MICRUSPHERE SPH100400-20Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00878528003540), received between Jul 19, 2017 and Jan 17, 2024 — classified as 1 injury, 4 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 16, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 17, 2024Stretched; Stretched

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, TWO COILS WERE FOUND UNRAVELED/STRETCHED, A PRESIDIO 10 CERE 6MMX26CM (PC410062630, 30422252) AND A MSPHERE 10 PLAT 4MMX7.5CM (SPH10040020, 30443972). A PRESIDIO 10 CERE 6MMX26CM COIL (B)(4) FAILED TO DETACH. NEW COILS WERE SWITCHED 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 18525821 ↗
• MalfunctionOct 4, 2021Separation Failure; Separation Failure

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, A MSPHERE 10 PLAT 4MMX7.5CM COIL (SPH10040020, 459685) COULDN¿T BE DETACHED. THE PHYSICIAN SWITCHED TO ANOTHER NEW ONE TO COMPLETE THE PROCEDURE. THERE WAS NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12568476 ↗
• MalfunctionSep 24, 2018Stretched; Material Deformation; Stretched; Material Deformation

  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 7904064 ↗
• MalfunctionSep 22, 2017Stretched; Stretched

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING THE ANEURYSM EMBOLIZATION PROCEDURE, THE MICROSPHERE COIL (SPH10040020/P10951) STRETCHED. THEY USED ANOTHER ONE TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF PATIENT INJURY. IT WAS REPORTED THAT THE DEVICE WOULD BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6885963 ↗
• InjuryJul 19, 2017Migration or Expulsion of Device; Device Damaged by Another Device; Migration or Expulsion of Device; Device Damaged by Another Device

  AS REPORTED BY A PHYSICIAN, DURING COIL EMBOLIZATION OF A 5 MM (NECK 3 MM) ANTERIOR COMMUNICATING ARTERY ANEURYSM, AFTER SUCCESSFUL DEPLOYMENT OF THE FIRST COIL, A 4 MM X 15 CM MICRUSPHERE (SPH10040020/C31600), AN ULTIPAQ 3 MM X 8 CM (CATALOG FSR10030820/C27386) MILDLY BULGED INTO THE PARENT ARTERY. IT WAS DECIDED TO WITHDRAW THE COIL; HOWEVER, WHILE TAKING IT OUT, THE COIL WAS ENTANGLED WITH THE PREVIOUS COIL, STRETCHED AND SEPARATED WITH THE PROXIMAL END SEEN IN THE THORACIC AORTA AND THE DISTAL END IN THE ANEURYSMAL CAVITY, RESULTING IN REDUCTION OF BLOOD FLOW THROUGH THE ARTERY. WHILE TAKING OUT THE EXCELSIOR SL 10 (1.7F DISTAL END) MICROCATHETER WITH THE COIL, THE WHOLE COIL MASS MOVED AND MIGRATED INTO THE PARENT ARTERY. THE ATTEMPT TO REPLACE THE COIL MASS USING A PUSHER WIRE AND MICROWIRE WERE INEFFECTIVE. THERE WAS PARTIAL REPOSITIONING BY BALLOON ANGIOPLASTY WITH A SCEPTER BALLOON; HOWEVER, THE COILS REMAINED IN THE PATIENT WITH THE PROXIMAL END OF THE ULTIPAQ FLOATING WITHIN THE THORACIC AORTA. WHEN THE PATIENT WAS EXTUBATED, SHE WAS NOT ABLE TO MOVE HER RIGHT ARM AND LEG. THE PATIENT WAS RE-CANNULATED AND FOUND TO HAVE THROMBOGENIC A1 OCCLUSION AND WAS POTENTIALLY MORE

  Patient problems: Stroke/CVA; Thrombosis; Vascular System (Circulation), Impaired

  MAUDE report 6724942 ↗