ReactTM REACT-71Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00847536031784), received between Aug 19, 2019 and Sep 10, 2026 — classified as 10 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (8 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 10, 2026Break; Leak/Splash

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50715909 ↗
• MalfunctionMar 19, 2026Break

  MEDTRONIC RECEIVED A REPORT THAT THE IN THE EARLY MORNING OF (B)(6), THE REPORTED HOSPITAL PERFORMED A MIDDLE CEREBRAL ARTERY M2 SEGMENT THROMBECTOMY. DURING ADVANCEMENT OF THE DISTAL ACCESS CATHETER TO THE PROXIMAL SEGMENT OF THE MIDDLE CEREBRAL ARTERY THROMBUS USING A MICRO GUIDEWIRE AND MICROCATHETER COAXIAL TECHNIQUE, THE DISTAL ACCESS CATHETER WAS NOT SHAPED, AND ASPIRATION WITH A 50 ML SYRINGE SHOWED AIR REFLUX AND INABILITY TO MAINTAIN NEGATIVE PRESSURE. THE CATHETER WAS REMOVED FOR INSPECTION, AND A RUPTURE WAS FOUND AT THE TIP END. A NEW REACT-71 WAS USED INSTEAD FOR ASPIRATION, SUCCESSFUL RECANALIZATION WAS ACHIEVED IN A SINGLE PASS, THE PATIENT WAS IN GOOD CONDITION, AND THE PROCEDURE WAS COMPLETED. THE DEVICE AND ANY ACCESSORIES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE CATHETER WAS FLUSHED AS INDICATED IN THE IFU. NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24639873 ↗
• MalfunctionSep 4, 2025Material Deformation; Material Deformation

  MEDTRONIC RECEIVED A REPORT THAT AFTER ANGIOGRAPHY, THE PATIENT WAS SUSPECTED OF ACUTE OCCLUSION OF THE LEFT INTERNAL CAROTID ARTERY. THE SURGEON CONSIDERED USING A DISPOSABLE INTRACRANIAL THROMBUS ASPIRATION CATHETER REACT-71 + THROMBECTOMY STENT TO PERFORM SWIM THROMBECTOMY FOR THE PATIENT. UNDER THE GUIDANCE OF THE MICROCATHETER REBAR-18 AND THE GUIDEWIRE AVIGO, REACT-71 SUCCESSFULLY REACHED THE PROXIMAL END OF THE OCCLUDED LESION SEGMENT, AND THE SOLITAIREX INTRACRANIAL THROMBECTOMY STENT SFR4-6-40-10 WAS SELECTED FOR IMPLANTATION. AFTER THE STENT WAS OPENED AND OBSERVED FOR 5 MINUTES, THE FIRST STENT THROMBECTOMY WAS PERFORMED UNDER THE CONTINUOUS NEGATIVE PRESSURE OF THE 20ML SYRINGE. WHEN THE REACT-71 AND THE THROMBECTOMY STENT WERE WITHDRAWN FROM THE BODY, THE SURGEON FOUND THAT THE TIP OF THE REACT-71 CATHETER WAS OBVIOUSLY NARROWED AND DEFLATED AT ABOUT 1.5CM, AND THE ENTIRE TIP OF THE CATHETER WAS NOT SMOOTH. CONSIDERING THE SAFETY OF THE SUBSEQUENT OPERATION, THE SURGEON IMMEDIATELY REPLACED THE CATHETER WITH ANOTHER REACT-71 CATHETER FOR THE SUBSEQUENT OPERATION AND REQUESTED THAT THE FIRST REACT-71 BE COMPLAINED ABOUT WITHOUT CHARGE. AFTER THE OPERATION W AS SUCCESSFU

