MICRUSPHERE SPH100500-20Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00878528003557), received between Sep 24, 2018 and Jan 31, 2024 — 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 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.

• MalfunctionJan 31, 2024Separation Failure; Separation Failure

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, A MSPHERE 10 PLAT 5MMX9.7CM COIL (SPH10050020, 30457133) WAS FILLED IN ANEURYSM AND TRIED TO DETACH, BUT THE COIL WAS UNABLE TO DETACH. THE PHYSICIAN RETRACTED THE COIL AND SWITCHED A NEW ONE TO COMPLETE THE SURGERY. THE MICROCATHETER WAS NOT REPLACED. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18614109 ↗
• MalfunctionJan 30, 2024Stretched; Stretched

  AS REPORTED BY THE FIELD, DURING THE PROCEDURE, THE PHYSICIAN FILLED THE ANEURYSM WITH A MSPHERE 10 PLAT 5MMX9.7CM COIL (SPH10050020, 30432678). IT WAS FOUND THAT THE COIL WAS UNRAVELED/STRETCHED. THE PHYSICIAN RETRACTED THE COIL AND SWITCHED TO A NEW ONE TO COMPLETE THE SURGERY. THE MICROCATHETER WAS NOT REPLACED. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18609938 ↗
• MalfunctionSep 24, 2018Stretched; Stretched

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A COIL EMBOLIZATION OF A 5MM UNRUPTURED MODERATELY TORTUOUS RIGHT ANTERIOR COMMUNICATING ARTERY ANEURYSM, THE 5MM X 9.7CM MICRUSPHERE 10 (SPH10050020/P10782) THERMO-MECHANICAL COIL WAS ADVANCED TO THE ANEURYSM AS THE FIRST COIL IN THE CASE, AND POSITIONED SEVERAL TIMES BUT THE PHYSICIAN WAS UNABLE TO GET THE COIL IN THE CORRECT POSITION. THE PHYSICIAN STATED THAT THE LAST TWO LOOPS OF THE COIL DID NOT FORM CORRECTLY. THE COIL WAS REMOVED FROM THE PATIENT WITHOUT ISSUE AND REPLACED WITH A 4MM X 7.5CM MICRUSPHERE 10 (SPH10040020/P10914) BUT THE SAME ISSUE OCCURRED AFTER POSITIONING THE COIL SEVERAL TIMES. THE PHYSICIAN AGAIN FELT THAT THE LAST TWO LOOPS WERE NOT FORMING LIKE THE COIL TYPICALLY DOES. THE PHYSICIAN STATED THAT HE USUALLY ACHIEVES A NICE STRUCTURE, BUT THE LOOPS DID NOT BEHAVE LIKE HE WAS USED TO WITH THE MICRUSPHERE. HE DESCRIBED THE COILS AS DEFECTIVE BUT DID NOT REPORT ANY DAMAGE/STRETCHED CONDITION. THE PROCEDURE WAS COMPLETED WITHOUT INCIDENT OR DELAY USING COMPETITOR COILS. NO PATIENT COMPLICATIONS OCCURRED AS A RESULT OF THE EVENT. THE PATIENT DID WELL POST-OPERATIVELY AND WAS DISCHARGED THE FOLLOWING DAY. APPROACH

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7904057 ↗