Sofia 5F-125cm STR DA5125STRecalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00810170019234), received between Feb 10, 2017 and May 21, 2025 — classified as 10 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Contamination” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryMay 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED THROUGH THE RESTORE CLINICAL STUDY: MULTIPLE SMALL INFARCTS: ON THE PATIENT POST-THROMBECTOMY MRI IT WAS NOTED "SCATTERED SMALL PUNCTATE CORTICAL FOCI OF RESTRICTED DIFFUSIVITY THROUGHOUT THE RIGHT FRONTAL, RIGHT PARIETAL AND RIGHT INSULAR LOBES AS WELL AS THE RIGHT OCCIPITAL LOBE AND RIGHT CAUDATE HEAD. MINIMAL ASSOCIATED CYTOTOXIC EDEMA. NO HEMORRHAGIC TRANSFORMATION." PATIENT HAS NO RESIDUAL SYMPTOMS AND WAS DISCHARGED FROM HOSPITAL TO PRIOR LIVING ARRANGEMENT LATER ON THE SAME DAY. OVER THE COURSE OF HER HOSPITALIZATION, HER DEFICITS RESOLVED. RESOLVED WITHOUT SEQUELAE. NO DIAGNOSTIC PROCEDURES WERE PERFORMED FOLLOWING THE EVENT. THE SEVERITY OF THE EVENT WAS CLASSIFIED AS MILD. THE INDEX PROCEDURE WAS PERFORMED THE DAY BEFORE. THE EVENT WAS ADJUDICATED AS POSSIBLY RELATED TO THE SOFIA DEVICE AND MECHANICAL THROMBECTOMY PROCEDURE AND DEFINITELY RELATED TO THE STUDY DISEASE.

  Patient problems: Ischemia

  MAUDE report 22058657 ↗
• MalfunctionMar 24, 2025Contamination; Contamination

  ADDITIONAL INFORMATION RECEIVED REPORTED: THE PHYSICIAN STATED THAT THE FOREIGN MATERIAL WAS ¿GREEN COLORED¿. IT WAS DISCOVERED WHEN THEY WERE INTRODUCING THE SOFIA 5 FR INTO THE RHV. THEY STOPPED AND UTILIZED ANOTHER CATHETER. NO OTHER DEVICE WAS USED INSIDE THE CATHETER WITH ANY RESISTANCE. BEFORE A PHYSICIAN UTILIZES A CATHETER; IT IS STANDARD PROCEDURE TO FLUSH THE CATHETER ON THE BACK TABLE. A THEORY IS THAT MAYBE THIS ¿MATTER¿ WAS PUSHED FORWARD ¿ ONLY AN OPINION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21682146 ↗
• InjuryMar 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH THE RESTORE CLINICAL TRIAL, A STENT RETRIEVER PASSED WITH A LOT OF TRACTION ON VESSEL RESULTED IN INTRACRANIAL HEMORRHAGE (IH TYPE 2). REPORTEDLY, DECOMPRESSIVE HEMICRANIECTOMY INTERVENTION WAS PERFORMED. THE ADVERSE EVENT RESOLVED ON (B)(6) 2024 WITH SEQUELAE NIHSS = 7. EVENT DESCRIBED AS RELATED TO CONCURRENT CONDITION/TREATMENT SPECIFIED AS STROKE. SEVERITY INDICATED AS MODERATE. THE EVENT WAS ADJUDICATED BY CLINICAL REVIEW COMMITTEE (CES) AS SAH NOT HI2. EVENT ASSESSED AS POSSIBLY RELATED TO SOFIA DEVICE; NOT RELATED TO ERIC OR BOBBY DEVICES; DEFINITELY RELATED TO THROMBECTOMY PROCEDURE; POSSIBLY RELATED TO STUDY DISEASE AND CONCURRENT CONDITION/TREATMENT. THE PATIENT HAD CLINIC VISIT ON (B)(6) 2024 FOR 90-DAY FOLLOW-UP. PATIENT WAS LIVING IN A NURSING HOME. NEURO EVALUATION WAS NIHSS OF 7; MRS WAS 3. THE PATIENT EXITED STUDY ON (B)(6) 2024.

