CASHMERE SRC140406-20Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00878528004141), received between Feb 21, 2017 and Mar 23, 2023 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Stretched” (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 16, 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.

• MalfunctionMar 23, 2023Separation Failure; Separation Failure

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, A CASH 14 PLAT COIL 4MMX6CM COIL (SRC14040620, L15473) WOULD NOT DETACH DUE TO NO GREEN LIGHT ON THE DETACHMENT BOX. THE COIL WAS NOT CHECKED PRIOR TO THE USE OF THE COIL. THE COIL WAS REMOVED FROM THE ANEURYSM AND THE SAME MICROCATHETER, CONTROL CABLE AND BOX WERE USED IN THIS CASE. THIS WAS NOT THE FIRST COIL USED IN THE CASE AND THE OTHER COILS USED DETACHED WITHOUT ANY ISSUES. NO SIGNIFICANT DELAY IN TREATMENT. NO NEGATIVE IMPACT ON PATIENT CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16599257 ↗
• MalfunctionFeb 21, 2023Stretched; Premature Separation; Stretched; Premature Separation

  AS REPORTED BY THE FIELD, A CASH 14 PLAT COIL 4MMX6CM (SRC14040620, L15473) WAS ADVANCED THROUGH A HEADWAY DUO 156CM MICROCATHETER. THE COIL BECAME STRETCHED TO THE POINT THAT THE COIL WAS NOT PRESENT WHEN THE DELIVERY SYSTEM OF THE COIL WAS REMOVED FROM THE BODY. THE COIL WAS NOT LEFT INSIDE BODY. IT IS PRESUMED THAT IT IS STILL IN THE MICROCATHETER. THE HEADWAY WAS TAKEN OUT AND REPLACED WITH A DIFFERENT HEADWAY DUO. THE CASE WAS COMPLETED WITHOUT ISSUE WITH NEW MICROCATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16408078 ↗
• InjuryMay 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY THE STERLING STUDY, A (B)(6) FEMALE ((B)(6)) WITH A MEDICAL HISTORY OF CONTROLLED HYPERTENSION AND BEING A CURRENT SMOKER UNDERWENT COIL EMBOLIZATION OF A RIGHT UNRUPTURED SACCULAR ANEURYSM LOCATED IN THE ANTERIOR CIRCULATION, MIDDLE CEREBRAL ARTERY BIFURCATION ON (B)(6) 2020. MODIFIED RANKIN SCALE (MRS) SCORE WAS 0. PER IMMEDIATE PRE-PROCEDURE DIGITAL SUBTRACTION ANGIOGRAPHY PERFORMED ON (B)(6) 2020, THE ANEURYSM HAD THE FOLLOWING DIMENSIONS: HEIGHT 3.9MM, DOME 2.7MM, MAXIMUM ANEURYSM DIAMETER 5MM, NECK SIZE 2.2MM, AND DOME-TO-NECK RATIO 1.2MM. THE PARENT VESSEL DIAMETER WAS 3MM. THE FOLLOWING COILS WERE IMPLANTED VIA AN SL-10 (STRYKER) MICROCATHETER: ONE 4MM X 6MM CASHMERE 14 (MICRUS), ONE 3MM X 6MM GALAXY G3 MINI (GLM930060/K10497), ONE 2MM X 3CM GALAXY G3 MINI (GLM920030/30386750) AND ONE 2MM X 3CM GALAXY G3 MINI (GLM920030/L11009). THE PATIENT DID NOT EXPERIENCE ANY INTRA-OPERATIVE THROMBOEMBOLIC EVENTS. PACKING DENSITY WITHOUT G3 MINI COILS (USING ANGIOSUITE) WAS 20% AND AT THE CONCLUSION OF THE PROCEDURE (USING ANGIOSUITE) WAS 22%. IN THE OPINION OF THE INVESTIGATOR, THE TREATMENT OF THE TARGET ANEURYSM WAS CONSIDERED COMPLETE WITH NO DEVICE-RELATED SERIOUS AD

  Patient problems: Aneurysm

  MAUDE report 14427748 ↗
• MalfunctionFeb 21, 2017Stretched; Stretched

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL THAT THE CASHMERE COIL (SRC14040620/C24289) STRETCHED DURING USE. THERE WERE NO POTENTIAL ADVERSE EVENTS. THE PROCEDURE WAS COMPLETED WITH A SAME/LIKE PRODUCT, AND THERE WAS NO PROCEDURAL DELAY. IT WAS REPORTED THAT THE DEVICE WOULD BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6345521 ↗