CASHMERE SRC140615-20Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00878528004011), received between Jan 25, 2018 and Jan 25, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Kinked” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 25, 2018Kinked; Kinked

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING COIL EMBOLIZATION OF A RUPTURED OPHTHALMIC ARTERY ANEURYSM, A CASHMERE COIL (SRC14061520 / P11734) COULD NOT BE ADVANCED THROUGH THE EXCELSIOR SL-10 MICROCATHETER AND STRETCHED WHEN IT WAS PULLED BACK. BOTH THE COIL AND MICROCATHETER WERE REMOVED FROM THE PATIENT. A CONTINUOUS FLUSH HAD BEEN MAINTAINED THROUGH THE MICROCATHETER. THE COIL DID NOT DETACH OR SEPARATE IN THE MICROCATHETER. ANOTHER CASHMERE (SRC14061520 / P10614) COULD NOT BE RE-SHEATHED BECAUSE THE PEEL-AWAY PART OF THE INTRODUCER SHEATH WAS DAMAGED AND THE COIL WAS FOUND TO BE KINKED DURING PRODUCT ANALYSIS. THERE HAD BEEN NO DIFFICULTY DURING UNSHEATHING THE DEVICE. BOTH DEVICES HAD BEEN PREPPED AND USED AS PER THE INSTRUCTIONS FOR USE (IFU). THERE WERE NO PATIENT CONSEQUENCES DUE THE EVENTS. NO FURTHER DETAILS WERE AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7218048 ↗