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22968357 ↗
• MalfunctionJul 14, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT HAD OCCLUSION AT THE END OF THE INTERNAL NECK ARTERY. THE SURGEON USED A MICRO-GUIDEWIRE AND MICRO-CATHETER WITH REACT71 IN PLACE TO ASPIRATE ONCE BUT FAILED. THEN THE SURGEON PREPARED THE SFR-6-30 STENT FOR THROMBECTOMY. DURING THE STENT DELIVERY PROCESS, THE SURGEON COULD NOT PUSH IT OUT OF THE MICRO-CATHETER. AFTER SEVERAL ATTEMPTS TO PUSH THE IT OUT, IT FAILED. AFTER PULLING IT OUT, IT WAS FOUND THAT THE PUSH GUIDEWIRE AT THE TIP WAS DAMAGED AND COULD NOT BE USED ANYMORE. THE RESISTANCE WAS IN THE DISTAL SECTION OF THE CATHETER. CONTINUOUS SALINE FLUSH WAS ADMINISTERED AND MAINTAINED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE GUIDEWIRE WAS AN AVIGO. THERE WAS NO DAMAGE TO THE REACT CATHETER. ANCILLARY DEVICES: AVIGO GUIDEWIRE MODEL: 103-0606-200 LOT NO.: B812571.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Obstruction/Occlusion

  MAUDE report 22496222 ↗
• InjuryJul 16, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ADDITIONAL INFORMATION WAS RECEIVED. PATIENT SUFFERED A COMPLETED INFARCT. PER THE PHYSICIAN, HE DOES NOT BELIEVE THAT IT WAS DUE TO THE CATHETER TIP THAT WAS LEFT BEHIND. THERE WAS NO ADDED DEFICIT SECONDARY TO THE CATHETER TIP. NO ACTIONS/INTERVENTIONS WERE TAKEN TO RESOLVE THE CATHETER TIP LEFT IN PATIENT AND STROKE.

  Patient problems: Foreign Body In Patient; Ischemia; Ischemia Stroke

  MAUDE report 19751858 ↗
• MalfunctionNov 7, 2022Leak/Splash; Difficult to Advance; Physical Resistance/Sticking; Leak/Splash; Difficult to Advance; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE CATHETER WAS NOT PUNCTURED BY AN INTRALUMINAL DEVICE, AND THE INTERNAL CONSUMABLES PASSED NORMALLY. A .088" HEMO LONG SHEATH HAD RESISTANCE IN THE REACT CATHETER. A TRACLINE CATHETER WAS ALSO USED. ACCORDING TO THE INTRAOPERATIVE SITUATION, THE PRELIMINARY JUDGMENT WAS CAUSED BY THE LARGE TORTUOSITY OF THE BLOOD VESSELS, THE HIGH TENSION OF THE CATHETER, AND THE INCREASED FRICTION WITH THE EXTERNAL HEMO LONG SHEATH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15744370 ↗
• MalfunctionDec 3, 2021Stretched; Device Dislodged or Dislocated; Physical Resistance/Sticking; Stretched; Device Dislodged or Dislocated; Physical Resistance/Sticking

  MEDTRONIC RECEIVED REPORT THAT THE PHYSICIAN EXPERIENCED STRETCHING AS THE REACT-71 CATHETER WAS REMOVED FROM THE RHV WHEN COMPLETING RETRIEVAL. IT WAS NOTED THAT THERE HAD BEEN CATHETER RESISTANCE IN THE MIDDLE SEGMENT AND THE MARKER BAND WAS DISLODGED AND REMAINED IN THE PATIENT. IT WAS NOTED THE DEVICE WAS PREPARED AS FLUSHED PER THE IFU. THERE WERE NO PATIENT SYMPTOMS ASSOCIATED WITH THE EVENT. THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE TO TREAT STROKE IN A MIDDLE CEREBRAL ARTERY (MCA).