  Patient problems: Intracranial Hemorrhage

  MAUDE report 21670750 ↗
• InjuryNov 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED IN THE RESTORE CLINICAL STUDY THAT THE PATIENT, WITH ACTIVE CANCER TREATMENT AND KNOWN THROMBOCYTOPENIA, WAS ADMITTED WITH ACUTE STROKE AND RECEIVED THROMBOLYTIC PRIOR TO ARRIVAL AT TREATMENT HOSPITAL. AN INTRA-PARENCHYMAL HEMORRHAGE NOTED WITH ONSET ON THE DAY OF INDEX PROCEDURE ON (B)(6) 2024. THE THROMBECTOMY WAS SUCCESSFUL, BUT PATIENT WAS INTUBATED FOR INCREASED RESTLESSNESS AND AGITATION. POST PROCEDURE IMAGING IDENTIFIES NEW EXTENSIVE AREA OF PARENCHYMAL HEMORRHAGE IN THE RIGHT FRONTOTEMPORAL REGION MEASURING UP TO 2.7CM, NO SIGNIFICANT MIDLINE SHIFT, AND SMALL VOLUME INTRAVENTRICULAR SUBARACHNOID HEMORRHAGE THROUGHOUT LEFT CEREBRAL CONVEXITY, TRACKING OVER TO RIGHT CEREBRAL CONVEXITY AS WELL. PLATELETS AND FRESH FROZEN PLASMA INFUSED. REPEAT IMAGING SHOWS AREA OF HEMORRHAGE STABLE. THE SITE REPORTED THE ADVERSE EVENT AS MODERATE SEVERITY, RELATED TO CONCURRENT CONDITION OF STATUS POST TNK PRIOR TO PROCEDURE, AND ASSOCIATED LOW PLATELET COUNT DUE TO CANCER TREATMENT WITH OUTCOME OF ONGOING. THE SITE ADJUDICATED THE ¿INTRACEREBRAL HEMORRHAGE¿ AS A SERIOUS ADVERSE EVENT MODERATE IN SEVERITY, POSSIBLY RELATED TO STUDY DISEASE, AND DEFINITELY RELATED TO CONCURREN

  Patient problems: Intracranial Hemorrhage; Ischemia

  MAUDE report 20616577 ↗
• InjuryJun 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED THROUGH THE SOFAST CLINICAL TRIAL (EVENT -002), THE SUBJECT WAS TAKEN TO THE ANGIOGRAPHY SUITE FOR MECHANICAL THROMBECTOMY FOR A RIGHT TEMPORAL M2 OCCLUSION ON (B)(6) 2023. AFTER THE INITIAL PASS, THE OCCLUDED TEMPORAL M2 WAS OPEN BUT RESIDUAL OCCLUSION OF A SUPERIOR/PARIETAL BRANCH REMAINED. A SECOND PASS WAS MADE WHICH OPENED UP THE M3 BUT THERE WAS A RESIDUAL M4 OCCLUSION. THIS WAS LEFT ALONE PER THE OPERATIVE NOTE. CONTROL ANGIOGRAPHY AFTER THE SECOND PASS SHOWED DELAYED FILLING OF A PARIETAL WEDGE BUT REASONABLE RETROGRADE FILLING. INDEPENDENT REVIEWING COMMITTEE CEC AND ADJUDICATED AS RELATED POSSIBLY TO DEVICE, DEFINITELY TO PROCEDURE. ADDITIONAL INFORMATION INDICATED: NO INTERVENTION WAS PERFORMED. THE PATIENT WAS SUCCESSFULLY EXTUBATED. ON EVALUATION THE PATIENT CONTINUES TO HAVE RIGHT GAZE PREFERENCE ALTHOUGH NEGLECT SEEMS SLIGHTLY IMPROVED. STILL WITH LEFT FACIAL DROOP AND RIGHT HEMIPARESIS. NEW INFORMATION INDICATED: EVENT -004: SUBARACHNOID HEMORRHAGE. EVENT DATE: (B)(6) 2024 A POST-THROMBECTOMY CT DONE ON (B)(6) 2023 SHOWED A SUBARACHNOID HEMORRHAGE. FOLLOW-UP CTS DONE ON (B)(6) 2023 AND 02DEC2023 SHOWED UNCHANGED SUBARACHNOID HEMORRHAGE AND NO NEW HEMORRH

