CASHMERE CERECYTE CRC140406-30Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00878528004462), received between Dec 15, 2016 and Aug 18, 2020 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Positioning Failure” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• MalfunctionDec 15, 2016Positioning Failure; Positioning Failure

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING ABDOMINAL VISCERA ANEURYSM AT THE RENAL ARTERY, A CASHMERE COIL (CRC14040630/C36048) COULD NOT BE DETACHED. THE CASHMERE WAS USED FOR THE FIRST COIL DURING THE PROCEDURE; HOWEVER, IT COULD NOT BE DEPLOYED WHEN HANDLING IT FOR DEPLOYMENT. THEREFORE, THE COIL WAS REPLACED WITH ANOTHER COIL (SAME SIZE). THE COIL ALSO COULD NOT BE DEPLOYED, THEREFORE THE CONTROL BOX (CATALOG/LOT UNKNOWN) WAS REPLACED WITH ANOTHER ONE AND THE COIL COULD BE DEPLOYED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT FURTHER ISSUES OR DELAYED. THERE WAS ALSO NO PATIENT INJURY / COMPLICATION REPORTED. THE COMPLAINT PRODUCT WAS NEW AND STORED PER LABELING INSTRUCTIONS. THE PROCEDURE WAS CONDUCTED IN ACCORDANCE WITH THE IFU AND THE CONSTANT FLUSH HAD BEEN MAINTAINED AT ALL TIME. NO VISIBLE DEFECT/DAMAGE WAS NOTED ON THE PRODUCTS PRIOR TO OR AFTER THE EVENT. NO UNINTENDED DETACHMENT WAS OBSERVED IN THE VESSEL OR IN THE MICROCATHETER. THE PRODUCT WAS NOT AVAILABLE AS IT HAD BEEN DISCARDED BY THE CUSTOMER. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6177207 ↗

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