CASHMERE SRC140512-20Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00878528004004), received between Jun 8, 2017 and Nov 29, 2022 — classified as 2 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. How this data works · Data updated Oct 13, 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.

• MalfunctionNov 29, 2022Separation Failure; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE WITH THE BASILAR ARTERY AS THE PARENT VESSEL, THERE WERE ISSUES DETACHING TWO (2) SEPARATE COILS, A 6MM X 20CM MICRUSPHERE XL 10 (SSR10062020 / 30397660) AND A 5MM X 12CM CASHMERE 14 (SRC14051220 / 30422249) WITH THE ENPOWER CONTROL CABLE (ECB00018200 / 30798739). IT WAS REPORTED THAT THE COIL WAS PARTIALLY DETACHED DURING THE INITIAL CYCLE OF THE ENPOWER CABLE AND BOX. WHEN THE PHYSICIAN PULLED BACK ON THE DELIVERY WIRE, A PORTION OF THE COIL WAS PULLED BACK INTO THE PARENT VESSEL. BOTH TIMES, THE PORTION OF THE COIL WAS PUSHED BACK INTO THE ANEURYSM AND ANOTHER DETACHMENT CYCLE OF THE CABLE WAS PERFORMED SUCCESSFULLY. AFTER THE SECOND OCCURRENCE WITH THE DETACHMENT ISSUE, THE ENPOWER CABLE WAS REPLACED WITH A NEW ONE AND THE REST OF THE COILS USED WAS UNEVENTFUL. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15875593 ↗
• MalfunctionJun 8, 2017Positioning Failure; Positioning Failure

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A NEURO EMBOLIZATION PROCEDURE AN ENPOWER DETACHMENT CONTROL BOX (DCB00000500/F79655) WAS NOT FUNCTIONING. THE PHYSICIAN USED TWO DIFFERENT ENPOWER CABLES (UNKNOWN LOT) TO DEPLOY AN CASHMERE14 5MM X 12CM COIL (SRC14051220/P11597) HOWEVER NONE OF THEM WORKED, SO IT WAS CONCLUDED THAT THE ENPOWER BOX WAS THE PROBLEM. A PRE-DEPLOYMENT ELECTRICAL CHECK WAS PERFORMED AND THE GREEN SYSTEM READY LIGHT ILLUMINATED. DURING THE DETACHMENT CYCLE THE LIGHT DID NOT ILLUMINATE AND THE AUDIBLE SIGNAL DID NOT BEEP. REPORTEDLY, ALL CONNECTIONS APPEARED TO FIT PROPERLY. THE PHYSICIAN DECIDED TO RETRACT THE COIL. THERE WERE NO DAMAGES ON THE CASHMERE COIL THAT WAS BEING DETACHED. THERE WERE NO ADVERSE EVENTS REPORTED AND THERE WERE NO DELAYS IN THE PROCEDURE. IT WAS INITIALLY REPORTED THAT THE COMPLAINT DEVICE IS NOT AVAILABLE FOR RETURN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6621364 ↗