MICRUSPHERERecalls & reported problems across all models

We found 22 models of MICRUSPHERE by Medos International Sàrl in the FDA's device registry (GUDID). Together they are named in 63 adverse event reports in the FDA's MAUDE database, received between Apr 1, 2015 and Apr 26, 2024 — classified as 4 injuries, 59 malfunctions.

The most frequently reported specific device problem is “Stretched” (35 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported MICRUSPHERE problems

MICRUSPHERE models

22 models, most reported first. Each model has its own page with its reports, recalls and device details.

• MICRUSPHERE SSR100825-20

  Device, Vascular, for Promoting Embolization
  6 reports
• MICRUSPHERE SPH100400-20

  DEVICE, NEUROVASCULAR EMBOLIZATION
  5 reports
• MICRUSPHERE SSR100620-20

  Device, Vascular, for Promoting Embolization
  5 reports
• MICRUSPHERE SPH100250-20

  DEVICE, NEUROVASCULAR EMBOLIZATION
  4 reports
• MICRUSPHERE SSR100720-20

  Device, Vascular, for Promoting Embolization
  4 reports
• MICRUSPHERE SSR181540-20

  Device, Vascular, for Promoting Embolization
  4 reports
• MICRUSPHERE SPH100300-20

  DEVICE, NEUROVASCULAR EMBOLIZATION
  3 reports
• MICRUSPHERE SPH100350-20

  DEVICE, NEUROVASCULAR EMBOLIZATION
  3 reports
• MICRUSPHERE SPH100500-20

  Device, Vascular, for Promoting Embolization
  3 reports
• MICRUSPHERE SPH100600-20

  Device, Vascular, for Promoting Embolization
  3 reports
• MICRUSPHERE SSR100714-20

  DEVICE, NEUROVASCULAR EMBOLIZATION
  3 reports
• MICRUSPHERE SSR181028-20

  Device, Vascular, for Promoting Embolization
  3 reports
• MICRUSPHERE SSR180927-20

  Device, Vascular, for Promoting Embolization
  3 reports
• MICRUSPHERE SSR100410-20

  DEVICE, NEUROVASCULAR EMBOLIZATION
  3 reports
• MICRUSPHERE SSR100305-20

  DEVICE, NEUROVASCULAR EMBOLIZATION
  2 reports
• MICRUSPHERE SSR100514-20

  Device, Vascular, for Promoting Embolization
  2 reports
• MICRUSPHERE SSR180825-20

  Device, Vascular, for Promoting Embolization
  2 reports
• MICRUSPHERE SSR100225-20

  DEVICE, NEUROVASCULAR EMBOLIZATION
  1 report
• MICRUSPHERE SSR100510-20

  Device, Vascular, for Promoting Embolization
  1 report
• MICRUSPHERE SSR181740-20

  Device, Vascular, for Promoting Embolization
  1 report
• MICRUSPHERE SSR181640-20

  Device, Vascular, for Promoting Embolization
  1 report
• MICRUSPHERE SSR181840-20

  DEVICE, NEUROVASCULAR EMBOLIZATION
  1 report

Recent MICRUSPHERE adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionApr 26, 2024Fracture; Fracture

  AS REPORTED BY THE FIELD, THIS WAS A COIL EMBOLIZATION TO A LEFT ANTERIOR COMMUNICATING ARTERY ANEURYSM (ACOMM) WITH HIGH TORTUOSITY. THE PHYSICIAN ATTEMPTED TO COIL ANEURYSM INITIALLY WITH ONLY COILS. FIRST COIL WAS A UNIFORM 7MM X 30 CM (FCX100730, 31127140). THIS SPECIFIC ANEURYSM HAD A LEDGE TOWARDS THE NECK OF THE ANEURYSM THAT CAUSED A HEADWAY DUO 156CM MICROCATHETER (MC) TO BECOME UNSTABLE. BECAUSE OF THE LEDGE, BECAUSE OF THE FORCE NEEDED TO ADVANCE THE COIL INTO THE ANEURYSM, THE COIL FRACTURED AT THE JUNCTION OF THE COIL AND THE PUSHER WIRE. THE 5 FR SOFIA WAS ADVANCED AND THE COIL WAS TAKEN OUT WITH THE MICROCATHETER AS A UNIT. THE ENTIRE COIL WAS REMOVED. NEW MICROCATHETER WAS USED TO RE-ACCESS THE ANEURYSM. THE SECOND COIL, A UNIFORM 7MM X 13.9 CM (FCX100713, 31098464) WAS ADVANCED INTO THE ANEURYSM WITHOUT ANY ISSUE. ATTEMPTED TO DETACH COIL WITH MECHANICAL DETACHMENT HANDLE (MDH1, 102109430) UNSUCCESSFULLY. THE MANUAL BREAK WAS USED CORRECTLY AND THAT WAS UNSUCCESSFUL AS WELL. THAT COIL WAS REMOVED WITHOUT ANY ISSUES. A MICRUSPHERE XL 7MMX14CM COIL (SSR10071420, 30529251) WAS USED AT THIS POINT WITH THE SAME MICROCATHETER IN PLACE. THAT COIL FRACTURED AS WELL DUE TO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19197119 ↗
• 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 ↗
• 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 ↗
• MalfunctionMar 14, 2023Stretched; Premature Separation; Stretched; Premature Separation

