CASHMERE CERECYTE CRC140820-30Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00878528004646), received between Oct 12, 2016 and Jul 23, 2018 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Positioning Failure” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• 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 THE COIL WAS WITHDRAWN AND ANOTHER COIL WAS USED TO COMPLETE THE PROCEDURE.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 ↗
• MalfunctionOct 13, 2017Positioning Failure; Positioning Failure

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING THE PROCEDURE, THE CASHMERE COIL (CRC14082030/C27073) COULD NOT BE DETACHED. THEY USED ANOTHER ONE TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF PATIENT INJURY. IT WAS REPORTED THAT THE DEVICE WOULD BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6947128 ↗
• MalfunctionOct 12, 2016Stretched; Stretched

  AS REPORTED BY A HEALTH CARE PROFESSIONAL, DURING A COIL EMBOLIZATION PROCEDURE A CASHMERE 14 CERE 8 MM X 20 CM (CRC14082030/C24696) STRETCHED. THE ENTIRE COIL WAS WITHDRAWN FROM THE MICROCATHETER AND NEW COIL WAS USED TO COMPLETE THE PROCEDURE; THE MICROCATHETER WAS NOT REMOVED. THERE WERE NO KINKS NOTED ON THE MICROCATHETER AND THERE WAS NO RESISTANCE BETWEEN THE MICROCATHETER AND GUIDEWIRE WHEN ACCESSING THE TARGET SITE. AN ADEQUATE CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE MICROCATHETER AT ALL TIMES. THERE WAS NO REPORT ON PATIENT INJURY AND NO REPORTS ON INTRA OR POST-PROCEDURAL COMPLICATIONS. PATIENT INFORMATION IS UNKNOWN. IT WAS INITIALLY REPORTED THAT THE COMPLAINT DEVICE IS AVAILABLE FOR RETURN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6021785 ↗