ReactTM REACT-68Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00847536031777), received between Nov 14, 2018 and Nov 14, 2022 — classified as 2 deaths, 2 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Break” (9 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 14, 2022Break; Break

  MEDTRONIC RECEIVED A REPORT THAT THE SOLITAIRE 4/40 WAS PLACED IN THE M2 REGION OF THE PATIENT. THE REACT 68 WAS ADVANCED OVER SOLITAIRE WIRE INTO THE M2 REGION TO ENGAGE CLOT. BOTH DEVICES WERE REMOVED TOGETHER UNDER SUCTION. THE PHYSICIAN NOTICED THE SOLITAIRE HAD BEEN TWISTED INSIDE REACT BUT OTHERWISE WAS INTACT. A SECOND PASS WAS ATTEMPTED WITH THE SAME REACT 68 BUT A NEW SOLITAIRE 4/40. THE SAME POSITION IN THE M2 WAS ACHIEVED. THE PHYSICIAN AGAIN REMOVED BOTH DEVICES. TICI 3 WAS ACHIEVED BUT THE PHYSICIAN NOTICED THE DISTAL END OF THE REACT WAS COMPROMISED. THE PHYSICIAN CONFIRMED THERE WERE NO CATHETER FRAGMENTS IN PATIENT AND ENDED THE CASE. CATHETER SEPARATION/BREAK OCCURRED IN THE DISTAL SECTION DURING USE. THERE WAS NO FRICTION OR DIFFICULTY DURING INJECTION. THERE WAS NO FORCE APPLIED DURING DELIVERY OR REMOVAL.  THE CATHETER TIP WAS NOT ENTRAPPED/STUCK. THERE WAS NO VASOSPASM. THE CATHETER WAS NOT STUCK INSIDE THE GUIDE CATHETER. THERE WAS NO SURGICAL OR MEDICINAL INTERVENTION REQUIRED. BROKEN SEGMENTS WERE REMOVED FROM THE PATIENT. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE IFU. THE CATHETER WAS FLUSHED AS INDICATED IN THE IFU. NO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15788833 ↗
• DeathOct 19, 2022Break; Device Dislodged or Dislocated; Physical Resistance/Sticking; Break; Device Dislodged or Dislocated; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE DISTAL TIP OF THE REACT 68 CATHETER BROKE OFF AFTER 2 PULLS OF THE SOLITAIRE AND LODGED IN THE VESSEL. ATTEMPTS TO RETRIEVE IT WERE UNSUCCESSFUL. THE PATIENT INCURRED A BRAIN BLEED DURING THE PROCEDURE AND LATER DIED. THE PATIENT WAS UNDERGOING A MECHANICAL THROMBECTOMY FOR A STROKE. THE ACCESS VESSEL WAS THE FEMORAL ARTERY. IT WAS REPORTED THAT RESISTANCE WAS ENCOUNTERED DURING THE PROCEDURE. THE DEVICE WAS REMOVED, AND THE TIP OF THE CATHETER WAS FRACTURED. SUBSEQUENT CEREBRAL ANGIOGRAPHY AND FLUOROSCOPY LOCATED THE TIP OF THE CATHETER IN THE LEFT INTERNAL CAROTID ARTERY BIFURCATION. AFTER ATTEMPTS TO REMOVE THE TIP WERE UNSUCCESSFUL, CT IMAGING SHOWED INCREASING CONSPICUITY IN THE VERY LARGE ACUTE LEFT MIDDLE CEREBRAL ARTERY AND MODERATE ACUTE ANTERIOR DIVISION LEFT ANTERIOR CEREBRAL ARTERY DISTRIBUTION INFARCT. THERE WAS HEMORRHAGIC CONVERSION WITH MODERATE TO LARGE ACUTE HEMATOMA CENTERED ON THE LEFT BASAL GANGLIA/INTERNAL CAPSULE AND INSULA WITH MILD SUBARACHNOID HEMORRHAGE ALONG THE LEFT SYLVAN FISSURE. THERE WAS MODERATE INTERVAL INCREASE IN MASS EFFECT WITH INCREASING LEFT-TO-RIGHT MIDLINE SHIFT FROM 3 TO 8MM. HEALTH EFFECTS INCLUDED HE

  Patient problems: Device Embedded In Tissue or Plaque; Hematoma; Intracranial Hemorrhage; Obstruction/Occlusion; Perforation of Vessels

  MAUDE report 15636703 ↗
• MalfunctionAug 18, 2022Break; Break

  MEDTRONIC RECEIVED A REPORT THAT THE REACT 68 CATHETER BROKE. THE PATIENT WAS UNDERGOING TREATMENT FOR ACUTE ISCHEMIC STROKE. THE PATIENT'S VESSEL TORTUOSITY WAS NORMAL. THE ACCESS VESSEL WAS THE RIGHT ICA, WHICH WAS 4.5MM IN DIAMETER. IT WAS REPORTED THAT THE PATIENT UNDERWENT A THROMBECTOMY AND MANUAL SUCTION WAS PERFORMED USING A SYRINGE. THE PROXIMAL PART OF REACT 68 CATHETER BROKE WHILE REMOVING THE ENTIRE SYSTEM. AS A RESULT, THE DOCTOR HAD TO USE A DIFFERENT REACT WHEN PERFORMING ASPIRATION ONCE MORE. THERE WAS NO FRICTION/DIFFICULTY DURING INJECTION, NO FOR WAS WAS APPLIED DURING DELIVERY OR REMOVAL, THE CATHETER TIP WAS NOT ENTRAPPED/STUCK, THERE WAS NO VASOSPASM, THE CATHETER WAS NOT STUCK INSIDE THE GUIDE CATHETER, AND NO ADDITIONAL MEDICAL/SURGICAL INTERVENTION WAS REQUIRED. THE PATIENT DID NOT EXPERIENCE ANY INJURY. THE DEVICES WERE PREPARED AND FLUSHED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). ANCILLARY DEVICES INCLUDE A FLOWGATE 8F GUIDE CATHETER AND A PHENOM 21 MICROCATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15251494 ↗
• InjuryJun 10, 2022Break; Difficult to Remove; Device Dislodged or Dislocated; Break; Difficult to Remove; Device Dislodged or Dislocated

