DELTAPLUSH CERECYTE CPL100306-30Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00878528008286), received between Jul 13, 2017 and Jan 29, 2019 — classified as 2 malfunctions.

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 16, 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.

• MalfunctionJan 29, 2019Stretched; Material Twisted/Bent; Stretched; Material Twisted/Bent

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE PROCEDURE WITH TARGET VESSEL UNKNOWN, A DISTAL KINK WAS FOUND ON THE 6F, 100 CM, MPD, XB ENVOY® GUIDING CATHETER (67025800B/30019773), AND AS A RESULT OF THE KINK, THE 3 MM X 6 CM DELTAPLUSH 10 CERECYTE COIL (CPL10030630/C38446) WAS UNABLE TO ADVANCE THROUGH THE GUIDING CATHETER. THE DEVICES WERE REPLACED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF PATIENT CONSEQUENCE, ADVERSE EVENT OR ANY PROCEDURAL DELAY ASSOCIATED WITH THE REPORTED ISSUES. THE 3 MM X 6 CM DELTAPLUSH 10 CERECYTE COIL WAS RETURNED FOR EVALUATION WHICH REVEALED THAT THE COIL WAS KINKED AND STRETCHED. BASED ON THE PRODUCT ANALYSIS COMPLETED ON 1/29/2019, THIS EVENT HAS BEEN DEEMED MDR REPORTABLE AS A ¿MALFUNCTION.¿

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8287664 ↗
• MalfunctionJul 13, 2017Positioning Failure; Positioning Failure

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING COIL EMBOLIZATION OF AN IMA ARTERY, A DELTAPLUSH COIL (CPL10030630/ C26878) FAILED TO DETACH. INITIALLY A 3MM X 6CM DELTAPLUSH COIL WAS DETACHED WITHOUT ANY PROBLEM. THE PHYSICIAN TIED TO DETACH THE COMPLAINT DELTAPLUSH AS THE SECOND COIL, BUT DETACHMENT ERROR OCCURRED FOR 4 TIMES. THE COIL WAS REPLACED WITH ANOTHER ONE (PRESIDIO10) TO COMPLETE EMBOLIZATION. A CORSAIR PV MICROCATHETER WAS USED FOR THE PROCEDURE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT FURTHER ISSUES OR DELAY. THERE WAS ALSO NO PATIENT INJURY / COMPLICATION REPORTED. THE COMPLAINT PRODUCT WAS NEW AND STORED PER LABELING INSTRUCTIONS. THE PROCEDURE WAS CONDUCTED IN ACCORDANCE WITH THE IFU AND THE CONSTANT FLUSH HAD BEEN MAINTAINED AT ALL TIME. NO VISIBLE DEFECT/DAMAGE WAS NOTED ON THE PRODUCTS PRIOR TO THE EVENT. NO UNINTENDED DETACHMENT WAS OBSERVED IN THE VESSEL OR IN THE MICROCATHETER. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6711795 ↗

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