REACTRecalls & reported problems across all models

We found 2 models of REACT by Micro Therapeutics, Inc. in the FDA's device registry (GUDID). Together they are named in 89 adverse event reports in the FDA's MAUDE database, received between Jun 4, 2021 and Jan 23, 2026 — classified as 8 deaths, 29 injuries, 52 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (27 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 REACT problems

REACT models

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

• REACT™ REACT-68

  Catheter, percutaneous
  3 deaths45 reports
• REACT™ REACT-71

  Catheter, percutaneous
  5 deaths44 reports

Recent REACT adverse event reports

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

• MalfunctionJan 23, 2026Difficult to Remove; Stretched; Difficult to Advance

  ADDITIONAL INFORMATION RECEIVED CLARIFIED THAT THE PROCESS OF WITHDRAWING THE CATHETER WAS RELATIVELY SMOOTH. THE CAUSE OF THE RESI STANCE/DIFFICULT NAVIGATION WAS NOT DETERMINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24160767 ↗
• MalfunctionNov 18, 2025Difficult to Advance; Device Dislodged or Dislocated; Difficult to Advance; Device Dislodged or Dislocated

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE CAUSE OF THE MARKER BAND DISLODGEMENT WAS NOT DETERMINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23584108 ↗
• DeathOct 27, 2025Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  ADDITIONAL INFORMATION RECEIVED REPORTED THE SITE AND STUDY INVESTIGATOR CONFIRMED THERE AS NO SUBARACHNOID HEMORRHAGE PRESENT ON IMAGING. THE PATIENT DIED AT THE IN-PATIENT REHAB FACILITY. AUTOPSY RECORDS WERE NOT MAID AVAILABLE BUT THE SITE CONFIRMED THE EVENT WAS RELATED TO THE PATIENT'S PRE-EXISTING MEDICAL HISTORY OF HEART FAILURE AND WAS NOT DUE TO SUBARACHNOID HEMORRHAGE. THE PATIENT DEATH WAS UNRELATED TO THE STUDY PROCEDURE OR MEDTRONIC DEVICES USED IN THE PROCEDURE. AS THERE WAS NO DEVICE MALFUNCTION, CONFIRMED THERE WAS NO SUBARACHNOID HEMORRHAGE EVENT, AND THE PATIENT'S DEATH WAS UNRELATED TO ANY MEDTRONIC DEVICE OR THE PROCEDURE, THE EVENT NO LONGER MEETS THE DEFINITION OF A COMPLAINT PER 027-WI185. THIS EVENT IS NO LONGER A REPORTABLE EVENT. MDR DECISION CORRECTED TO NOT REPORTABLE. NO ADDITIONAL SUPPLEMENT REPORTS ARE REQUIRED UNLESS ADDITIONAL INFORMATION RECEIVED INDICATES A REPORTABLE EVENT.

  Patient problems: Intracranial Hemorrhage; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23398943 ↗
• MalfunctionSep 25, 2025Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE REACT CATHETER WAS KINKED AND RESISTANCE WAS FELT DURING WITHDRAWAL. THE PATIENT WAS UNDERGOING TREATMENT FOR A PLAQUE IN THE PROXIMAL SECTION OF THE RIGHT CAROTID ARTERY. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. THERE WAS NO CALCIFICATION. THERE WAS CHRONIC TOTAL OCCLUSION. THE PATIENT WAS ADMITTED TO THE EMERGENCY HOSPITAL WITH LEFT LIMB IMMOBILITY AND DIAGNOSED WITH ACUTE CEREBRAL INFARCTION. IT WAS REPORTED THAT A BALLOON GUIDE CATHETER WAS USED FOR PROXIMAL SUPPORT, AND A NON-MEDTRONIC GUIDEWIRE AND MICROCATHETER WERE THEN USED TO ADVANCE THROUGH THE LESION AND REACH THE DISTAL LESION. THE MICROCATHETER REACHED BEYOND THE PETROUS VALLECULA OF THE INTERNAL CAROTID ARTERY. MANUAL ANGIOGRAPHY CONFIRMED THAT THE MICROGUIDEWIRE AND MICROCATHETER WERE IN THE TRUE LUMEN AND THAT DISTAL BLOOD FLOW WAS UNOBSTRUCTED. IT WAS SUSPECTED THAT THE PATIENT'S LIMB IMMOBILITY WAS CAUSED BY A PROXIMAL ORIGIN OCCLUSION, AND RECANALIZATION OF THE ORIGIN VESSEL WAS PLANNED. THE GUIDEWIRE WAS REMOVED AND EXCHANGED WITH ANOTHER GUIDEWIRE, AND A 5 EMBOLIC PROTECTION DEVICE WAS PLANNED FOR DISTAL PROTECTION. AFTER REMOVING THE EMBOLIC PROTECTION DE

