CASHMERE CERECYTE CRC140225-30Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00878528004400), received between Nov 16, 2016 and Apr 1, 2019 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Positioning Failure” (2 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.

• MalfunctionApr 1, 2019Material Twisted/Bent; Material Twisted/Bent

  THE HEALTHCARE PROFESSIONAL REPORTED THAT THE DURING THE PROCEDURE, THE 2MM X 2.5CM CASHMERE 14 CERECYTE COIL (CRC14022530 / LOT#: UNKNOWN) HAD ISSUE WITH RESHEATHING / REZIPPING. THE REPORTED EVENT DID NOT RESULT IN ANY PROCEDURAL DELAY AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO REPORT OF ANY PATIENT INJURY OR COMPLICATION. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION RELATED TO THE PROCEDURE AND THE REPORTED DEVICE WERE UNSUCCESSFUL. IF ADDITIONAL INFORMATION IS RECEIVED AT A LATER DATE, THIS FILE WILL BE UPDATED ACCORDINGLY. THE 2MM X 2.5CM CASHMERE 14 CERECYTE COIL WAS RETURNED FOR EVALUATION WHICH REVEALED THAT THE EMBOLIC COIL WAS KINKED. BASED ON THE PRODUCT ANALYSIS COMPLETED ON 4/1/2019, THIS EVENT HAS BEEN DEEMED MDR REPORTABLE AS A ¿MALFUNCTION.¿

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8471752 ↗
• MalfunctionJul 23, 2018Separation Failure; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE PROCEDURE, THE CASHMERE 14 CERECYTE COIL 2MM X 2.5CM (B)(4) COULD NOT BE DETACHED. THE COIL WAS WITHDRAWN AND ANOTHER COIL WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF ANY PATIENT INJURY OR CONSEQUENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7712765 ↗
• MalfunctionDec 22, 2017Positioning Failure; Positioning Failure

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A COIL EMBOLIZATION OF AN INTRACRANIAL ANEURYSM, A 2 MM X 2.5 CM CASHMERE THERMO-MECHANICAL MICROCROIL (CRC14022530/C29515) COULD NOT BE DETACHED. THE COIL WAS SUCCESSFULLY REMOVED FROM THE PATIENT AND ANOTHER COIL WAS USED TO COMPLETE THE CASE. THE SAME ENPOWER DETACHMENT CONTROL BOX AND CONNECTING CABLE WERE USED TO DETACH SUBSEQUENT COILS. THE COIL WAS STILL ATTACHED TO THE DELIVERY SYSTEM WHEN REMOVED FROM THE PATIENT AND THE COIL WAS NOT STRETCHED WHEN IT WAS REMOVED. THERE WAS NO REPORT OF PATIENT INJURY. A PRE-DEPLOYMENT ELECTRICAL CHECK WAS PERFORMED. THE GREEN SYSTEM READY LIGHT ILLUMINATED. NEITHER A LOW BATTERY LIGHT NOR A FAULT LIGHT WERE VISUALIZED DURING THE CASE. ALL CONNECTIONS APPEARED TO FIT PROPERLY WITHOUT APPLICATION OF EXCESSIVE FORCE. IT IS UNKNOWN IF ALL LIGHTS ILLUMINATED WHEN THE POWER BUTTON WAS PRESSED. IT IS ALSO UNKNOWN IF THE DETACHMENT LIGHT ILLUMINATED AND THE AUDIBLE SIGNAL BEEPED DURING THE DETACHMENT CYCLE. THE PRODUCT WILL BE RETURNED FOR ANALYSIS. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7144055 ↗
• MalfunctionOct 13, 2017Positioning Failure; Positioning Failure

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING THE PROCEDURE, THE CASHMERE COIL (CRC14022530/M10553) COULD NOT BE DETACHED. THEY USED ANOTHER ONE TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF PATIENT INJURY. IT WAS REPORTED THAT THE DEVICE WOULD BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6947134 ↗
• MalfunctionNov 16, 2016Difficult To Position; Difficult To Position

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING COIL EMBOLIZATION OF AN UNSPECIFIED ANEURYSM, THE CASHMERE COIL (CRC14022530/C25010) COULD NOT BE SHAPED COMPLETELY. THERE WAS DIFFICULTY GETTING THE COIL TO CONFORM TO THE WALL OF THE ANEURYSM. THEY WITHDREW THE COIL WITHOUT DIFFICULTY AND USED A NEW COIL TO COMPLETE THE PROCEDURE. THIS WAS THE FIRST COIL TO BE IMPLANTED. THERE WAS NO REPORT OF RESISTANCE BETWEEN THE CASHMERE AND THE UNSPECIFIED MICROCATHETER. AFTER REMOVAL OF THE COIL FROM THE PATIENT, IT DID NOT APPEAR DAMAGED (I.E. STRETCHED, KINKED COMPRESSED, SEPARATED OR DETACHED). THERE WAS NO REPORT OF PATIENT INJURY OR CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. IT WAS REPORTED THAT THE DEVICE WOULD BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6106451 ↗

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