MICRUSPHERE SSR100825-20Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00878528009962), received between Jul 19, 2017 and Aug 20, 2019 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Stretched” (3 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 20, 2019Stretched; Positioning Problem; Stretched; Positioning Problem

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A COIL EMBOLIZATION TO THE MIDDLE CEREBRAL ARTERY (MCA), THERE WAS DIFFICULTY POSITIONING THE 8MMX25CM MICRUSPHERE XL COIL (SSR10082520, S13904) IN THE TARGET SITE, THE COIL DID NOT CONFORM TO THE WALLS OF THE ANEURYSM. THEN, THE USER WAS NOT ABLE TO RESHEATH THE COIL. IT BECAME ¿STUCK¿ WHILE RESHEATHING, IT WAS NOT GOING IN. THE EVENT WAS NOT CAUSED BY RESISTANCE BETWEEN THE COIL AND INTRODUCER. THERE WERE NO SURGERY DELAYS DUE TO THE REPORTED EVENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER COIL. THERE WAS NO PATIENT INJURY REPORTED. THE COIL DELIVERY SYSTEM WAS PREPPED WITHOUT ANY DIFFICULTY. THE DEVICE WAS STORED AND HANDLED PER INSTRUCTIONS FOR USE (IFU). THERE WAS NO FIT ISSUE DUE TO SELECTING AN INAPPROPRIATE SIZE OF COIL. IT WAS NOTED THE 16MM X 12MM ANEURYSM WAS ¿GIANT¿ AND HAVING AN ¿IRREGULAR SHAPE¿. THERE WAS NO DIFFICULTY ENCOUNTERED UNSHEATHING (STRIPPING AWAY). AN ADEQUATE AND CONTINUOUS FLUSH WAS MAINTAINED. THE INTRODUCER WAS NOT DAMAGED IN ANY WAY. THE COIL INTRODUCER WAS INSERTED THROUGH THE RHV AND SEATED INTO THE HUB OF THE INFUSION CATHETER. THE CLEAR TAB OF THE INTRODUCER SHEATH HAD BEEN PULLED OUT

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8910881 ↗
• MalfunctionJul 31, 2018Material Twisted/Bent; Material Twisted/Bent

  THE HEALTHCARE PROFESSIONAL REPORTED THAT THE MICRUSPHERE XL 10 STRETCH RESISTANT COIL 8 MM X 25 CM (SSR10082520 / C19812) COULD NOT BE ADVANCED IN THE INTRODUCER. ADDITIONAL INFORMATION RELATED TO THE TARGET VESSEL WAS NOT AVAILABLE. THE COIL WAS NOT USED AS IT DID NOT SLIDE CORRECTLY THROUGH THE INTRODUCER. THERE WAS NO REPORT OF PATIENT INJURY OR ADVERSE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7735460 ↗
• MalfunctionJun 18, 2018Kinked; Kinked

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A COIL EMBOLIZATION OF A BASILAR ANEURYSM, TWO 8MM X 25CM MICRUSPHERE XL COILS (SSR10082520/P10735) AND (SSR10082520/S10024) COULD NOT BE PUSHED INTO THE UNSPECIFIED MICROCATHETER. THERE WAS NO REPORT OF CONSEQUENCE OR IMPACT TO THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7609528 ↗
• MalfunctionJun 18, 2018Kinked; Stretched; Kinked; Stretched

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A COIL EMBOLIZATION OF A BASILAR ANEURYSM, TWO 8MM X 25CM MICRUSPHERE XL COILS (SSR10082520/(B)(4)) AND (SSR10082520/(B)(4)) COULD NOT BE PUSHED INTO THE UNSPECIFIED MICROCATHETER. THERE WAS NO REPORT OF CONSEQUENCE OR IMPACT TO THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7609525 ↗
• MalfunctionMay 29, 2018Stretched; Stretched

  THE HEALTHCARE PROFESSIONAL REPORTED THAT THE MICRUSPHERE XL 8 MM X 25 CM (SSR10082520 / S13904) ENCOUNTERED RESISTANCE WHEN IT WAS BEING ADVANCED INSIDE THE MICROCATHETER. WHEN THE COIL WAS REMOVED FROM THE MICROCATHETER, IT BECAME STRETCHED. ANOTHER COIL WAS USED FOR THE PROCEDURE. THERE WAS NO REPORT OF ANY PATIENT INJURY OR COMPLICATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7549644 ↗
• MalfunctionJul 19, 2017Positioning Failure; Positioning Failure

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING THE EMBOLIZATION OF A POSTERIOR COMMUNICATING ARTERY ANEURYSM A MICRUSPHERE XL COIL 8 MM X 25 CM (SSR10082520/ P10735) FAILED TO DETACH WHEN USED WITH AN ENPOWER DCB (DCB00000500/F75996) AND CONNECTING CABLE (CCB00015700/P11439). THE PHYSICIAN DEPLOYED THE MICRUSPHERE COIL AFTER THE COIL MARKER CROSSED THE PROXIMAL MARKER FOR THE MICROCATHETER, THE CONNECTING CABLE WAS THEN CONNECTED TO THE DETACHMENT BOX. THE DETACHMENT BOX WHICH WAS INITIALLY SHOWING A GREEN LIGHT WITH FULL BATTERY SUDDENLY SHOWED A RED LIGHT IN THE INDICATOR (4TH LIGHT IN THE DETACHMENT BOX). THE PHYSICIAN ATTEMPTED TO DETACH THE COIL, HOWEVER THE COIL FAILED TO DETACH. THE PHYSICIAN WAITED FOR SOME TIME, THE LIGHT IN THE DETACHMENT BOX WAS GREEN AGAIN, HOWEVER THE COIL DID NOT DETACH. REPORTEDLY, A PRE-DEPLOYMENT ELECTRICAL CHECK WAS PERFORMED AND THE AUDIBLE SIGNAL BEEPED DURING THE DETACHMENT CYCLE. ALL CONNECTIONS WERE REPORTED TO FIT PROPERLY WITHOUT APPLICATION OF EXCESSIVE FORCE. THE ENTIRE SYSTEM WAS REMOVED. THE COIL WAS STILL ATTACHED TO THE COIL DELIVERY SYSTEM WHEN REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED USING COMPETITOR¿S COILS. IT WAS I

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6725337 ↗