DELTAPLUSH CERECYTE CPL100256-30Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00878528008262), received between Sep 7, 2016 and Oct 7, 2016 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Deformation Due to Compressive Stress” (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.

• MalfunctionOct 7, 2016Kinked; Deformation Due to Compressive Stress; Kinked; Deformation Due to Compressive Stress

  THE CONTACT FROM THE FACILITY REPORTED THAT THE DELTAPLUSH COIL (CPL10025630/C24220) COULD NOT BE DETACHED AND ANOTHER DELTAPLUSH COIL (CPL10025630/C32743) COULD NOT BE RESHEATHED. THE COIL LOT C32743 WAS ATTEMPTED TO BE RESHEATHED BECAUSE IT DID NOT FIT IN THE ANEURYSM. AN EXCELSIOR SL-10 MICROCATHETER AND A 7F ENVOY GUIDE CATHETER WERE USED IN THE PROCEDURE. THE COILS WERE STORED AS STATED IN THE IFU. THERE WAS NO NOTICEABLE DAMAGE ON THE COILS OR MICROCATHETER BEFORE THE ISSUES. THE DETACHMENT CONTROL BOX & CABLE WERE USED BEFORE AND AFTER THE EVENT. IT IS NOT KNOWN WHETHER A PRE-DEPLOYMENT ELECTRICAL CHECK WAS PERFORMED. IT IS UNKNOWN WHETHER THE FAULT LIGHT WAS SEEN DURING THE CASE. AN ENPOWER DETACHMENT CONTROL BOX AND CABLE WERE USED FOR THE CASE. UPON PRESSING THE POWER BUTTON ON THE BOX ALL LIGHTS ILLUMINATED. DURING THE DETACHMENT CYCLE, THE DETACHMENT LIGHT ILLUMINATED AND THE AUDIBLE SIGNAL BEEPED. ALL CONNECTIONS APPEARED TO FIT PROPERLY WITHOUT APPLICATION OF EXCESSIVE FORCE. FAILURE ANALYSIS OF THE RETURNED PRODUCT DISCOVERED THAT THE PROXIMAL SECTION OF THE COIL LOT # C32743 WAS BUCKLED AND COMPRESSED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6011048 ↗
• MalfunctionSep 7, 2016Positioning Failure; Positioning Failure

  THE CONTACT FROM THE FACILITY REPORTED THAT THE DELTAPLUSH COIL (CPL10025630/C24220) COULD NOT BE DETACHED AND ANOTHER DELTAPLUSH COIL (CPL10025630/C32743) COULD NOT BE RESHEATHED. THE COIL LOT C32743 WAS ATTEMPTED TO BE RESHEATHED BECAUSE IT DID NOT FIT IN THE ANEURYSM. AN EXCELSIOR SL-10 MICROCATHETER AND A 7F ENVOY GUIDE CATHETER WERE USED IN THE PROCEDURE. THE COILS WERE STORED AS STATED IN THE IFU. THERE WAS NO NOTICEABLE DAMAGE ON THE COILS OR MICROCATHETER BEFORE THE ISSUES. THE DETACHMENT CONTROL BOX AND CABLE WERE USED BEFORE AND AFTER THE EVENT. IT IS NOT KNOWN WHETHER A PRE-DEPLOYMENT ELECTRICAL CHECK WAS PERFORMED. IT IS UNKNOWN WHETHER THE FAULT LIGHT WAS SEEN DURING THE CASE. AN ENPOWER DETACHMENT CONTROL BOX AND CABLE WERE USED FOR THE CASE. UPON PRESSING THE POWER BUTTON ON THE BOX ALL LIGHTS ILLUMINATED. DURING THE DETACHMENT CYCLE, THE DETACHMENT LIGHT ILLUMINATED AND THE AUDIBLE SIGNAL BEEPED. ALL CONNECTIONS APPEARED TO FIT PROPERLY WITHOUT APPLICATION OF EXCESSIVE FORCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5934909 ↗

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