MICRUSPHERE SPH100300-20Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00878528003526), received between Jan 22, 2018 and Aug 13, 2020 — classified as 3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 13, 2020Separation Failure; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE PROCEDURE WITH THE TARGET LESION ON THE C7 SEGMENT OF THE RIGHT INTERNAL CAROTID ARTERY (ICA), AFTER THE FIRST COIL WAS SUCCESSFULLY IMPLANTED, THE 3MM X 5.4CM MICRUSPHERE 10 PLATINUM COIL (SPH10030020 / L10750) WAS THE SECOND COIL BUT IT FAILED TO DETACH AT THE SAME LOCATION WHEN THE PHYSICIAN USED THE SAME DELIVERY METHOD AS WITH THE FIRST COIL. THE PHYSICIAN CHANGED THE CONNECTING CABLE AND THE DETACHMENT CONTROL BOX (DCB), BUT THE ISSUE STILL PERSISTED; THE DCB SHOWED SYSTEM ERROR. THE PHYSICIAN SUCCESSFULLY REMOVED THE COIL STILL ATTACHED TO THE DELIVERY SYSTEM FROM THE PATIENT AND REPLACED IT TO COMPLETE THE PROCEDURE. THE COIL WAS NOT STRETCHED NOR DAMAGE WHEN IT WAS REMOVED. IT WAS REPORTED THAT AFTER THE COMPLAINT COIL WAS WITHDRAWN FROM THE PATIENT¿S BODY, THE PHYSICIAN ATTEMPTED TO TEST IT FOR THE DETACHMENT ISSUE HE ENCOUNTERED; THE COIL DETACHED SUCCESSFULLY OUTSIDE THE PATIENT¿S BODY. THE ATTEMPT TO DETACH THE COIL WAS MADE WITH THE ENPOWER DETACHMENT CONTROL BOX (DCB) USING THE ENPOWER CONNECTING CABLE. THE SAME DCB WAS USED TO DETACH SUBSEQUENT COIL BUT NOT THE SAME CONNECTING CABLE. A PRE-DEPLOYMENT ELECTRICAL CH

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10404624 ↗
• MalfunctionAug 30, 2018Stretched; Premature Separation; Stretched; Premature Separation

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, THE 3MM X 5.4CM MICRUSPHERE 10 (SPH10030020/S10858) THERMO-MECHANICAL COIL COULD NOT BE ADVANCED THROUGH THE UNSPECIFIED MICROCATHETER. THE COIL WAS REMOVED FROM THE MICROCATHETER AND WAS NOTED TO BE STRETCHED. THE COIL WAS REPLACED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS OCCURRED AS A RESULT OF THE EVENT. THE PRODUCT WILL BE RETURNED FOR EVALUATION. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7833438 ↗
• MalfunctionJan 22, 2018Detachment Of Device Component; Entrapment of Device; Stretched; Material Protrusion/Extrusion; Positioning Problem; Detachment Of Device Component; Entrapment of Device; Stretched; Material Protrusion/Extrusion; Positioning Problem

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING BALLOON-ASSISTED COIL EMBOLIZATION OF A 4MM X 3MM RIGHT MIDDLE CEREBRAL ARTERY (MCA) ANEURYSM, THE 3MM X 5.4CM MICRUSPHERE PLATINUM THERMO-MECHANICAL COIL (SPH10030020/C18449) HERNIATED INTO THE PARENT ARTERY. THE ENTIRE COIL WAS SUCCESSFULLY REMOVED FROM THE PATIENT STILL ATTACHED TO THE DELIVERY SYSTEM. THE COIL WAS NOTED TO BE STRETCHED UPON REMOVAL. FRAGMENTS WERE NOT GENERATED FROM THE BROKEN COIL. IT WAS SUSPECTED THAT THE COIL STRETCHED DURING WITHDRAWAL FROM THE ANEURYSM. IT WAS FURTHER STATED THAT IT IS POSSIBLE THAT COIL ENTANGLEMENT WITH PREVIOUS PLACED COILS CONTRIBUTED TO THE EVENT. THE COIL WAS REPLACED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE EVENT DID NOT RESULT IN FLOW RESTRICTION/REDUCTION AND THERE WAS NO ADVERSE OUTCOME TO THE PATIENT AND. THE SURGERY WAS DELAYED THREE MINUTES DUE TO THE EVENT. NECK REMODELING WAS PERFORMED UTILIZING A SCEPTER BALLOON. THE SIZE OF THE ANEURYSM NECK WAS 2.5MM. AN ADEQUATE CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE MICROCATHETER. THERE WAS NO RESISTANCE ENCOUNTERED BETWEEN THE GUIDEWIRE AND THE MICROCATHETER WHEN ACCESSING THE TARGET SITE. THERE WAS NO RESISTANCE AT ANY TI

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7210540 ↗