DELTAPAQ CERECYTE CDF100254-30Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00878528007135), received between Aug 29, 2016 and Nov 18, 2016 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Positioning Failure” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 18, 2016Unintended Movement; Unintended Movement

  AS REPORTED VIA A HEALTHCARE PROFESSIONAL, APPROXIMATELY THREE MONTHS AFTER PLACEMENT OF A PULSERIDER DEVICE (CATALOG 203E/W2485) FOR TREATMENT OF A 3.77CM NECK WIDTH GIANT BASILAR ARTERY ANEURYSM, FOLLOW-UP IMAGES REVEALED A SIGNIFICANT DISLOCATION OF THE PULSERIDER IN THE PROXIMAL DIRECTION. THE COIL PACKAGE WAS ALSO DISLOCATED AND SOME LOOPS OF ONE DELTAPAQ COIL (CDF 10025430/C39436) WAS LOCATED IN THE PARENT VESSEL. THE PULSERIDER HAD BEEN PREPPED AND USED AS PER THE INSTRUCTIONS FOR USE (IFU). THE DEVICE HAD BEEN INSPECTED PRIOR TO USE AND APPEARED NORMAL PRIOR TO USE. THERE HAD BEEN NO ISSUES WHEN THE DEVICE WAS FIRST IMPLANTED. IT WAS REPORTED THAT THE IMPLANTATION WAS VERY EASY AND CORRECTLY PLACED. THE ANGLES OF THE BRANCH ARTERIES WERE ABOUT 90 DEGREES. THE DEVICE HAD NOT BEEN RETRIEVED DURING THE PROCEDURE. THE COIL HAD PROTRUDED APPROXIMATELY 1.5CM INTO THE PARENT VESSEL, BUT DID NOT RESULT IN BLOOD FLOW OBSTRUCTION. THE ANEURYSM REMAINED PARTIALLY OCCLUDED WITH COILS, AND THERE WAS NO EFFORT TO PUSH THE COIL BACK INTO THE ANEURYSM. IT WAS REPORTED THAT THE PATIENT WAS DOING VERY WELL AND NO ADDITIONAL INTERVENTIONS WERE PLANNED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6113507 ↗
• MalfunctionAug 29, 2016Positioning Failure; Positioning Failure

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, 5 DELTAPAQ COILS (CDF10015230/ C37792, CDF10025430/ C36045, CDF10020430/ C36101, CDF10020330/ C40094 AND CDF10030630/ C37174) FAILED TO DETACH. THE DETACHMENT CABLE AND DCB WERE CHANGED, BUT THE COILS COULD NOT BE DETACHED. ALL OF THE COILS WERE USED IN THE SAME CASE, BUT NOT USED CONSECUTIVELY. THERE WERE NO POTENTIAL PATIENT ADVERSE EVENTS. IT WAS REPORTED THAT PRODUCT WOULD BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5910142 ↗