  Patient problems: Embolism/Embolus; Hemorrhagic Stroke; Obstruction/Occlusion

  MAUDE report 19630237 ↗
• InjuryDec 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT ENROLLED IN THE SOFAST CLINICAL STUDY WAS HAVING A THROMBECTOMY PERFORMED WHEN A FRAGMENT OF A CLOT IN THE M2 SEGMENT OF THE MIDDLE CEREBRAL ARTERY MIGRATED DISTALLY AFTER ASPIRATION. THERE WAS NO INTERVENTION AND IT WAS REPORTED TO HAVE RESOLVED WITHOUT SEQUELAE THE SAME DAY. NO DIAGNOSTIC PROCEDURES WERE PERFORMED. THE PATIENT¿S NIHSS SCORE IMPROVED TO 14 THE FOLLOWING DAY FROM THEIR BASELINE SCORE OF 23 AND IMPROVED TO A SCORE OF 2 ON OCTOBER 9TH.

  Patient problems: Thromboembolism

  MAUDE report 18315257 ↗
• InjuryNov 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PHYSICIAN WAS PERFORMING A STENT/COIL PROCEDURE FROM THE RADIAL ARTERY. A COMPETITOR CATHETER WAS USED FOR ACCESS. A SOFIA CATHETER WAS THEN ADVANCED INTO THE M1 SEGMENT. A COMPETITOR MICROCATHETER AND A COMPETITOR GUIDEWIRE WERE ADVANCED TO DEPLOY A COMPETITOR STENT IN A1 SEGMENT. THE PATIENT EXPERIENCED AN INFLAMMATORY RESPONSE WITH RIGHT HEMI PERESIS AND EXTENSIVE EDEMA WITH NO INFARC. IT IS UNKNOWN WHAT INTERVENTION WAS PERFORMED. THE PATIENT WAS REPORTED AS STABLE AND DOING MUCH BETTER.

  Patient problems: Inflammation; Paresis; Swelling/ Edema

  MAUDE report 18179167 ↗
• InjuryNov 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO ADDITIONAL INFORMATION WAS RECEIVED.

  Patient problems: Obstruction/Occlusion; Stroke/CVA

  MAUDE report 18112839 ↗
• MalfunctionJul 30, 2021Stretched; Stretched

  IT WAS REPORTED THAT DURING ASPIRATION WITH A SOFIA ASPIRATION CATHETER AND MECHANICAL THROMBECTOMY WITH A STRENT RETRIEVER, THE SOFIA'S INNER WIRE WAS PULLED OUT OF THE LUMEN. THERE WAS NO REPORTED PATIENT INJURY OR INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12250804 ↗
• InjuryMay 13, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT TREATMENT OF THE POSTERIOR FOSSA A SCEPTER MINI BALLOON CATHETER WAS TRACKED THROUGH A SOFIA 5F 125CM CATHETER TO THE RIGHT VERTEBRAL ARTERY AND POSTERIOR INFERIOR CEREBELLAR ARTERY (PICA) BIFURCATION. THE SCEPTER MINI WAS INFLATED IN THE PICA. ONYX WAS INJECTED THROUGH THE SCEPTER MINI TO EMBOLIZE A TUMOR OF THE POSTERIOR FOSSA. THE ONYX REFLUXED AROUND THE BALLOON TO A LEVEL 2MM PROXIMAL TO THE SCEPTER MINI'S PROXIMAL BALLOON MARKER. THE SCEPTER MINI WAS PULLED OUT OF THE CAST BUT THE SCEPTER MINI COULD NOT BE WITHDRAWN FROM THE ONYX CAST. THE SOFIA 5F WAS TRACKED INTO THE PICA TO SUPPORT THE REMOVAL OF THE SCEPTER MINI, HOWEVER BOTH BECAME IRREMOVABLE AND THE PATIENT WAS MOVED TO NEUROSURGERY FOR ASSISTANCE WITH REMOVAL OF THE SCEPTER MINI AND SOFIA AND THE PLANNED EXCISION OF THE TUMOR WAS BROUGHT FORWARD TO BE CARRIED OUT DURING THE CRANIOTOMY. PATIENT HAD SURGICAL INTERVENTION PERFORMED BY CRANIOTOMY IN NEUROSURGERY TO REMOVE THE CATHETERS. THE PATIENT WAS COMATOSE FOR 3 DAYS POST NEUROSURGICAL EXCISION OF THEIR TUMOR POST-EMBOLIZATION. AS OF THE (B)(6), 11 DAYS POST OP, THE PATIENT IS WEAK AND HAS NOT FULLY WOKEN UP.

