CASHMERE CERECYTE CRC140408-30Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00878528004486), received between Sep 7, 2017 and Feb 12, 2021 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Stretched” (3 reports).

1 other recall cover devices cleared under the same FDA submission (K072173); 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 12, 2021Stretched; Failure to Advance; Stretched; Failure to Advance

  THE HEALTHCARE PROFESSIONAL REPORTED THAT THE 4MM X 8CM CASHMERE 14 CERECYTE COIL (CRC14040830 / S14576) COULD NOT ADVANCE WITHIN THE CONCOMITANT MICROCATHETER DURING THE ANEURYSM EMBOLIZATION PROCEDURE. THE PHYSICIAN SWITCHED TO A NEW COIL TO COMPLETE THE PROCEDURE. IT WAS INDICATED THAT ADDITIONAL INFORMATION RELATED TO THE PROCEDURE AND DEVICE ISSUE WAS NOT OBTAINABLE. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION AS A RESULT OF THE REPORTED ISSUE. THE 4MM X 8CM CASHMERE 14 CERECYTE COIL WAS RETURNED FOR EVALUATION WHICH REVEALED THAT THE COIL WAS IN STRETCHED CONDITION. BASED ON THE PRODUCT ANALYSIS COMPLETED ON 12 FEBRUARY 2021, THIS EVENT HAS BEEN DEEMED MDR REPORTABLE AS A ¿MALFUNCTION.¿

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11324221 ↗
• MalfunctionMay 19, 2020Separation Failure; Separation Failure

  AS REPORTED BY THE FIELD, DURING A PERCUTANEOUS INTRACRANIAL ANEURYSM EMBOLIZATION COIL EMBOLIZATION, A 4MMX8.0CM CASH 14 CERE COIL (CRC14040830, S14699) COULDN¿T BE DETACHED. THE PHYSICIAN WITHDREW THE PROBLEM COIL OUTSIDE OF THE PATIENT AND CHANGED IT FOR ANOTHER NEW COIL TO COMPLETE THE PROCEDURE. THE TARGET CEREBRAL POSITION WAS NOT LOST. THERE WAS NO PATIENT INJURY REPORTED. IMAGES WERE PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10069560 ↗
• MalfunctionDec 13, 2019Stretched; Stretched

  AS REPORTED BY AN AFFILIATE, DURING A COIL EMBOLIZATION, A 4MMX8.0CM CASH 14 CERE COIL (CRC14040830, S14296) FAILED TO RESHEATH. THERE WAS NO PATIENT INJURY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED AT THE TIME OF REPORTING. BASED ON THE ANALYSIS OF THE 4MMX8.0CM CASH 14 CERE COIL, THE EMBOLIC COIL WAS FOUND STRETCHED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9468023 ↗
• MalfunctionOct 1, 2018Separation Failure; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE COIL EMBOLIZATION PROCEDURE TO TREAT AN INTRACRANIAL ANEURYSM, THE CASHMERE 14 CERECYTE COIL 4MM X 8CM COIL (CRC14040830 / S11017) COULD NOT BE DETACHED. THE COIL WAS USED WITH THE ENPOWER DETACHMENT CONTROL BOX WITH ENPOWER CONNECTING CABLE; THE SAME DCB AND CONNECTING CABLE WERE USED TO DETACH SUBSEQUENT COILS IN THE PROCEDURE. IT WAS CONFIRMED THAT A PRE-DEPLOYMENT ELECTRICAL CHECK WAS PERFORMED ON THE DETACHMENT CONTROL BOX. THE LOW BATTERY LIGHT WAS NOT SEEN, AND THE SYSTEM READY LIGHT ILLUMINATED. ALL THE CONNECTIONS WERE PROPERLY FITTED WITHOUT THE APPLICATION OF EXCESSIVE FORCE. THE COIL WAS SUCCESSFULLY REMOVED FROM THE PATIENT STILL ATTACHED TO THE DELIVERY SYSTEM; THE COIL WAS NOT STRETCHED WHEN IT WAS REMOVED. ANOTHER COIL WAS USED TO COMPLETE THE PROCEDURE. NO SIGNIFICANT CLINICAL DELAY WAS ASSOCIATED WITH THE ISSUE. THERE WAS NO REPORT OF PATIENT INJURY OR ADVERSE EVENT ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7922876 ↗
• MalfunctionSep 7, 2017Positioning Failure; Kinked; Stretched; Positioning Failure; Kinked; Stretched

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING THE PROCEDURE, THE CASHMERE COIL (CRC14040830/ S10006) COULD NOT BE DETACHED. THEY EXCHANGED THE COIL TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6849322 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K072173. 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