CASHMERE CERECYTERecalls & reported problems across all models

We found 11 models of CASHMERE CERECYTE by Medos International Sàrl in the FDA's device registry (GUDID). Together they are named in 35 adverse event reports in the FDA's MAUDE database, received between Sep 27, 2016 and Nov 9, 2021 — classified as 2 injuries, 33 malfunctions.

The most frequently reported specific device problem is “Positioning Failure” (11 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported CASHMERE CERECYTE problems

CASHMERE CERECYTE models

11 models, most reported first. Each model has its own page with its reports, recalls and device details.

• CASHMERE CERECYTE CRC140306-30

  DEVICE, NEUROVASCULAR EMBOLIZATION
  6 reports
• CASHMERE CERECYTE CRC140225-30

  DEVICE, NEUROVASCULAR EMBOLIZATION
  5 reports
• CASHMERE CERECYTE CRC140408-30

  DEVICE, NEUROVASCULAR EMBOLIZATION
  5 reports
• CASHMERE CERECYTE CRC140304-30

  DEVICE, NEUROVASCULAR EMBOLIZATION
  4 reports
• CASHMERE CERECYTE CRC140615-30

  DEVICE, NEUROVASCULAR EMBOLIZATION
  4 reports
• CASHMERE CERECYTE CRC140512-30

  DEVICE, NEUROVASCULAR EMBOLIZATION
  3 reports
• CASHMERE CERECYTE CRC140820-30

  DEVICE, NEUROVASCULAR EMBOLIZATION
  3 reports
• CASHMERE CERECYTE CRC140406-30

  DEVICE, NEUROVASCULAR EMBOLIZATION
  2 reports
• CASHMERE CERECYTE CRC140303-30

  DEVICE, NEUROVASCULAR EMBOLIZATION
  1 report
• CASHMERE CERECYTE CRC140445-30

  DEVICE, NEUROVASCULAR EMBOLIZATION
  1 report
• CASHMERE CERECYTE CRC141025-30

  DEVICE, NEUROVASCULAR EMBOLIZATION
  1 report

Recent CASHMERE CERECYTE adverse event reports

The 15 most recent reports across all models, 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 ↗
• 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 ↗
• MalfunctionAug 18, 2020Separation Failure; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE ANEURYSM EMBOLIZATION PROCEDURE, THE ENPOWER DETACHMENT CONTROL (DCB) (DCB00000500 / D10006) COULD NOT DETACH THE COIL. THE PHYSICIAN REPORTED THAT THE ERROR LIGHT CAME ON THE FIRST TIME THE COIL (UNKNOWN CATALOG / LOT) SYSTEM WAS CONNECTED TO THE DCB. HE ATTEMPTED A SECOND TIME TO CONNECT AND THE GREEN LIGHT CAME UP. THE PHYSICIAN THEN CONTINUED TO IMPLANT THE COIL, BUT IT COULD NOT BE DETACHED. THE PHYSICIAN WITHDREW THE COIL FROM THE PATIENT¿S BODY AND REPLACED IT WITH A NEW COIL AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORT OF OF ANY PATIENT ADVERSE EVENT OR COMPLICATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10420986 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• InjuryFeb 22, 2019Separation Failure; Premature Separation; Separation Failure; Premature Separation

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE PROCEDURE TO TREAT A 4 MM ANEURYSM ON THE ANTERIOR COMMUNICATING ARTERY (ACOM), THE 4 MM X 4.5 CM CASHMERE 14 CERECYTE COIL (CRC14044530 / C26712) PASSED THE FAULT LIGHT TEST, WAS FLUSHED AND DELIVERED THROUGH THE SL-10® MICROCATHETER (STRYKER) AND DEPLOYED AT THE TARGET ANEURYSM BUT FAILED TO DETACH AFTER THE FIRST DETACH CYCLE. THERE WERE TWO MORE DETACHMENT CYCLES PERFORMED WITHOUT SUCCESS. THE PHYSICIAN THEN SLIGHTLY MANIPULATED THE COIL AND CYCLE THROUGH ANOTHER DETACHMENT CYCLE WITHOUT SUCCESS. THIS TECHNIQUE OF SLIGHTLY MANIPULATING THE COIL WAS EMPLOYED TWO MORE TIMES WITHOUT SUCCESS. IN ALL, THERE WERE A TOTAL OF 6 DETACHMENT CYCLES ATTEMPTED WITH THE COIL FAILING TO DETACH. THE PHYSICIAN THEN ATTEMPTED TO REMOVE THE COIL FROM THE ANEURYSM. UPON RETRACING THE COIL 1 CM BACK INTO THE MICROCATHETER, THE COIL DETACHED FROM THE PUSHER WIRE. THE PHYSICIAN THEN USED THE PUSHER WIRE TO PUSH THE COIL BACK INTO THE ANEURYSM WITH SUCCESS. A 2.5 CM X 4 MM TARGET® NANO¿ COIL (STRYKER) WAS THEN DEPLOYED AND DETACHED INTO THE ANEURYSM WITHOUT INCIDENT. AT THIS POINT, THE CASE WAS CONCLUDED. THERE WAS NO REPORT OF PATIENT COMPLICATIONS

  Patient problems: No Code Available

  MAUDE report 8362195 ↗
• 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 ↗
• 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 ↗
• MalfunctionDec 18, 2018Separation Failure; Separation Failure

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A COIL EMBOLIZATION OF AN INTRACRANIAL ANEURYSM, THE 6MM X 15CM CASHMERE 14 (CRC14061530/C41134) THERMO-MECHANICAL COIL WAS DELIVERED TO THE TARGET LESION, BUT THE EMBOLIC COIL FAILED TO DETACH. THE COIL WAS REMOVED AND REPLACED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT FURTHER INCIDENT OR DELAY. NO PATIENT COMPLICATIONS OCCURRED AS A RESULT OF THE EVENT. THE PRODUCT WAS NEW AND STORED AND HANDLED ACCORDING TO THE LABELING INSTRUCTIONS. THE PROCEDURE WAS CONDUCTED IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFU) AND A CONSTANT FLUSH WAS MAINTAINED. THE DEVICE WAS PACKAGED SECURELY AS EXPECTED. THERE WAS NO DAMAGE NOTED TO THE CATHETER PACKAGING OR SHIPPING CONTAINER. THE PRODUCT WILL BE RETURNED FOR EVALUATION. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8174483 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• MalfunctionJul 23, 2018Separation Failure; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE PROCEDURE, THE CASHMERE 14 CERECYTE COIL 8 MM X 20 CM (CRC14082030/ C27073) 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 7712771 ↗

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