CASHMERE CERECYTE CRC140306-30Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00878528004448), received between Mar 23, 2017 and Jul 9, 2019 — classified as 6 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 9, 2019Stretched; Separation Failure; Stretched; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE PROCEDURE, THE 3MM X 6CM CASHMERE 14 CERECYTE COIL (CRC14030630 / S14435) COULD NOT BE DETACHED. THE COIL WAS WITHDRAWN, AND THE PROCEDURE WAS COMPLETED USING ANOTHER 3MM X 6CM CASHMERE 14 CERECYTE COIL (CRC14030430) AND A 2MM X 4 CM DELTAPAQ 10 CERECYTE COIL (CDF10020430). THERE WAS NO REPORT OF PATIENT INJURY OR COMPLICATION. IT WAS REPORTED THAT THE PRODUCT IS AVAILABLE TO BE RETURNED FOR EVALUATION AND ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8773437 ↗
• MalfunctionFeb 5, 2019Stretched; Material Twisted/Bent; Physical Resistance/Sticking; Stretched; Material Twisted/Bent; Physical Resistance/Sticking

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE INTERVENTIONAL EMBOLIZATION OF A POSTERIOR COMMUNICATION ARTERY ANEURYSM, THE FIRST TWO COILS: A 5 MM X 17 CM PRESIDIO 10 CERECYTE (PC410051730 / S12276) AND A 2 MM X 6 CM DELTAPAQ 10 CERECYTE (CDF10020630 / S37678) ADVANCED SMOOTHLY WITHOUT ANY ISSUE THROUGH THE 150 CM PROWLER14 MICROCATHETER (606151X / LOT# UNKNOWN). THE THIRD COIL CHOSEN WAS THE 3 MM X 6 CM CASHMERE 14 CERECYTE COIL (CRC14030630 / S13696). WHEN THE PHYSICIAN ATTEMPTED TO ADVANCE THIS COIL TO THE TARGET SITE FOR IMPLANTATION, HE FOUND IT HARD TO PUSH THE COIL IN THE MICROCATHETER. IT WAS ALSO HARD TO PULL THE COIL BACK OUT FROM THE MICROCATHETER. THE PHYSICIAN COULD ONLY PULL THE CASHMERE 14 CERECYTE COIL OUT WITH THE PROWLER 14 MICROCATHETER. THE EVENT RESULTED IN THE LOSS OF THE TARGET SITE AS BOTH THE COIL AND THE MICROCATHETER WERE REPLACED. THE PROCEDURE WAS COMPLETED USING ANOTHER COIL AND MICROCATHETER. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT ANY DELAY. THERE WAS NO REPORT OF PATIENT INJURY OR COMPLICATION; THE COMPLAINT PRODUCT WAS NEW AND WAS STORED PER LABELING INSTRUCTIONS. THE PROCEDURE WAS CONDUCTED IN ACCORDANCE WITH THE INSTRUCTION FOR

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8308403 ↗
• MalfunctionNov 8, 2018Separation Failure; Device Contamination with Chemical or Other Material; Material Twisted/Bent; Separation Failure; Device Contamination with Chemical or Other Material; Material Twisted/Bent

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, THE 3MM X 6CM CASHMERE 14 (CRC14030630/S12842) THERMO-MECHANICAL COIL FAILED TO DETACH DURING THE PROCEDURE. THE COIL WAS SUCCESSFULLY REMOVED FROM THE PATIENT WITHOUT NEED FOR ADDITIONAL INTERVENTION AND REPLACED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF CONSEQUENCE OR IMPACT TO THE PATIENT. THE SURGERY WAS NOT DELAYED DUE TO THE EVENT. THE PRODUCT WAS PREPPED AND USED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE USER DID NOT CHANGE THE CONNECTING CABLE AND/OR DETACHMENT CONTROL BOX (DCB) DURING THE REPORTED EVENT. THE USER REPORTEDLY ATTEMPTED TO PERFORM THE PRE-DEPLOYMENT ELECTRICAL CHECK BUT DID NOT SUCCEED (PENDING CLARIFICATION). THE EMBOLIC COIL WAS STILL ATTACHED TO THE DELIVERY SYSTEM WHEN REMOVED FROM THE PATIENT AND NO DAMAGE WAS NOTED TO THE EMBOLIC COIL. A 6F ENVOY (67025800/3003521) GUIDING CATHETER, PROWLER-14 DUAL MARKER (606151X/30016814) INFUSION CATHETER, NEUROSCOUT 14 (601314/HN3960) STEERABLE GUIDEWIRE, AND A NEUROSCOUT 14 (601314/HU5767) STEERABLE GUIDEWIRE WERE ALSO USED IN THE CASE. THE COMPLAINT PRODUCT WILL BE RETURNED FOR EVALUATION. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8053551 ↗
• MalfunctionJun 5, 2018Positioning Failure; Positioning Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE COIL EMBOLIZATION PROCEDURE, THE CASHMERE 14 CERECYTE 3 MM X 6.0 CM (CRC14030630 / C29559) COULD NOT BE DETACHED. THE COIL WAS REMOVED AND A NEW COIL WAS USED. THERE WAS NO REPORT OF ANY PATIENT INJURY OR IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7569957 ↗
• MalfunctionSep 7, 2017Positioning Failure; Material Separation; Stretched; Physical Resistance; Positioning Failure; Material Separation; Stretched; Physical Resistance

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING THE PROCEDURE, THE CASHMERE 14 (CRC14030630/ C30942) COULD NOT BE ADVANCED VIA THE UNSPECIFIED MICROCATHETER. THEY WITHDRAW THE COIL AND FOUND IT WAS STRETCHED. THEY USED ANOTHER COIL TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6849440 ↗
• MalfunctionMar 23, 2017Premature Activation; Premature Activation

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING THE PROCEDURE A CASHMERE 3MM X 6.0 CM COIL FAILED TO DETACH DURING SEVERAL ATTEMPTS AND THEN DETACHED WHEN THE COIL WAS WITHDRAWN INTO THE CATHETER. THE PROCEDURE WAS FOR TREATMENT OF A RECURRING POSTERIOR COMMUNICATING ARTERY ANEURYSM THAT WAS TREATED THREE TIMES PRIOR TO THIS PROCEDURE. SIX COILS WERE PLACED IN THE ANEURYSM PRIOR TO THE USE OF THE COMPLAINT CASHMERE COIL. WHEN ATTEMPTING TO DETACH THE CASHMERE 3X6; APPROXIMATELY 10 DETACH CYCLES WERE EMPLOYED IN AN EFFORT TO DETACH THE COIL WITHOUT SUCCESS. THE PRE-DEPLOYMENT ELECTRICAL CHECK WAS PERFORMED AND THE GREEN SYSTEM READY LIGHT 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. THE COIL WAS THEN WITHDRAWN INTO THE MICROCATHETER, WHEN THE COIL WAS PARTIALLY IN THE ANEURYSM AND PARTIALLY IN THE MICROCATHETER ABOUT 1CM INTO THE MICROCATHETER THE COIL DETACHED. THE PHYSICIAN WAS THEN ABLE TO USE THE DPU TO PUSH THE DETACHED COIL BACK INTO THE ANEURYSM WITHOUT INCIDENT. FOUR SUBSEQUENT COILS WERE THEN INTRODUCED AND DETACHED IN THE ANEURYSM W

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6427999 ↗

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