DELTAPAQ CERECYTE CDF100154-30Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00878528007036), received between Aug 25, 2017 and Mar 11, 2024 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Stretched” (3 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 10 most recent of 10 reports, 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 ↗
• 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 ↗
• MalfunctionAug 5, 2020Mechanical Problem; Mechanical Problem

  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 1.5MMX4CM DELTAPAQ CERE, THE EMBOLIC COIL APPEARS TO BE MECHANICALLY DETACHED FROM THE DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10369065 ↗
• MalfunctionOct 2, 2019Stretched; Physical Resistance/Sticking; Stretched; Physical Resistance/Sticking

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A COIL EMBOLIZATION, A 1.5MMX4CM DELTAPAQ CERE COIL (CDF10015430, S12651) WAS BEING USED AS THE FIRST COIL, HOWEVER, THE COIL COULDN'T BE ADVANCED NOR RETRIEVED BY THE PHYSICIAN. THE PHYSICIAN PULLED THE COIL AND THE UNKNOWN MICROCATHETER AT THE SAME TIME. AFTER INSPECTION IT TURNS OUT TO BE STRETCHED. 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 9147504 ↗
• MalfunctionJan 4, 2019Stretched; Stretched

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A COIL EMBOLIZATION OF AN INTERIOR CAROTID-POSTERIOR COMMUNICATING (IC-PC) ARTERY ANEURYSM, THE 1.5MM X 4CM DELTAPAQ (CDF10015430/S10876) THERMO-MECHANICAL COIL WAS ADVANCED TO THE TARGET VESSEL, BUT THE EMBOLIC COIL STRETCHED WHEN THE PHYSICIAN ADJUSTED IT. THE COIL WAS REPLACED WITH A COMPETITOR DEVICE, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT FURTHER INCIDENT. THE EVENT DID NOT RESULT IN A LOSS OF CEREBRAL TARGET POSITION; HOWEVER, IT WAS NOT REPORTED IF THE SAME MICROCATHETER WAS USED TO COMPLETE THE PROCEDURE. IT WAS NOT REPORTED IF THE COIL WAS SUCCESSFULLY REMOVED FROM THE PATIENT WITHOUT NEED FOR ADDITIONAL INTERVENTION. NO PATIENT COMPLICATIONS OCCURRED AS A RESULT OF THE EVENT. THE SURGERY WAS NOT DELAYED DUE TO THE EVENT. THE COMPLAINT PRODUCT WAS NEW AND STORED/HANDLED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE DEVICE WAS PACKAGED SECURELY AS EXPECTED. THERE WAS NO DAMAGE NOTED TO THE DEVICE PACKAGING OR SHIPPING CONTAINER. THE PROCEDURE WAS CONDUCTED IN ACCORDANCE WITH THE IFU. IT IS UNKNOWN IF AN ADEQUATE CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE MICROCATHETER. THERE WERE NO KINKS IN THE MICROCATHETE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8218971 ↗
• MalfunctionOct 17, 2017Kinked; Physical Resistance; Kinked; Physical Resistance

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING THE PROCEDURE, THE DELTAPAQ COIL (CDF10015430/ S10965) COULD NOT BE ADVANCED VIA THE MICROCATHETER, AND DURING ANALYSIS OF THE RETURNED PRODUCT, IT WAS FOUND THAT THE COIL WAS KINKED. THEY USED ANOTHER ONE TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF PATIENT INJURY. MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION WERE UNSUCCESSFUL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6954926 ↗
• MalfunctionSep 22, 2017Positioning Failure; Positioning Failure

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING THE ANEURYSM EMBOLIZATION PROCEDURE, THE DELTAPAQ COIL (CDF10015430/S10965) COULD NOT BE DETACHED. THEY USED ANOTHER ONE TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF PATIENT INJURY. IT WAS REPORTED THAT THE DEVICE WOULD BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6886513 ↗
• MalfunctionSep 4, 2017Positioning Failure; Positioning Failure

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING THE PROCEDURE, THE DELTAPAQ COIL (CDF10015430/ C30167) COULD NOT BE DETACHED. THEY WITHDREW THE COIL AND USED ANOTHER ONE TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6841064 ↗
• MalfunctionAug 25, 2017Kinked; Kinked

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, A KINK WAS FOUND ON THE FORE-END OF THE DELTAPAQ COIL (B)(4). THEY USED ANOTHER ONE TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF PATIENT INJURY. IT WAS REPORTED THAT THE DEVICE WOULD BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6819869 ↗