CASHMERE CERECYTE CRC140615-30Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00878528004561), received between Oct 28, 2016 and Dec 18, 2018 — classified as 4 malfunctions.

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

• 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 ↗
• MalfunctionDec 28, 2016Positioning Failure; Stretched; Positioning Failure; Stretched

  AS REPORTED BY A HEALTH CARE PROFESSIONAL, DURING COIL INTERVENTION A CASHMERE COIL (CRC14061530/C35338) DID NOT DETACH. THE PROCEDURE WAS DUAL MICROCATHETER COILING OF A LEFT SIDE ANTERIOR COMMUNICATING ARTERY ANEURYSM IN A 65 YEAR OLD FEMALE PATIENT. THE ANEURYSM DIMENSIONS WERE NECK 4.6 MM AND DOME 6.6 MM. THE SAME CONNECTING CABLE AND DETACHMENT BOX WAS USED WITH FIVE OTHER COILS AND EXCEPT THE REPORTED COIL THERE WAS NO PROBLEM WITH DETACHMENT. THERE WAS 15 MINUTES OF DELAY DUE TO THE REPORTED EVENT; THE BATTERIES WERE CHANGED, CONNECTING CABLE WAS CHANGED, DETACHMENT HOWEVER THE COIL DID NOT DETACH AFTER 4 ATTEMPTS. THE OTHER CODMAN COIL (LOT UNKNOWN) IN THE SECOND MICROCATHETER WAS DETACHED WITH NO PROBLEM. THE COMPLAINT PRODUCT WAS REMOVED AND REPLACED WITH A SAME LIKE PRODUCT. IT WAS REPORTED THAT A PRE-DEPLOYMENT ELECTRICAL CHECK WAS PERFORMED AND ALL CONNECTIONS APPEARED TO FIT PROPERLY WITHOUT APPLICATION OF EXCESSIVE FORCE. THE DETACHMENT LIGHT DID NOT ILLUMINATE DURING THE DETACHMENT CYCLE. THE COMPLAINT COIL WAS STILL ATTACHED TO THE DELIVERY SYSTEM UPON REMOVAL; HOWEVER WAS FOUND TO BE STRETCHED. THERE WERE NO PATIENT CONSEQUENCES AND PATIENT OUTCOME WAS REPORTED TO

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6210915 ↗
• MalfunctionNov 15, 2016Positioning Failure; Premature Activation; Positioning Failure; Premature Activation

  THE CONTACT FROM THE FACILITY REPORTED THAT DURING COIL EMBOLIZATION AT THE INTERNAL ILIAC ARTERY THE CASHMERE COIL (CRC140615-30/C27116) COULD NOT BE DETACHED. THE PROCEDURE WAS THE COIL EMBOLIZATION AT THE INTERNAL ILIAC ARTERY. THE PATIENT'S VESSELS WERE MODERATELY TORTUROUS AND NOT CALCIFIED. A SHEATH INTRODUCER (MEDIKIT), A GUIDE WIRE (GT 14), A GUIDING CATHETER (4F JR), A MICRO CATHETER (ESTREAM STR, TOKAI MEDICAL), AND AN ENPOWER WERE ALSO USED FOR THIS PROCEDURE. AN APPROACH WAS TAKEN FROM THE LEFT FEMORAL ARTERY WITH THE GUIDING CATHETER AND THE MICRO CATHETER TO THE ORIGIN OF THE RIGHT INTERNAL ILIAC ARTERY. THREE COILS WERE EMBEDDED AS A FILLING IN THE TARGET LESION WITHOUT ANY ISSUE. FOR THE FOURTH COIL, THE CASHMERE (COMPLAINT PRODUCT) WAS DELIVERED TO THE LESION WITH THE SAME DETACHING DEVISE. HOWEVER THE COIL WAS NOT DETACHED AFTER PRESSING THE DETACHMENT BUTTON. AFTER THE PHYSICIAN PRESSED THE DETACHMENT BUTTON FOR FOUR TIMES WITHOUT ANY DETACHMENT, THE COIL WAS RETRACTED FROM THE LESION. THEN THE COIL WAS DETACHED UNINTENTIONALLY AT THE HUB OF A Y CONNECTOR. THE COIL WAS EXPOSED FROM THE Y CONNECTOR, SO IT WAS COMPLETELY REMOVED FROM THE PATIENT. TWO MORE COILS WER

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6104919 ↗
• MalfunctionOct 28, 2016Stretched; Stretched

  AS REPORTED BY A HEALTH CARE PROFESSIONAL, DURING COIL EMBOLIZATION OF A PSEUDOANEURYSM IN THE ABDOMEN CASHMERE 14 CERE 6 MM X 15 CM COIL (CRC14061530/C34305) FAILED TO RE-SHEATH. THE CASHEMERE COIL WAS THE FIRST COIL USED DURING THE PROCEDURE. THE PHYSICIAN TRIED TO RE-SHEATH THE COIL TO CHANGE TO A COIL OF A DIFFERENT SIZE; HOWEVER WAS UNABLE TO RE-SHEATH THE COIL. THE PHYSICIAN FELT THE COIL HAD STRETCHED. THE COMPLAINT COIL WAS REPLACED WITH ANOTHER COIL (DELTAMAXX6X25/ LOT UNKNOWN) AFTER WHICH FOUR COILS (TARGET, STRYKER) WERE USED FOR THE PROCEDURE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT FURTHER ISSUES OR DELAY. THERE WERE NO PATIENT INJURIES OR COMPLICATIONS REPORTED. THE COMPLAINT PRODUCT WAS NEW AND STORED PER LABELING INSTRUCTIONS. THE PROCEDURE WAS CONDUCTED IN ACCORDANCE WITH THE IFU AND A CONSTANT FLUSH WAS MAINTAINED AT ALL TIMES. NO VISIBLE DEFECT OR DAMAGE WAS NOTED ON THE PRODUCTS PRIOR TO. NO UNINTENDED DETACHMENT WAS OBSERVED IN THE VESSEL OR IN THE MICROCATHETER. THE PATIENT INFORMATION WAS UNKNOWN. THE PATIENTVESSEL LEVEL OF TORTUOUSNESS AND CALCIFICATION WERE UNKNOWN. THE COMPLAINT PRODUCT CASHMERE COIL (LOT# C34305) WILL BE RETURNED FOR INVE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6063877 ↗