MICRUSPHERE SSR100305-20Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00878528009771), received between Apr 5, 2018 and Nov 26, 2019 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Positioning Failure” (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. 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryNov 26, 2019Separation Failure; Positioning Problem; Premature Separation; Separation Failure; Positioning Problem; Premature Separation

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING AN ANEURYSM COIL EMBOLIZATION PROCEDURE, A 3MM X 5CM MICRUSPHERE XL (SSR10030520/L10588) COIL FAILED TO DETACH. THE POINTS OF THE MARKERS WERE OBSERVED TO BE CORRECT AND A CHANGE WAS MADE IN THE ¿CABLE RELEASE¿ BUT THIS WAS NOT SUCCESSFUL. ¿THE PATIENT¿S COILS ARE REMOVED¿. IT WAS FURTHER STATED THAT ¿THE COILS WERE RELEASED AT THE TIME OF RECAPTURE, OUTSIDE THE ANEURYSM¿ AND THE ¿DEVICE HAD TO BE USED TO TRAP THE COILS RELEASED OUTSIDE THE ANEURYSM¿. NO PATIENT COMPLICATIONS OCCURRED AS A RESULT OF THE EVENT; HOWEVER, THE SURGERY WAS PROLONGED BY 30 MINUTES. IT WAS REPORTED THAT THE PROCEDURE WAS SUCCESSFULLY COMPLETED. A PROWLER 10 MICROCATHETER WAS USED TO DELIVER THE COMPLAINT COIL. THE DEVICE IS NOT AVAILABLE FOR ANALYSIS. NO FURTHER INFORMATION WAS PROVIDED AT THE TIME OF COMPLAINT INITIATION. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE COIL DID NOT COME OFF OF THE DELIVERY WIRE ON ATTEMPT TO DETACH. THE CONTROL CABLE WAS REPLACED AND THE DETACHMENT CONTROL BOX (DCB) WAS CHECKED, BUT THE COIL FAILED TO DETACH. IT WAS STATED THAT ¿AT THE TIME OF RECAPTURING THE COILS AGAIN IT IS RELEASED ALONE, IN THE PATIENT¿. IT WAS FUR

  Patient problems: No Code Available

  MAUDE report 9375891 ↗
• MalfunctionApr 5, 2018Positioning Failure; Positioning Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN EMBOLIZATION PROCEDURE ON (B)(6) 2018, THE MICRUSPHERE XL 3MM X 5CM COIL (SSR10030520 / L10802) FAILED TO DETACH DUE TO THE TWO ENPOWER CONTROL CABLES (ECB00018200) NOT WORKING PROPERLY. THERE WAS NO REPORT OF ANY PATIENT INJURY OR ADVERSE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7401059 ↗