  Patient problems: Ischemia

  MAUDE report 23144753 ↗
• MalfunctionSep 12, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  ADDITIONAL INFORMATION WAS RECEIVED. IT WAS CLARIFIED THAT ONLY ONE SFR STENT WAS USED, DESPITE THE MPXR INDICATING A "SET OF STENTS" BEING RETURNED. THE ALLEGED ISSUE WAS SUSPECTED DEFORMATION NEAR THE DETACHMENT POINT; HOWEVER, THERE WAS NO BREAK OR SEPARATION OBSERVED. THERE WERE NO ISSUES DURING NAVIGATION OF THE MICROCATHETER, AND CATHETER FLUSH WAS ADMINISTERED PER IFU. THE FIRST PASS SUCCESSFULLY REACHED THETHROMBUS, AND NO FRICTION WAS ENCOUNTERED DURING DELIVERY ON EITHER THE FIRST OR SECOND PASS. NO KINK OR DAMAGE WAS OBSERVED ON THE CATHETER. IT WAS UNCLEAR IF THERE WAS ANY KINK OR DAMAGE ON THE PUSHWIRE OF THE SOLITAIRE. THE TIP OF THE SOLITAIRE SHEATH WAS SECURED INTO THE HUB OF THE MICROCATHETER. THE REACT-71 CATHETER WAS NOT USED FOR ANGIOGRAPHY BUT WAS USED AS A SUCTION AND SUPPORT CATHETER DURING SFR STENT DELIVERY, WITH A MICROCATHETER INSIDE AND THE THROMBECTOMY STENT INSIDE THE MICROCATHETER. THE CAUSES OF BOTH RESISTANCE AND DEFORMATION WERE NOT DETERMINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23042307 ↗
• MalfunctionAug 4, 2025Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT A PATIENT WAS ADMITTED TO THE OPERATING TABLE FOR AN ACUTE CEREBRAL INFARCTION. ANGIOGRAPHY REVEALED SEVERE TORTUOSITY OF THE RIGHT INTERNAL CAROTID ARTERY AND THROMBOSIS OF THE IPSILATERAL M1 MIDDLE CEREBRAL ARTERY. A 90 LONG SHEATH, FITTED WITH A REACT-68 CATHETER, MICROCATHETER, AND MICRO GUIDEWIRE, WERE PLACED AND ASPIRATION WAS PERFORMED. DURING ASPIRATION, EXCESSIVE RESISTANCE WAS FELT. AFTER UNSUCCESSFUL ATTEMPTS, IT WAS WITHDRAWN, BUT THE TIP WAS FOUND TO BE DEFORMED. A NEW CATHETER WAS SUBSEQUENTLY REPLACED. A COMBINATION OF PUMPING AND PULLING WAS USED UNTIL THE VESSEL WAS SUCCESSFULLY RECANALIZED, CONCLUDING THE PROCEDURE. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AND THE CATHETER WAS FLUSHED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT. THE PATIENT WAS UNDERGOING SURGERY FOR THROMBECTOMY OF THE RIGHT INTERNAL CAROTID ARTERY FOR ACUTE CEREBRAL INFARCTION. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS NORMAL. ACCESS VESSEL WAS THE FEMORAL ARTERY WITH AN 8MM DIAMETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22701205 ↗
• InjuryJul 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A PATIENT WHO UNDERWENT A THROMBECTOMY PROCEDURE ON (B)(6) 2024 FOR TREATMENT OF ISCHEMIC STROKE. A REACT-68 ASPIRATION CATHETER AND SOLITAIRE PLATINUM (SFR3) STENT RETRIEVER WERE USED IN THE PROCEDURE. THERE WAS NO REPORTED DEVICE MALFUNCTION. THE PATIENT'S BASELINE TICI WAS 0; NIHSS WAS 13. TICI 2B WAS ACHIEVED IN THE PROCEDURE. IT WAS REPORTED THAT IN POST-OPERATIVE IMAGING ON (B)(6) 2024, HEMORRHAGIC TRANSFORMATION OF THE INFARCT AREA WAS OBSERVED THAT HAD NOT BE NOTED IN INDEX PROCEDURE IMAGING. THERE WAS NO ADDITIONAL TREATMENT OR INTERVENTION FOR THE HEMORRHAGE EVENT AND IT WAS NOTED TO BE RESOLVING AND THE PATIENT IS RECOVERING. THE EVENT WAS NOT CONSIDERED LIFE-THREATENING AND DID NOT RESULT IN PATIENT DISABILITY, NOR DID IT PROLONG THE PATIENT'S HOSPITALIZATION. SITE ASSESSMENT CONCLUDED THE EVENT WAS NOT RELATED TO THE PROCEDURE OR MEDTRONIC DEVICES. THE MEDTRONIC STUDY SPONSOR ASSESSMENT CONCLUDED THE EVENT WAS POSSIBLY RELATED TO THE PROCEDURE. 2024-AUG-26 (B)(4) (FOR, HCP, SDY): ADDITIONAL INFORMATION WAS RECEIVED THAT THE OUTCOME WAS RECOVERED/RESOLVED ON (B)(6) 2024. ADDITIONAL INFORMATION RECEIVED REPORTED THE MRS SCORE WAS

