DELTAPLUSH CERECYTE CPL100304-30Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00878528008279), received between Apr 15, 2019 and Apr 15, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Stretched” (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 16, 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.

• MalfunctionApr 15, 2019Stretched; Stretched

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE COIL EMBOLIZATION PROCEDURE, BEFORE THE COIL WAS INTRODUCED INTO THE PATIENT, WHILE UNSHEATHING THE 3 MM X 4 CM DELTAPLUSH 10 CERECYTE COIL (CPL10030430 / C32159)TO INTRODUCE INTO THE SL-10® MICROCATHETER (STRYKER), PART OF THE SHEATH CAME OFF. THE COIL WAS REMOVED FROM THE MICROCATHETER WITHOUT ANY DAMAGE NOTED ON IT. THE COIL DELIVERY SYSTEM WAS REPORTED TO HAVE BEEN PREPPED WITHOUT ANY DIFFICULTY. IT WAS CONFIRMED THAT EXCESSIVE FORCE WAS NOT APPLIED AND ADEQUATE WAS REPORTED TO HAVE BEEN MAINTAINED. THERE WAS NO DAMAGE OBSERVED ON THE MICROCATHETER; THE SAME MICROCATHETER WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF ANY PATIENT INJURY OR COMPLICATION; NO PROCEDURAL DELAY ASSOCIATED WITH THE REPORTED ISSUE. THE PRODUCT WAS RETURNED FOR EVALUATION WHICH REVEALED THAT THE COIL WAS IN A STRETCHED CONDITION. BASED ON THE PRODUCT ANALYSIS COMPLETED ON 4/15/2019, THIS EVENT HAS BEEN DEEMED MDR REPORTABLE AS A ¿MALFUNCTION.¿

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8516568 ↗

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