CASHMERE CERECYTE CRC140445-30Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00878528004455), received between Feb 22, 2019 and Feb 22, 2019 — classified as 1 injury.

The most frequently reported specific device problem is “Premature Separation” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• 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 ↗

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