  Patient problems: Intracranial Hemorrhage

  MAUDE report 22583138 ↗
• MalfunctionJul 21, 2025Break; Stretched; Break; Stretched

  ADDITIONAL INFORMATION RECEIVED REPORTED THE CATHETER TIP WAS STRETCHED. THERE WERE NO ISSUES THAT RESULTED IN THE DAMAGE THAT WAS FOUND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22556298 ↗
• MalfunctionJul 7, 2025Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT WHEN THE SURGEON PUSHED REACT71 INTO THE BLOOD VESSEL, HE FOUND RESISTANCE AND COULD NOT PUSH IT FORWARD AT THE KINK IN THE BLOOD VESSEL. WHEN THE SURGEON PULLED IT OUT, THEY FOUND THAT THE TIP WAS DEFORMED AND ENLARGED. THERE WAS A KINK IN THE MIDDLE. THE DEVICE AND ANY ACCESSORIES WERE PREPARED AS INDICATED IN THE IFU. THE CATHETER WAS FLUSHED AS INDICATED IN THE IFU. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A BASILAR ARTERY EMBOLISM. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. THE ACCESS VESSEL WAS THE RADIAL ARTERY WITH A DIAMETER OF 2.37. ADDITIONAL INFORMATION WAS RECEIVED REPORTING THE PATIENT WAS UNDERGOING THROMBECTOMY PROCEDURE. THE CAUSE OF THE RESISTANCE AND DAMAGE WAS NOT DETERMINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22416543 ↗
• MalfunctionJul 3, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT A SOLITAIRE ENCOUNTERED RESISTANCE IN THE MIDDLE OF THE REACT AND THE STENT PUSHWIRE WAS BROKEN IN THE DISTAL SECTION. THE PATIENT WAS UNDERGOING EMERGENCY INTERVENTIONAL THROMBECTOMY FOR TREATMENT OF ISCHEMIC STROKE IN THE MIDDLE CEREBRAL ARTERY. PATIENT CONDITION: MRS BASELINE: 4, MRS PROCEDURE: 4, NIHSS BASELINE: 15, NIHSS POST PROCEDURE: 4, TICI BASELINE: 0, TICI POST PROCEDURE: 3. IV TPA WAS NOT CONTRAINDICATED. THERE WAS 1 PASS WITH THE DEVICE. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS NORMAL. THE ACCESS VESSEL WAS THE FEMORAL ARTERY WITH AN 11MM DIAMETER. PATIENT HAS A MEDICAL HISTORY OF HYPERTENSION LEVEL 2. STROKE ONSET TO REPERFUSION TIME WAS 4.5 HOURS. IT WAS REPORTED THAT ON (B)(6) 2025, THE SURGEON WAS PERFORMING AN EMERGENCY THROMBECTOMY ON A PATIENT WITH ACUTE LARGE ARTERY OCCLUSION. THE LESION WAS LOCATED AT THE MIDDLE CEREBRAL ARTERY AT THE END OF THE INTERNAL CAROTID ARTERY. THE SURGEON PLANNED TO USE THE SOLITACT TECHNOLOGY TO REMOVE THE THROMBUS. AFTER THE MICRO-GUIDEWIRE AND MICRO-CATHETER ESTABLISHED THE PATHWAY, THE MICRO-CATHETER PERFORMED PROXIMAL AND DISTAL ANGIOGRAPHY TO DETERMINE THE PROXIMAL AND DISTAL POSITIONS O

