MICRUSPHERE SSR181028-20Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00878528009900), received between Oct 8, 2018 and Oct 1, 2022 — classified as 1 injury, 2 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 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.

• InjuryOct 1, 2022Entrapment of Device; Migration; Premature Separation; Entrapment of Device; Migration; Premature Separation

  THE HEALTHCARE PROFESSIONAL REPORTED DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE TARGETING A BASILAR FUSIFORM ANEURYSM, THE ANEURYSM WAS TREATED WITH A FRED¿ FLOW DIVERTER STENT (MICROVENTION) AND A ¿JAILED¿ MICROCATHETER INSIDE THE BODY OF THE FUSIFORM, PER THE PHYSICIAN, PART OF THE 10MM X 28CM MICRUSPHERE XL (SSR18102820 / L14675) BECAME SNAGGED WITH A TINE OF THE FLOW DIVERTER; THIS CAUSED THE COIL TO DETACH FROM THE DELIVERY WIRE OF THE COIL. ABOUT HALF OF THE COIL REMAINED IN THE PARENT VESSEL. MULTIPLE UNSUCCESSFUL ATTEMPTS WERE MADE TO CAPTURE THE COIL WITH STENT RETRIEVERS AND SNARES. ULTIMATELY, THE PHYSICIAN DECIDED TO USE ENTERPRISE STENTS TO TACK THE COIL OUTSIDE OF THE ANEURYSM TO THE WALL OF THE BASILAR ARTERY. IT WAS REPORTED THAT THE PATIENT STAYED INTUBATED POST-PROCEDURE. THE DURATION OF THE INTUBATION POST-PROCEDURE WAS NOT REPORTED. THE PATIENT TREATMENT WAS DELAYED DUE TO THE TIME TAKEN TO ATTEMPT TO EXTRACT THE COIL, HOWEVER, THE DURATION OF THE DELAY WAS NOT REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 15526053 ↗
• MalfunctionJan 16, 2019Stretched; Positioning Problem; Stretched; Positioning Problem

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A COIL EMBOLIZATION OF A SUBARACHNOID HEMORRHAGE DUE A RUPTURED INTRACRANIAL ANEURYSM, THE USER HAD DIFFICULTY POSITIONING THE 10MM X 28CM MICRUSPHERE XL (SSR18102820/S11055) THERMO-MECHANICAL COIL IN THE TARGET SITE AS THE COIL DID NOT CONFORM TO THE WALLS OF THE ANEURYSM AND THE SHAPE OF THE COIL DID NOT APPEAR AS EXPECTED. THE COIL WAS PARTIALLY DEPLOYED AND PARTIALLY IN THE ECHELON-10 (MEDTRONIC) MICROCATHETER. THE MICROCATHETER LOST ITS POSITION AS A RESULT OF THE EVENT. THE USER REMOVED THE COIL, BUT THE COIL FAILED TO RESHEATH. THE COIL WAS REPLACED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE SAME MICROCATHETER WAS USED TO COMPLETE THE CASE. THERE WAS NO REPORT OF CONSEQUENCE OR IMPACT TO THE PATIENT. THE SURGERY WAS DELAYED FIVE MINUTES DUE TO THE EVENT. THE DEVICE WAS STORED AND HANDLED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). AN ADEQUATE AND CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE MICROCATHETER. THE DEVICE WAS PREPPED WITHOUT ANY DIFFICULTY. THE INTRODUCER DID NOT APPEAR DAMAGED. THERE WAS NO DIFFICULTY ENCOUNTERED UNSHEATHING THE INTRODUCER TUBE FROM THE DELIVERY TUBE OF THE DEVICE AND THE COIL/DEVICE POSITI

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8253406 ↗
• MalfunctionOct 8, 2018Stretched; Stretched

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A COIL EMBOLIZATION OF AN ANEURYSM, THE SHEATH RIPPED WHEN THE 10MM X 28CM MICRUSPHERE XL (SSR18102820/L10422) THERMO-MECHANICAL COIL WAS MOVED INTO THE UNSPECIFIED MICROCATHETER. NO PATIENT COMPLICATIONS OCCURRED AS A RESULT OF THE EVENT. THERE WAS NO PROCEDURAL DELAY. MULTIPLE ATTEMPTS WERE MADE WITHOUT SUCCESS TO OBTAIN ADDITIONAL INFORMATION. EVALUATION OF THE RETURNED PRODUCT REVEALED STRETCHING OF THE EMBOLIC COIL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7945509 ↗