  AS REPORTED BY THE FIELD, DURING A DISTAL POSTERIOR CEREBRAL ARTERY ANEURYSM (PCA) MEASURING AT APPROXIMATELY 20 MM IN SIZE, A MICROSPHERE XL 9MMX27CM COIL (SSR18092720, L14899) WAS ADVANCED THROUGH A HEADWAY DUO 156 CM MICROCATHETER (MC) AND STRETCHED TO THE POINT THAT THE COIL DETACHED INSIDE THE MICROCATHETER. THE PHYSICIAN ATTEMPTED TO USE A COIL PUSHER WIRE TO ADVANCE THE COIL THROUGH THE MICROCATHETER INTO THE ANEURYSM UNSUCCESSFULLY. ULTIMATELY, THE DECISION WAS MADE TO TAKE OUT THE MICROCATHETER. FORTUNATELY, THE ENTIRE COIL WAS REMOVED FROM THE BODY. A STRYKER XT17 WAS USED TO REASSESS THE ANEURYSM AND FINISHED COILING WITH 2 TARGET COILS. THIS IS CONSIDERED A VERY COMPLICATED CASE DUE TO THE LOCATION OF THE ANEURYSM. EITHER PRODUCT WAS NOT ALTERED AFTER REMOVAL, FROM THE PATIENT¿S BODY. THIS DID RESULT IN THE DELAY OF PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16536907 ↗
• MalfunctionNov 28, 2022Separation Failure; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE WITH THE BASILAR ARTERY AS THE PARENT VESSEL, THERE WERE ISSUES DETACHING TWO (2) SEPARATE COILS, A 6MM X 20CM MICRUSPHERE XL 10 (SSR10062020 / 30397660) AND A 5MM X 12CM CASHMERE 14 (SRC14051220 / 30422249) WITH THE ENPOWER CONTROL CABLE (ECB00018200 / 30798739). IT WAS REPORTED THAT THE COIL WAS PARTIALLY DETACHED DURING THE INITIAL CYCLE OF THE ENPOWER CABLE AND BOX. WHEN THE PHYSICIAN PULLED BACK ON THE DELIVERY WIRE, A PORTION OF THE COIL WAS PULLED BACK INTO THE PARENT VESSEL. BOTH TIMES, THE PORTION OF THE COIL WAS PUSHED BACK INTO THE ANEURYSM AND ANOTHER DETACHMENT CYCLE OF THE CABLE WAS PERFORMED SUCCESSFULLY. AFTER THE SECOND OCCURRENCE WITH THE DETACHMENT ISSUE, THE ENPOWER CABLE WAS REPLACED WITH A NEW ONE AND THE REST OF THE COILS USED WAS UNEVENTFUL. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15875016 ↗
• InjuryOct 1, 2022Entrapment of Device; Migration; Premature Separation; Entrapment of Device; Migration; Premature Separation

  THE HEALTHCARE PROFESSIONAL REPORTED DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE TARGETING A BASILAR FUSIFORM ANEURYSM, THE ANEURYSM WAS TREATED WITH A FRED¿ FLOW DIVERTER STENT (MICROVENTION) AND A ¿JAILED¿ MICROCATHETER INSIDE THE BODY OF THE FUSIFORM, PER THE PHYSICIAN, PART OF THE 10MM X 28CM MICRUSPHERE XL (SSR18102820 / L14675) BECAME SNAGGED WITH A TINE OF THE FLOW DIVERTER; THIS CAUSED THE COIL TO DETACH FROM THE DELIVERY WIRE OF THE COIL. ABOUT HALF OF THE COIL REMAINED IN THE PARENT VESSEL. MULTIPLE UNSUCCESSFUL ATTEMPTS WERE MADE TO CAPTURE THE COIL WITH STENT RETRIEVERS AND SNARES. ULTIMATELY, THE PHYSICIAN DECIDED TO USE ENTERPRISE STENTS TO TACK THE COIL OUTSIDE OF THE ANEURYSM TO THE WALL OF THE BASILAR ARTERY. IT WAS REPORTED THAT THE PATIENT STAYED INTUBATED POST-PROCEDURE. THE DURATION OF THE INTUBATION POST-PROCEDURE WAS NOT REPORTED. THE PATIENT TREATMENT WAS DELAYED DUE TO THE TIME TAKEN TO ATTEMPT TO EXTRACT THE COIL, HOWEVER, THE DURATION OF THE DELAY WAS NOT REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 15526053 ↗
• MalfunctionMay 16, 2022Failure to Advance; Failure to Advance

