DELTAPLUSH CERECYTE CPL100201-30Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00878528008187), received between Jul 19, 2017 and Jul 19, 2017 — classified as 1 malfunction.

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

1 other recall cover devices cleared under the same FDA submission (K083646); they may or may not involve this specific model.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 19, 2017Positioning Failure; Positioning Failure

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING THE PROCEDURE A DELTAPLUSH COIL (CPL10020130/C27713) FAILED TO DETACH. PRIOR TO ATTEMPT TO DETACH, IT WAS VERIFIED UNDER FLURO THAT THERE WAS NO STRESS AGAINST THE MICROCATHETER OR DELIVERY TUBE. THE PHYSICIAN ATTEMPTED TO DETACH THE COIL TEN TIMES BUT REPORTED THAT IT DID NOT WORK. A PRE-DEPLOYMENT ELECTRICAL CHECK WAS PERFORMED, THE GREEN SYSTEM READY LIGHT ILLUMINATED. DURING THE DETACHMENT CYCLE, THE DETACHMENT LIGHT ILLUMINATED AND THE AUDIBLE SIGNAL BEEPED. UNDER FLUORO THE ENTIRE COIL WAS REMOVED, HOWEVER ONLY THE PUSHER WIRE CAME OUT WITHOUT THE COIL. IT WAS THEN TRIED TO PUSH THE COIL WITH A MICROWIRE BUT THERE SEEMED TO BE NO COIL IN THE MICROCATHETER AS IT COULD NOT BE SEEN UNDER FLUORO. THE MICROCATHETER WAS IN THE ANEURYSM WHEN THIS EVENT OCCURRED. THE LOCATION OF THE COIL IS UNKNOWN. THE PROCEDURE WAS COMPLETED WITH A SAME LIKE PRODUCT WITH A DELAY OF 15 MINUTES. THE SAME CONNECTING CABLE AND DCB WERE USED SUCCESSFULLY WITH SUBSEQUENT COIL. THE PROCEDURE WAS FOR RE-TREATMENT OF MIDDLE CEREBRAL ARTERY ANEURYSM WHICH WAS INITIALLY TREATED WITH A WEB DEVICE WITH INSUFFICIENT RESULTS. THE RE-TREATMENT AS PERFORMED USING BAB

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6725605 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K083646. One submission often covers many models, so check the product and lot details in each record.

• Z-0845-2011 · Oct 21, 2010 · Terminated
  Micrus Endovascular Microcoil Delivery System; The Micrus Microcoil Delivery System consists of three components, a Microcoil System, a Connecting Cable, and a Detachment Control B