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 12924484 ↗
• InjuryAug 23, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THERE WERE NO ISSUES THAT LED TO THE MARKER BAND DISLODGEMENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 12356025 ↗
• InjuryJul 22, 2021Device Dislodged or Dislocated; Material Deformation; Physical Resistance/Sticking; Device Dislodged or Dislocated; Material Deformation; Physical Resistance/Sticking

  ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2021. THERE WAS NO PLAN TO REMOVE THE MARKER BAND IN THE FUTURE. NOTHING WAS DONE TO SECURE THE DISLODGED MARKER BAND WITHIN THE VESSEL.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 12211545 ↗
• InjuryApr 1, 2021Stretched; Deformation Due to Compressive Stress; Device Damaged by Another Device; Physical Resistance/Sticking; Stretched; Deformation Due to Compressive Stress; Device Damaged by Another Device; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT IT WAS UNCLEAR IF THE DISSECTION WAS CAUSED BY THE DEVICE, USER/TECHNIQUE ERROR, OR IF IT WAS PRE-EXISTING. THE DEVICES WERE PREPARED ACCORDING THE INSTRUCTIONS FOR USE (IFU). AS OF 26-MAR-2021 THE PATIENT WAS ALIVE AND STABLE.

  Patient problems: Vascular Dissection

  MAUDE report 11606682 ↗
• InjuryApr 1, 2021Stretched; Deformation Due to Compressive Stress; Device Damaged by Another Device; Physical Resistance/Sticking; Stretched; Deformation Due to Compressive Stress; Device Damaged by Another Device; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT IT WAS UNCLEAR IF THE DISSECTION WAS CAUSED BY THE DEVICE, USER/TECHNIQUE ERROR, OR IF IT WAS PRE-EXISTING. THE DEVICES WERE PREPARED ACCORDING THE INSTRUCTIONS FOR USE (IFU). AS OF (B)(6) 2021 THE PATIENT WAS ALIVE AND STABLE.

  Patient problems: Vascular Dissection

  MAUDE report 11606676 ↗
• InjuryJan 13, 2021Device Dislodged or Dislocated; Physical Resistance/Sticking; Device Dislodged or Dislocated; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE DOCTOR PERFORMED THE FIRST PASS WITH THE REACT CATHETER, PHENOM 27 MICROCATHETER, AND SOLITAIRE. THE MODIFIED THROMBOLYSIS IN CEREBRAL INFARCTION (MTICI) SCORE WAS 3. ON A SECOND PASS WITH THE SAME PRODUCTS, THE DOCTOR NOTICED THE REACT CATHETER TIP MARKER WAS IN THE PATIENT, AND THE MTICI SCORE WAS STILL 3. IT WAS ALSO NOTICED THERE WAS A KINK IN THE CEREBASE CATHETER WHICH THE REACT71, PHENOM 27, AND SOLITAIRE PASSED THROUGH. THE DOCTOR TRIED TO SNARE/ASPIRATE THE MARKER WITH NO SUCCESS. FINALLY, THE DOCTOR PINNED THE MARKER TO THE M1 WALL WITH A STENT WHICH TOOK TWO HOURS TO NAVIGATE THE STENT TO THE LOCATION. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A STROKE. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS HIGH.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 11167066 ↗
• MalfunctionJan 5, 2021Leak/Splash; Leak/Splash

  MEDTRONIC RECEIVED A REPORT THAT WHEN THE SURGEON FLUSHED THE CATHETER WITH SALINE PRIOR TO USE IT WAS FOUND TO BE LEAKING/CRACKED IN MULTIPLE LOCATIONS. THE CATHETER WAS NOT USED ON THE PATIENT, AND THEY DID NOT EXPERIENCE ANY INJURY OR COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11121496 ↗
• MalfunctionDec 1, 2020Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE PATIENT'S VESSEL TORTUOSITY WAS NORMAL. THERE WERE NO HARD CLOTS OR CALCIFICATIONS ON THE NAVIGATION TRACT. SOME RESISTANCE WAS FELT WHEN RETRIEVING THE DEVICE THROUGH THE CEREBRASE SHEATH, BUT NONE FELT DURING DELIVERY. THE CATHETER WAS BEING DELIVER TO THE LEFT M1 SEGMENT. THERE WAS NO RESISTANCE WHEN ADVANCING OR RETRIEVING THE REACT THROUGH THE VELOCITY CATHETER. THE VELOCITY CATHETER WAS DELIVERED TO THE M2 SEGMENT. NO RESISTANCE WAS FELT WHEN DELIVERING THE SOLITAIRE THROUGH THE VELOCITY CATHETER, BUT SOME RESISTANCE WAS FELT WHEN RETRIEVING THE SOLITAIRE THROUGH THE REACT CATHETER. ONLY 1 PASS WAS MADE WITH THE SOLITAIRE DEVICE. THE ACCORDION/FRAY OF THE REACT WAS NOTICED ONCE IT WAS OUT OF THE PATIENT. IT WAS CONFIRMED THAT A CONTINUOUS FLUSH OF SALINE WAS USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10929561 ↗
• InjuryMar 4, 2020Break; Break

