DELTAPLUSH CERECYTE CPL100408-30Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00878528008316), received between Jul 9, 2018 and Jul 9, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Twisted/Bent” (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 9, 2018Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL THAT DURING AN ANEURYSM EMBOLIZATION PROCEDURE, THE PHYSICIAN WAS UNABLE TO ADVANCE A DELTAPLUSH COIL (CPL10040830/S11187) IN THE MICROCATHETER AND THE PHYSICIAN FELT THAT THE DEVICE MIGHT HAVE BEEN DAMAGED. THE PHYSICIAN DECIDED NOT TO PUT THIS DEVICE IN THE PATIENT AND USED ANOTHER DEVICE WITHOUT ANY ISSUES. THERE WERE NO PATIENT CONSEQUENCES OR DELAY IN PROCEDURE AS A RESULT OF THIS EVENT. THERE WAS NO DAMAGE NOTED TO THE DEVICE PRIOR TO THE PROCEDURE. A SL10 STRYKER MICROCATHETER WAS USED DURING THE PROCEDURE AND NO KINKS OR BENDS WERE NOTED TO THE MICROCATHETER THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. THERE WERE NO OTHER DEVICES USED WITH THE MICROCATHETER PRIOR TO THE EVENT. AN ADEQUATE CONTINUOUS FLUSH WAS NOT MAINTAINED THROUGH THE CATHETER AT ALL TIMES. NOTE: THIS EVENT WAS DEEMED MDR REPORTABLE BASED ON DEVICE EVALUATION RESULTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7672374 ↗

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