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22394421 ↗
• MalfunctionJun 21, 2025Material Deformation; Packaging Problem; Material Deformation; Packaging Problem

  MEDTRONIC RECEIVED A REPORT THAT A REACT CATHETER WAS KINKED IN THE PROXIMAL SECTION. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF AN ISCHEMIC STROKE. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS NORMAL. THE ACCESS VESSEL WAS THE RIGHT FEMORAL ARTERY. IT WAS REPORTED THAT DURING THE LEFT MIDDLE CEREBRAL ARTERY THROMBECTOMY, WHEN THE DISTAL ACCESS CATHETER WAS UNSEALED, IT WAS FOUND THAT THE TAIL END OF THE CATHETER WAS BROKEN, AND THE CATHETER WAS REPLACED AND THE OPERATION WAS COMPLETED. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AND THE CATHETER WAS FLUSHED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED THAT THE DAMAGE WAS NOTICED WHEN OPENING THE PACKAGE AND NO FURTHER PREPARATION WAS TAKEN. IT WAS CLARIFIED THAT THE CATHETER WAS JUST KINKED. THE CAUSE OF THE DAMAGE WAS NOT DETERMINED. THERE WAS NO DAMAGE OR EVIDENCE OF TAMPERING TO DEVICE PACKAGING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22303492 ↗
• MalfunctionJun 20, 2025Break; Collapse; Packaging Problem; Break; Collapse; Packaging Problem

  MEDTRONIC RECEIVED A REPORT THAT THE MIDDLE CEREBRAL ARTERY THROMBUS WAS REMOVED. THE REACT-68 CATHETER TIP WAS FOUND TO HAVE A BREAK AND WAS NOT USED. IT WAS REPLACED WITH A NEW REACT-68 TO COMPLETE THE OPERATION. THE DISTAL END WAS ALSO REPORTED TO HAVE BEEN CRUSHED. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AND THE CATHETER WAS FLUSHED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT. THE PATIENT WAS UNDERGOING SURGERY FOR MIDDLE CEREBRAL ARTERY EMBOLECTOMY. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MINIMAL. THE ACCESS VESSEL WAS THE FEMORAL ARTERY WITH A 6MM DIAMETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22296860 ↗
• InjuryJun 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED REPORTED CAUSALITY ASSESSMENT PROVIDED AS: POSSIBLE RELATED TO PROCEDURE, NOT RELATED TO DEVICES, NOT RELATED TO DISEASE UNDER STUDY, NOT RELATED TO UNDERLYING CONDITION OR DISEASE, THE RATIONALE FOR THE RELATIONSHIP TO SYSTEM OR PROCEDURE: IT SEEMS THE THROMBUS WAS DISLODGED AND MIGRATED DURING REMOVAL.