  ADDITIONAL INFORMATION RECEIVED INDICATED THERE WERE ATTEMPTS MADE BY THE PHYSICIAN TO REMOVE THE BROKEN SEGMENT OF CATHETER, BUT IT WAS UNSUCCESSFUL. THE CATHETER WAS PRETTY WELL LOCKED IN PLACE AND SO NO ADDITIONAL INTERVENTION WAS PERFORMED TO SECURE IT IN PLACE. THE PATIENT DID EXPERIENCE A SLIGHT STROKE, BUT IT REMAINED UNCERTAIN HOW RELATED IT WAS TO THE DEVICE OR AN UNDERLYING CONDITION. IT WAS NOTED THE PATIENT WAS DOING WELL NOW.

  Patient problems: Device Embedded In Tissue or Plaque; Infarction, Cerebral

  MAUDE report 9785458 ↗
• InjuryMar 4, 2020Break; Break

  MEDTRONIC RECEIVED REPORT THAT THE TIP OF THE REACT CATHETER SEPARATED AND REMAINS IN THE PATIENT'S RIGHT M1. THIS EVENT OCCURRED DURING A MECHANICAL THROMBECTOMY CASE. THE PATIENT VESSEL REMAINED OPEN. TWO REACT CATHETERS WERE USED AND IT IS UNKNOWN WHICH OF THESE TWO DEVICE EXPERIENCED THE DEVICE SEPARATION. A851300 AND A824582 WERE TWO DEVICES THAT WERE USED IN THE IS CASE.

  Patient problems: Device Embedded In Tissue or Plaque; Infarction, Cerebral

  MAUDE report 9785447 ↗
• InjuryMar 2, 2020Break; Break

  MEDTRONIC RECEIVED A REPORT THAT THE REACT CATHETER TIP BROKE OFF DURING ASPIRATIONS AND WAS LEFT IN THE PATIENT. THE PIECE WAS NON-OCCLUSIVE AND TICI RESULT WAS 2. NO ADDITIONAL INFORMATION WAS PROVIDED AT THE TIME OF THE REPORT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9775268 ↗
• MalfunctionOct 22, 2019Leak/Splash; Leak/Splash

  MEDTRONIC RECEIVED REPORT THAT THE REACT 71 CATHETER WAS NOTED TO BE LEAKING AT THE DISTAL SECTION. THIS EVENT WAS NOTICE DURING THE FIRST THROMBECTOMY RETRIEVAL. THE PATIENT WAS UNDERGOING A COMBINED MECHANICAL AND ASPIRATION PROCEDURE FOR AN ACUTE ISCHEMIC STROKE. NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. THE VESSEL WAS OBSERVED TO BE SEVERELY TORTUOUS. THE DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9220630 ↗
• InjuryAug 19, 2019Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE REACT CATHETER "SHEARED OFF" WHILE THE PHYSICIAN WAS PULLING THE SOLITAIRE THROUGH IT. IT WAS NOTED THAT THE PATIENT'S ANATOMY WAS VERY TORTUOUS, AND FORCE WAS USED TO PULL THE SOLITAIRE THROUGH THE REACT. THE SHEARED PORTION OF THE REACT REPORTEDLY REMAINS INSIDE THE PATIENT. THERE WERE NO REPORTS OF PATIENT SYMPTOMS IN ASSOCIATION WITH THIS EVENT. THE DEVICES HAD BEEN PREPARED AS INDICATED IN THE IFU (INSPECTED, HYDRATED, ETC.)

  Patient problems: Foreign Body In Patient

  MAUDE report 8908772 ↗