MICRUSPHERE SPH100250-20Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00878528003519), received between Apr 1, 2015 and Dec 7, 2018 — classified as 4 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.

• MalfunctionDec 7, 2018Stretched; Stretched

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE COIL EMBOLIZATION PROCEDURE TO TREAT AN INTRACRANIAL ANEURYSM, THE PHYSICIAN USED THE MICROSPHERE 10 PLATINUM 2.5MM X 3.3CM COIL (SPH10025020 / S11747), AND THE COIL STRETCHED. THE PHYSICIAN FOUND THAT THE COIL COULD NOT CHANGE ITS SHAPE TO BE A BASKET-LIKE; IT WAS ALSO NOT CONFORMING WELL TO THE ANEURYSM WALL WHICH INCREASES THE RISK OF SUBSEQUENT ANEURYSM EMBOLIZATION. THE PHYSICIAN DECIDED TO REMOVE THE MICROSPHERE 10 PLATINUM COIL AND REPLACED IT WITH THE CASHMERE 14 CERECYTE 3MM X 4CM COIL ((B)(4)) WHICH SUCCESSFULLY FORMED THE BASKET-LIKE SHAPE THAT THE PREVIOUS COIL COULD NOT ACHIEVE. THE PHYSICIAN USED THE DELTAPAQ 10 CERECYTE 1.5MM X 2CM COIL ((B)(4)) TO FILL IN THE ANEURYSM COMPLETELY AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT ANY PATIENT INJURY OR ADVERSE EVENT. THE COMPLAINT PRODUCT WAS NEW AND WAS STORED AND HANDLED ACCORDING TO THE LABELING INSTRUCTIONS / INSTRUCTIONS FOR USE (IFU). THE DEVICE PACKAGING WAS SECURE. THERE WAS NO DAMAGE TO THE PACKAGING. THE PROCEDURE WAS CONDUCTED IN ACCORDANCE WITH THE INSTRUCTION FOR USE (IFU) WITH CONSTANT FLUSH MAINTAINED AT ALL TIME. IT WAS REPORTED THAT THE PRODUCT IS

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8144661 ↗
• MalfunctionDec 20, 2017Positioning Failure; Positioning Failure

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL THAT A MICRUSPHERE COIL ((B)(4)) WAS USED DURING A PROCEDURE AND THE COIL COULD NOT BE DETACHED. THE COIL WAS WITHDRAWN FROM THE PATIENT AND ANOTHER WAS USED TO COMPLETE THE PROCEDURE. THERE IS NOT REPORT OF PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7133420 ↗
• MalfunctionSep 21, 2017Stretched; Stretched

  THE HEALTHCARE PROFESSIONAL REPORTED THAT THE MICROSPHERE 10 PLATINUM COIL 2.5MM X 3.3CM (SPH10025020 / P11581) BECAME STRETCHED DURING THE COIL EMBOLIZATION PROCEDURE. ANOTHER COIL WAS USED, AND THE PROCEDURE WAS COMPLETED WITHOUT ANY REPORT OF PATIENT INJURY OR ADVERSE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6883725 ↗
• MalfunctionApr 1, 2015Product Quality Problem

  DURING A COIL EMBOLIZATION PROCEDURE (ARTERY INFORMATION UNAVAILABLE), WHEN THE SURGEON OPENED THE PACKAGE OF THE MICROSPHERE COIL (SPH10025020/C19643), HE NOTED THAT ONLY 2 RINGS (LOOPS) INSTEAD OF THE EXPECTED 6 RINGS WAS FOUND. THE SURGEON HAD TO CHANGE TO ANOTHER COIL. IT WAS REPORTED THAT THE COIL DID NOT APPEAR STRETCHED, KINKED OR DAMAGED. THERE HAD BEEN NO DIFFICULTY IN EXPOSING THE COIL TO EXAMINE IT, AND THERE WAS NO PACKAGING DAMAGE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER PRODUCT. THERE WAS NO PATIENT INVOLVEMENT. THE DEVICE WILL BE RETURNED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 4649283 ↗