MICRUSPHERE SSR100410-20Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00878528009948), received between Nov 30, 2016 and Feb 10, 2020 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Positioning Failure” (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.

• MalfunctionFeb 10, 2020Stretched; Stretched

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A COIL EMBOLIZATION, WHEN USING A 4MMX10CM MICRUSPHERE XL (SSR10041020, LOT UNKNOWN) AS A LAST COIL, THE DOCTOR PLACED THE DISTAL PORTION OF THE COIL INTO THE MICROCATHETER HUB, INTACT WITH WHITE SHEATH AND THEN TRY TO ADVANCE THE COIL BY STRIPPING THE PLASTIC END OF THE COIL FROM THE PROXIMAL END. THEN THE DARK GREEN SLIDER IN THE PROXIMAL END OF THE COIL WAS MOVED TO THE LEFT SIDE TOWARDS DISTAL PORTION OF THE COIL AND WHILE THE WHITE STRING OF PLASTIC WAS PEELED AT THE OPPOSITE END. DURING THIS PROCESS, PEELING OFF THE WHITE STRIP WAS NOT DONE PROPERLY DUE TO THE FACT THAT THE COIL COULDN'T ADVANCE THROUGH THE MICROCATHETER. AFTER SEVERAL ATTEMPTS TO RECTIFY THE PROCESS, THE COIL WAS NOT APT FOR THE FURTHER PROCEDURE, THIS LEAD TO PLASTIC BEING ENTANGLED IN THE DARK GREEN SLIDER. ANOTHER COIL WAS USED TO FINISH THE PROCEDURE. THERE WAS NO PATIENT INJURY REPORTED. THE COIL WAS INITIALLY REMOVED FROM THE DISPENSER HOOP AND THERE WERE NO INTERNAL ISSUES FROM THE COIL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9686521 ↗
• MalfunctionAug 4, 2017Positioning Failure; Positioning Failure

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL THAT A 4X10 MICRUSPHERE XL (SSR10041020/C29772) WAS USED DURING A PROCEDURE AND THE COIL COULD NOT BE DETACHED. THE 4X10 MICRUSPHERE XL (COMPLAINT PRODUCT) WAS DELIVERED TO THE ANEURYSM AS THE FIRST FRAMING COIL. AFTER SIGNIFICANT DIFFICULTY GETTING THE COIL TO SEAT PROPERLY IN THE ANEURYSM, DUE TO THE SHAPE OF THE ANEURYSM, THE COIL WOULD NOT DETACH. AFTER MULTIPLE ATTEMPTS AT PUSHING DETACHMENT BUTTON, REPOSITIONING THE COIL, SLIGHTLY ADJUSTING THE MICROCATHETER TIP, OPENING A 2ND ENPOWER CONTROL CABLE, OPENING A 2ND CONTROL BOX THE COIL WOULD STILL NOT DETACH. THERE IS NO REPORT OF PATIENT INJURY. THE PRODUCT WAS DISCARDED AND THEREFORE WILL NOT BE RETURNED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6768309 ↗
• MalfunctionNov 30, 2016Positioning Failure; Positioning Failure

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, AN ORBIT GALAXY G2 (641CF0412/ P11424) FAILED PRE-PROCEDURE ELECTRICAL TESTING, AND A MICRUSPHERE XL (641CF0412/ P11424) COULD NOT BE DETACHED. THE PROCEDURE WAS COIL EMBOLIZATION OF AN INTERNAL CAROTID ARTERY SUPRACLINOID ANEURYSM. AFTER OPENING THE ORBIT GALAXY G2, THE PHYSICIAN ATTACHED THE CONNECTING CABLE WITH THE COIL HUB FOR PRE-DEPLOYMENT CHECK, AND THERE WAS NO LIGHT IN THE DETACHMENT BOX. THEN A MICRUSPHERE XL COIL WAS DEPLOYED AT THE LOCATION OF THE ANEURYSM, AND IT COULD NOT BE DETACHED AND WAS REMOVED FROM THE PATIENT. A PRE-DEPLOYMENT ELECTRICAL CHECK HAD BEEN PERFORMED. THERE HAD BEEN NO RESISTANCE BETWEEN THE COIL AND ECHELON 10 MICROCATHETER. LOW BATTERY LIGHT AND FAULT LIGHT WAS NOT SEEN DURING THE CASE. UPON PRESSING THE POWER BUTTON, ALL LIGHTS ILLUMINATED AND DURING THE DETACHMENT CYCLE, THE DETACHMENT LIGHT ILLUMINATED AND THE AUDIBLE SIGNAL BEEPED. THE SAME DCB (LOT F75996) AND CONNECTING CABLE (LOT P11658) WERE USED SUCCESSFULLY WITH THESE COILS AND SUBSEQUENT COILS. ALL CONNECTIONS FIT PROPERLY WITHOUT NEED FOR FORCE. IT WAS REPORTED THAT ONLY THE GALAXY G2 WAS AVAILABLE TO BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6134689 ↗