROCEDURE USING THE ORIGINAL MICROCATHETER. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT. ON 17-JAN-2024, PER THE CERENOVUS SALES REPRESENTATIVE, NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18528542 ↗
• MalfunctionJan 16, 2024Stretched; Stretched

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, TWO COILS, A DELTAPAQ CERE 1.5MMX2CM COIL (CDF10015230, 30436874) AND A DELTAPAQ CERE 1.5MMX2CM COIL (CDF10015230, 30432657) BECAME UNRAVELED/STRETCHED. A DELTAPAQ CERE 1.5MMX2CM COIL (CDF10015230, 30436874) FAILED TO DETACH. NEW COILS WERE SWITCHED TO COMPLETE THE SURGERY. THE MICROCATHETER WAS NOT REPLACED. THERE WAS NO PATIENT INJURY REPORTED. ADDITIONAL EVENT INFORMATION RECEIVED ON 10-JAN-2024 INDICATED THAT THE PRE-DEPLOYMENT ELECTRICAL TESTING WAS PERFORMED ON THE DELTAPAQ CERE 1.5MMX2CM COIL (CDF10015230, 30436874. THE SAME DETACHABLE CONTROL BOX (DCB) AND CONTROL CABLE WERE SUCCESSFULLY USED WITH SUBSEQUENT COILS. THE COIL WAS STILL ATTACHED TO THE COIL DELIVERY SYSTEM WHEN REMOVED FROM THE PATIENT. REGARDING THE UNRAVELED COILS, IT IS UNKNOWN WHEN THE COILS BECAME UNRAVELED/STRETCHED. THERE HAD BEEN NO RESISTANCE/FRICTION BETWEEN THE COIL AND ANOTHER DEVICE PRIOR TO THE DAMAGE OCCURRING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18518587 ↗
• MalfunctionJan 16, 2024Separation Failure; Separation Failure

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, TWO COILS, A DELTAPAQ CERE 1.5MMX2CM COIL (CDF10015230, 30436874) AND A DELTAPAQ CERE 1.5MMX2CM COIL (CDF10015230, 30432657) BECAME UNRAVELED/STRETCHED. A DELTAPAQ CERE 1.5MMX2CM COIL (CDF10015230, 30436874) FAILED TO DETACH. NEW COILS WERE SWITCHED TO COMPLETE THE SURGERY. THE MICROCATHETER WAS NOT REPLACED. THERE WAS NO PATIENT INJURY REPORTED. ADDITIONAL EVENT INFORMATION RECEIVED ON 10-JAN-2024 INDICATED THAT THE PRE-DEPLOYMENT ELECTRICAL TESTING WAS PERFORMED ON THE DELTAPAQ CERE 1.5MMX2CM COIL (CDF10015230, 30436874. THE SAME DETACHABLE CONTROL BOX (DCB) AND CONTROL CABLE WERE SUCCESSFULLY USED WITH SUBSEQUENT COILS. THE COIL WAS STILL ATTACHED TO THE COIL DELIVERY SYSTEM WHEN REMOVED FROM THE PATIENT. REGARDING THE UNRAVELED COILS, IT IS UNKNOWN WHEN THE COILS BECAME UNRAVELED/STRETCHED. THERE HAD BEEN NO RESISTANCE/FRICTION BETWEEN THE COIL AND ANOTHER DEVICE PRIOR TO THE DAMAGE OCCURRING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18518581 ↗
• MalfunctionJan 16, 2024Stretched; Stretched

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, TWO COILS, A DELTAPAQ CERE 1.5MMX2CM COIL, (CDF10015230, 30436874) AND A DELTAPAQ CERE 1.5MMX2CM COIL, (CDF10015230, 30432657) BECAME UNRAVELED/STRETCHED. A DELTAPAQ CERE 1.5MMX2CM COIL. (CDF10015230, 30436874) FAILED TO DETACH. NEW COILS WERE SWITCHED TO COMPLETE THE SURGERY. THE MICROCATHETER WAS NOT REPLACED. THERE WAS NO PATIENT INJURY REPORTED. ADDITIONAL EVENT INFORMATION RECEIVED ON 10-JAN-2024 INDICATED THAT THE PRE-DEPLOYMENT ELECTRICAL TESTING WAS PERFORMED ON THE DELTAPAQ CERE 1.5MMX2CM COIL (CDF10015230, 30436874. THE SAME DETACHABLE CONTROL BOX (DCB) AND CONTROL CABLE WERE SUCCESSFULLY USED WITH SUBSEQUENT COILS. THE COIL WAS STILL ATTACHED TO THE COIL DELIVERY SYSTEM WHEN REMOVED FROM THE PATIENT. REGARDING THE UNRAVELED COILS, IT IS UNKNOWN WHEN THE COILS BECAME UNRAVELED/STRETCHED. THERE HAD BEEN NO RESISTANCE/FRICTION BETWEEN THE COIL AND ANOTHER DEVICE PRIOR TO THE DAMAGE OCCURRING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18518579 ↗
• MalfunctionJan 12, 2024Separation Failure; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE ENDOVASCULAR EMBOLIZATION PROCEDURE, A 1.5MM X 2CM DELTAPAQ 10 CERECYTE COIL (CDF10015230 / 30436874) FILLED IN THE ANEURYSM AND THE PHYSICIAN TRIED TO DETACH THE COIL, BUT THE COIL COULD NOT BE DETACHED. THE PHYSICIAN RETRACTED THE COIL AND SWITCHED TO A NEW COIL TO COMPLETE THE PROCEDURE USING THE ORIGINAL MICROCATHETER. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT. IT WAS REPORTED THAT ADDITIONAL INFORMATION IS NOT AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18509185 ↗
• 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 ↗
• MalfunctionJun 10, 2022Separation Failure; Separation Failure

