DELTAPAQ CERECYTE CDF100510-30Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00878528007296), received between May 10, 2017 and Jan 26, 2021 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Stretched” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• MalfunctionAug 8, 2019Stretched; Stretched

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A COIL EMBOLIZATION, A 2.5MMX6CM DELTAPAQ CERE (CDF10025630, LOT UNKNOWN), A 3MMX6CM DELTAPAQ CERECYTE (CDF10030630, LOT UNKNOWN) AND A 5MMX10CM DELTAPAQ CERE (CDF10051030, S11295) WERE NOT ABLE TO ADVANCE NOR RETRIEVED BY THE PHYSICIAN. THE PHYSICIAN PULLED THE COILS AND MICROCATHETER (MC) 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 PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8874318 ↗
• MalfunctionMay 10, 2017Stretched; Stretched

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, AN ENVOY DA CATHETER (67125805D/ E11363) WAS KINKED WHEN IT WAS FIRST OPENED, A DELTAPAQ INTRODUCER (CDF10051030/ C38958) FAILED TO RE-ZIP DURING RE-SHEATHING AND WAS FOUND TO BE STRETCHED DURING PRODUCT ANALYSIS, AND THERE WAS RESISTANCE DURING ADVANCEMENT OF A PRESIDIO COIL (PC410073030/ C37141) THROUGH THE UNSPECIFIED MICROCATHETER AND THE DEVICE WAS RETURNED WITH THE COIL PREMATURELY DETACHED. THE PHYSICIAN DID NOT LIKE THE SHAPE OF COIL DEPLOYMENT AND DECIDED TO PULL IT OUT, BUT DURING RE-SHEATHING THE COIL INTRODUCER FAILED TO RE-ZIP. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH SAME/LIKE PRODUCTS. THERE WERE NO POTENTIAL ADVERSE EVENTS. AFTER MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION, NO INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6556765 ↗