  Patient problems: Embolism/Embolus

  MAUDE report 22208746 ↗
• MalfunctionJun 5, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT DURING THE DELIVERY THE SOLITAIRE FR STENT ENCOUNTERED RESISTANCE IN THE MIDDLE OF THE CATHETER. THE STENT DELIVERY WAS DIFFICULT AND THE CAUSE OF RESISTANCE WAS UNCLEAR. THE PATIENT WAS UNDERGOING TREATMENT FOR ISCHEMIC STROKE FROM THE END OF THE INTERNAL CAROTID ARTERY TO THE MIDDLE CEREBRAL ARTERY M1. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MINIMAL. THE PATIENT'S BASELINE MODIFIED RANKIN SCALE (MRS) SCORE WAS 4, WHICH REMAINED THE SAME FOLLOWING THE PROCEDURE. THE NATIONAL INSTITUTES OF HEALTH STROKE SCALE (NIHSS) SCORE SIGNIFICANTLY IMPROVED, DECREASING FROM A BASELINE SCORE OF 19 TO 3 POST-PROCEDURE. THE THROMBOLYSIS IN CEREBRAL INFARCTION (TICI) SCORE ALSO IMPROVED FROM 0 AT BASELINE TO 3 POST-PROCEDURE. INTRAVENOUS TISSUE PLASMINOGEN ACTIVATOR (IV TPA) WAS NOT CONTRAINDICATED IN THIS CASE. THE PROCEDURE INVOLVED TWO PASSES WITH THE DEVICE. THE STROKE ONSET TO REPERFUSION TIME WAS 4 HOURS. IT WAS REPORTED THAT THE SURGEON WAS PERFORMING AN EMERGENCY THROMBECTOMY SURGERY. THE SURGEON USED THE SOLITACT TECHNOLOGY, REACT71 CATHETER AND RUIKANGTONG MICROCATHETER, AFTER DETERMINING THE DISTAL AND PROXIMAL POSITIONS, THEY DELIVERED THE STEN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22150966 ↗
• MalfunctionJun 5, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT ON (B)(6) 2025, HEALTHCARE PROVIDER (HCP) WAS PERFORMING AN EMERGENCY THROMBECTOMY. THE PATIENT WAS AN ACUTE LARGE ARTERY OCCLUSION PATIENT WITH THE LESION AT THE TERMINAL OF THE INTERNAL CAROTID ARTERY. THE SURGEON PLANNED TO USE THE SOLITACT TECHNOLOGY FOR THROMBECTOMY. AFTER THE MICRO-GUIDEWIRE MICRO-CATHETER ESTABLISHED THE ACCESS, THE MICRO-CATHETER PERFORMED PROXIMAL AND DISTAL ANGIOGRAPHY TO CLARIFY THE PROXIMAL AND DISTAL POSITIONS OF THE THROMBECTOMY AND PREPARE TO DELIVER THE THROMBECTOMY STENT. THE STENT SELECTED WAS SFR-6-30. THE SURGEON REPORTED THAT DURING THE PUSH PROCESS, THERE WAS GREAT RESISTANCE NEAR THE Y VALVE. THE SURGEON TRIED TO INCREASE THE FORCE TO PUSH, BUT THE RESISTANCE WAS STILL GREAT. THE SURGEON WITHDREW THE STENT, PERFORMED SECONDARY HYDRATION, AND PUSHED AGAIN, BUT THE SAME RESISTANCE PHENOMENON STILL OCCURRED. FOR THE SAKE OF SURGICAL SAFETY, THE SURGEON DID NOT PUSH THE STENT WITH BRUTE FORCE, WITHDREW THE STENT, AND OBSERVED THE STENT BODY MORPHOLOGY. THE SURGEON BELIEVED THAT THE STENT HAD SOME MORPHOLOGICAL CHANGES. FOR THE SAKE OF SURGICAL SAFETY, DELIVERING THE STENT AGAIN MAY INCREASE THE RISK. THE SURGEON T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22150651 ↗

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