  Patient problems: Coma

  MAUDE report 11823283 ↗
• MalfunctionMay 13, 2021Obstruction of Flow; Device Damaged by Another Device; Device Damaged by Another Device

  IT WAS REPORTED THAT DURING THE PROCEDURE PATIENT DEVELOPED AN OCCLUSION OF THE BASILAR ARTERY. WHEN THE SOLITAIRE RETRIEVER WAS PULLED BACK, THE PHYSICIAN FELT SOME RESISTANCE. AFTER THE RETRIEVER WAS PULLED OUT, THE BRAIDING OF THE SOFIA CATHETER WAS EXTRACTED TOGETHER WITH THE RETRIEVER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11816613 ↗
• InjuryApr 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT STENT-ASSISTED COILING WAS PERFORMED IN (B)(6) 2019 FOR A RUPTURED A-COM ANEURYSM. THREE MONTHS AFTER THE PROCEDURE, COILING OF RESIDUAL ANEURYSM WAS ATTEMPTED AND THE SOFIA WAS ADVANCED THROUGH THE PRE-EXISTING STENT. A FOLLOW-UP ANGIOGRAM DEMONSTRATED A VESSEL DISSECTION IN THE ARTERIAL WALL BEHIND THE PRE-EXISTING STENT AFTER THE SOFIA WAS PUT INTO POSITION WITHIN IT. ANOTHER STENT WAS IMPLANTED WITHIN THE PRE-EXISTING STENT AND SUBSEQUENT ANGIOGRAPHY DEMONSTRATED SUCCESSFUL TREATMENT OF THE DISSECTION. THERE WAS NO REPORTED CLINICAL SEQUELA.

  Patient problems: Vascular Dissection

  MAUDE report 9925513 ↗
• InjuryFeb 10, 2017Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT TREATMENT WAS PERFORMED ON A PATIENT WHO HAD SUFFERED AN MCA STROKE 2 DAYS BEFORE THE PROCEDURE. ASPIRATION THROMBECTOMY WAS SUCCESSFULLY PERFORMED FOUR TIMES IN AN OCCLUDED LEFT CAROTID ARTERY BIFURCATION WITH A SOLITAIRE REVASCULARIZATION DEVICE USING A REBAR CATHETER AND A SOFIA CATHETER. SMALL PIECES OF THROMBUS WERE RETRIEVED FROM THE ARTERY. DURING REMOVAL OF THE SOLITAIRE AND REBAR THROUGH THE SOFIA, RESISTANCE WAS ENCOUNTERED. THE POSITION OF THE SOFIA WAS CHANGED, AND THE SOLITAIRE AND REBAR WERE THEN EASILY REMOVED THROUGH THE SOFIA. UPON REMOVAL, THE SOLITAIRE APPEARED UNDAMAGED; HOWEVER, THE REBAR CATHETER WAS EXAMINED WITH A LOUPE AND THE TIP OF THE REBAR WAS NOTED TO BE TATTERED. THE SOFIA WAS REMOVED FROM THE PATIENT THROUGH A DESTINATION GUIDING SHEATH. UPON REMOVAL, THE SOFIA CATHETER APPEARED TO HAVE A 3CM FLATTENED SEGMENT APPROXIMATELY 4CM PROXIMAL TO THE FLEXIBLE DISTAL TIP. SUBSEQUENT FLUOROSCOPIC IMAGES DEMONSTRATED A SMALL RADIOPAQUE "PIECE" IN THE CAROTID SIPHON AND A MOMENT LATER, THE PIECE "DISAPPEARED." THE EXTERNAL CAROTID ARTERY (ECA) WAS NOTED TO HAVE AN ANOMALY IN THE REGION OF THE BIFURCATION SO THE DESTINATION SHEATH MAY HAVE R

  Patient problems: Death

  MAUDE report 6321280 ↗