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, THE DOCTOR FILLED THE ANEURYSM WITH DELTAPAQ CERE 2MMX8CM COIL (CDF10020830, LOT UNKNOWN) AND PRESSED THE DETACHMENT BOX TO DETACH IT, BUT THE COIL COULD NOT BE DETACHED. THE PHYSICIAN RETRACTED THE COIL AND TO A NEW COMPETITOR¿S COIL TO COMPLETE THE SURGERY. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14652616 ↗
• MalfunctionJun 15, 2021Difficult to Advance; Difficult to Advance

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, THE PHYSICIAN TRIED TO ADVANCE A 1.5MMX2CM DELTAPAQ CERE COIL 1.5MMX2CM (CDF10015230, L15223) THROUGH AN EXCELSIOR SL10, STRYKER 45 DEGREE MICROCATHETER (MC) BUT IT WAS DIFFICULT DUE TO SOME RESISTANCE. THEREFORE, THE USER PULLED THE COMPLAINT COIL THROUGH THE MC. THERE WAS NO PATIENT INJURY, AND THE EVENT DID NOT RESULT IN A LOSS OF CEREBRAL TARGET POSITION. THERE WAS NO SURGERY DELAYED DUE TO THE REPORTED EVENT. THE COMPLAINT COIL WAS REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION. ADDITIONAL INFORMATION RECEIVED INDICATED THAT OTHER DEVICES WERE SUCCESSFULLY USED WITH THE MICROCATHETER PRIOR TO OR AFTER THE ENCOUNTERED RESISTANCE. THERE WAS NO DAMAGE TO THE MC DURING MANIPULATION OF THE DEVICE OR NOTICED TO BE DAMAGED UPON REMOVAL FROM THE PATIENT. THE COMPLAINT COIL DID NOT APPEAR TO HAVE ANY DAMAGE AT ANY TIME. THERE WAS NOTHING OBSTRUCTING THE MICROCATHETER. CONTINUOUS FLUSH ON THE MICROCATHETER WAS MAINTAINED. THE INTRODUCER WAS FLUSHED UNTIL LIQUID WAS VISIBLE AT THE DISTAL END OF THE SLIT IN THE CLEAR TUBE. THE TIP OF THE INTRODUCER WAS FIRMLY INSTALLED INTO THE HUB OF THE MICROCATHETER AND LOCKED WITH THE RHV DURING DE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12001821 ↗
• MalfunctionJan 26, 2021Device Difficult to Setup or Prepare; Material Split, Cut or Torn; Device Difficult to Setup or Prepare; Material Split, Cut or Torn

  THE HEALTHCARE PROFESSIONAL REPORTED THAT THE 5MM X 10CM DELTAPAQ 10 CERECYTE COIL (CDF10051030 / S10533) FAILED TO BE RESHEATHED AFTER THE ATTEMPT TO TRY AND CHANGE THE COIL DURING THE PROCEDURE. THE INTRODUCER SPLIT. ADEQUATE AND CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE CONCOMITANT EXCELSIOR® SL-10® MICROCATHETER (STRYKER). THERE WAS NO RESISTANCE AT ANY TIME WHEN THE COIL WAS BEING ADVANCED THROUGH THE MICROCATHETER. THERE WAS NO ISSUE WITH THE MICROCATHETER. PRIOR TO THIS ISSUE, THERE WERE OTHER COILS THAT WENT THROUGH THE SAME MICROCATHETER. THERE WAS A ONE-TO-ONE RELATIONSHIP BETWEEN THE COIL AND DELIVERY SYSTEM, AND IT WAS VERIFIED WITH FLUOROSCOPY PRIOR TO COIL REPOSITIONING. THE MICROCATHETER WAS NOT REPOSITIONED OVER THE COIL WHILE THE COIL WAS DEPLOYED / PARTIALLY DEPLOYED FROM THE DISTAL END OF THE MICROCATHETER. THE COIL WAS NOT POSITIONED AT A RELATIVELY SHARP ANGLE TO THE MICROCATHETER. THE EVENT ALSO EMPLOYED THE USE OF A STENT (UNKNOWN BRAND). THERE WAS NO BLOOD FLOW REDUCTION / RESTRICTION DUE TO THE REPORTED ISSUE WITH THE FAILED RESHEATHING. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION. THE COMPLAINT DEVICE WAS RETURNED FOR EVALUATION. DUR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11233990 ↗

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