CASHMERE CERECYTE CRC140304-30Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00878528004424), received between Sep 21, 2017 and Nov 9, 2021 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Separation 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 9, 2021Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION OF THE INFERIOR CEREBELLAR ARTERY (ICA), THE PHYSICIAN DECIDED TO PULL OUT A CASH 14 CERE COIL 3MMX4.0CM (CRC14030430, S14375) BECAUSE IT¿S SIZE WAS NOT APPROPRIATE WITH ANEURYSM. DURING RESHEATHING OF THE COIL, IT WAS FAILED TO BE RE-ZIPPED. THERE WAS NO SURGERY DELAYED DUE TO THE REPORTED EVENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. ADDITIONAL INFORMATION RECEIVED INDICATED THAT AN ADEQUATE CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE UNSPECIFIED MICROCATHETER (MC). THE DELIVERY WIRE WAS NOT PROTRUDING FROM THE INTRODUCER. THERE WAS NO DAMAGE NOTED TO THE SHEATH INTRODUCER. THERE WAS NO SPLIT. THERE WAS NO RESISTANCE AT ANY TIME DURING ADVANCEMENT OF THE COIL THROUGH THE MC. IT WAS NOT NECESSARY TO REMOVE THE MICROCATHETER. NO ADDITIONAL INTERVENTION WAS REQUIRED. THERE WAS NO BLOOD FLOW RESTRICTION/REDUCTION AS A RESULT OF THE EVENT. BASED ON THE ANALYSIS OF THE DEVICE RECEIVED, THE EMBOLIC COIL IS STRETCHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12778139 ↗
• MalfunctionJan 11, 2019Separation Failure; Material Integrity Problem; Separation Failure; Material Integrity Problem

  A REPORT WAS RECEIVED THAT DURING A COIL EMBOLIZATION, THE 2.5MM X 6CM ULTIPAQ 10 (FSR10025620/C27367) AND 3MM X 4CM CASHMERE 14 (CRC14030430/S10171) COILS COULD NOT BE DEPLOYED. THE COILS WERE REMOVED EASILY WITHOUT THE NEED FOR ADDITIONAL INTERVENTION. THE COILS WERE REPLACED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE SURGERY WAS NOT DELAYED DUE TO THE EVENT. NO PATIENT COMPLICATIONS OCCURRED AS A RESULT OF THE EVENT. THE PRODUCTS WILL BE RETURNED FOR EVALUATION. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8241656 ↗
• MalfunctionAug 20, 2018Separation Failure; Material Deformation; Separation Failure; Material Deformation

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, THE PHYSICIAN ATTEMPTED TO DETACH THE 3 MM X 4.0 CM CASHMERE 14 (CRC14030430/UNK LOT) THERMO-MECHANICAL COIL BUT THE COIL FAILED TO DETACH. THE COIL WAS REMOVED FROM THE PATIENT WITHOUT DIFFICULTY AS IT WAS THE FIRST COIL USED IN THE CASE. THERE WAS NO REPORT OF CONSEQUENCE OR IMPACT TO THE PATIENT. IT WAS REPORTED THAT THE INFORMATION PROVIDED FOR THIS COMPLAINT WAS ALL OF THE DETAILS THAT WERE KNOWN/AVAILABLE REGARDING THIS EVENT. THE PRODUCT WILL BE RETURNED FOR EVALUATION. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7797304 ↗
• MalfunctionSep 21, 2017Stretched; Stretched

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL THAT A CASHMERE COIL ( CRC14030430/C27378) STRETCHED DURING AN ANEURYSM EMBOLIZATION PROCEDURE. ANOTHER COIL WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6883873 ↗

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