  AS REPORTED BY THE FIELD, DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE ON A MALE PATIENT, THE MICROSPHERE XL 15MM X 40CM COIL (SSR18154020, L14750) PRESENTED TECHNICAL PROBLEMS AND THERE WAS NO PROGRESSION WITHIN THE MICROCATHETER, MAKING ITS USE IMPOSSIBLE FOR THE TREATMENT OF THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE. BASED ON THE ANALYSIS OF THE DEVICE RECEIVED, THE EMBOLIC COIL WAS FOUND STRETCHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14408476 ↗
• 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 22, 2021Stretched; Stretched

  AS REPORTED BY THE FIELD, DURING A STENT-ASSISTED EMBOLIZATION FOR ANEURYSMS UNDER GENERAL ANESTHESIA, A MICRUSPHERE 10 PLAT 3.5MMX6.6CM COIL (SPH10035020, 30358389) WAS ADVANCED THROUGH AN UNSPECIFIED MICROCATHETER (MC) AND ARRIVED AT TARGET POSITION, STARTED FILLING THE ANEURYSM WITH COIL. THE PHYSICIAN OBSERVED THAT COIL WAS FOUND TO BE UNRAVELED/STRETCHED IN THE MICROCATHETER. THEN RETRACTED THE COIL TO INTRODUCER AND THE SURGEON SWITCHED TO ANOTHER DEVICE TO COMPLETE THE SURGERY. THERE WAS NO PATIENT INJURY REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12516273 ↗
• MalfunctionJun 4, 2021Separation Failure; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ANEURYSM EMBOLIZATION PROCEDURE, THE COMPLAINT COIL, AN 8MM X 25CM MICRUSPHERE XL COIL (SSR18082520 / LOT# UNKNOWN) FAILED TO DETACH. THE PHYSICIAN REPLACED THE DETACHMENT CONTROL BOX (DCB) BUT THE COIL STILL WOULD NOT DETACH. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11942776 ↗
• MalfunctionNov 20, 2020Fracture; Stretched; Fracture; Stretched

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE PROCEDURE THE PUSHER WIRE OF THE 6MM X 20CM MICRUSPHERE XL 10 STRETCH RESISTANT COIL (SSR10062020 / K10209) WOULD NOT ADVANCE THROUGH THE ROTATING HEMOSTASIS VALVE (RHV) INTO THE HUB OF THE CONCOMITANT MICROCATHETER (BRAND UNKNOWN). THE INTRODUCER SHEATH WAS INSERTED INTO THE HUB OF THE MICROCATHETER CORRECTLY. AS THE PHYSICIAN WAS PUSHING THE COIL FORWARD, THE WIRE HERNIATED THROUGH THE INTRODUCER SHEATH. THE COIL WAS REMOVED FROM THE RHV AND ANOTHER COIL OF DIFFERENT SIZE AND TYPE WAS USED WITHOUT ANY SIGNIFICANT DIFFICULTY. THE POSITION OF THE MICROCATHETER REMAINED INSIDE THE ANEURYSM. THE SAME MICROCATHETER WAS USED DURING THE ENTIRE CASE. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT OUTCOME AND THERE WAS NO SIGNIFICANT DELAY IN THE ANEURYSM TREATMENT PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE CAUSE OF THE RESISTANCE WAS NOT KNOWN. THE COMPLAINT DEVICE DID NOT APPEAR TO HAVE DAMAGE WHEN IT WAS REMOVED FROM THE PACKAGE. THERE WAS NOTHING NOTED TO BE OBSTRUCTING THE MICROCATHETER. PRIOR TO THE ISSUE ENCOUNTERED WITH THE COMPLAINT COIL, TWO OTHER COILS (A 6MMX12CM MICRUSPHERE XL 10 STRETCH RESISTANT COIL

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10880756 ↗
• 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 ↗
• 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 ↗
• 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 ↗

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