  MEDTRONIC RECEIVED A REPORT THAT THE REACT-68 DISTAL MARKER WAS SEPARATED DURING THE 3RD PASS WITH THE SOLITAIRE 4X40 AT THE M1/M1 B IFURCATION WHICH WAS THE LOCATION OF THE CLOT. THE DISTAL MARKER DISK WAS CONFIRMED IN THE VESSEL USING FLUOROSCOPY. AN ADDITIONAL SOLITAIRE 4X40 WAS USED TO MAKE 3 MORE PASSES TO FISH THE DISTAL MARKER DISK OUT OF THE PATIENT USING ANOTHER REACT-68 AND CELLO. THE SYSTEM WAS REMOVED TO CONCLUDE THE CATHETER. THERE WAS NO FORCE APPLIED DURING DELIVERY OR REMOVAL. THE CATHETER TIP WAS ENTRAPPED/STUCK. THERE WAS NO VASOSPASM AND THE CATHETER WAS NOT STUCK INSIDE THE GUIDE CATHETER. SURGICAL OR MEDICINAL INTERVENTION WAS REQUIRED. THE DEVICES WERE PREPARED AS INDICATED IN THE IFU. THE CATHETER WAS FLUSHED AS INDICATED IN THE IFU. THE PATIENT WAS UNDERGOING TREATMENT FOR AN ACUTE ISCHEMIC STROKE. THE PATIENT HAD MODERATE VESSEL TORTUOSITY. ANCILLARY DEVICES INCLUDE: CELLO9FR SHEATH, REACT-68 GUIDE CATHETER, MARKSMAN MICROCATHETER, AND ASAHI CHICKAI GUIDEWIRE.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 14652668 ↗
• InjurySep 17, 2020Break; Break

  MEDTRONIC RECEIVED A REPORT THAT THE REACT 68 CATHETER FRACTURED IN THE PATIENT, AND THE SEGMENT WAS REMOVED VIA SURGICAL INTERVENTION. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF ACUTE RIGHT M1 STROKE. IT WAS REPORTED THAT THE SOLITAIRE AND ANCILLARY DEVICES WERE PREPARED AND DEPLOYED PER THE INSTRUCTIONS FOR USE (IFU), AND THEN THE SOLITAIRE WAS BROUGHT UP TO THE REACT CATHETER TO START ASPIRATION. IT WAS THEN NOTICED THE REACT CATHETER HAD BECOME FRACTURED AT THE DISTAL END. THE PHYSICIAN TRIED TO REMOVE THE ENTIRE SYSTEM, BUT THE END OF THE CATHETER REMAINED INSIDE THE PATIENT. THE M1 WAS NOW OPEN AND FREE OF CLOT AT THIS POINT. ANOTHER SOLITAIRE WAS USED TO TRY AND RETRIEVE THE CATHETER PIECE, BUT IT WAS UNSUCCESSFUL. AFTER SEVERAL ATTEMPTS, THE PHYSICIAN WAS ABLE TO REMOVE THE CATHETER FROM THE CEREBRAL CIRCULATION, BUT IT BECAME LODGED IN THE RIGHT RADIAL ARTERY. IT WAS DECIDED THE BEST WAY TO REMOVE THE CATHETER WAS BY WAY OF SURGICAL CUT DOWN. THIS WAS SUCCESSFUL, AND THE FRACTURED CATHETER WAS REMOVED FROM THE PATIENT. THE ARTERY WAS CLOSED WITHOUT ISSUE AND THE PATIENT WAS DOING VERY WELL AND SHOWED RECOVERY OF THE M1 STROKE THEY PRESENTED WITH. NO ADDITIONAL ISS

  Patient problems: Device Embedded In Tissue or Plaque; Foreign Body In Patient

  MAUDE report 10547898 ↗
• MalfunctionMar 9, 2020Break; Break

  MEDTRONIC RECEIVED REPORT THAT UPON RETRIEVING THE REACT 68 FROM WITH THE PATIENT, THE CATHETER TIP SEPARATED IN THE TOUHY. THE DEVICES WERE PREPARED AND USED PER THE INSTRUCTIONS FOR USE (IFU). NO PATIENT INJURY OCCURRED. A NAVIENCATHETER WAS USED TO COMPLETE THE PROCEDURE. ADDITIONAL INFORMATION RECEIVED INDICATED THE BROKEN SEGMENT OF THE REACT CATHETER WAS RETRIEVED FROM THE PATIENT SUCCESSFULLY. THERE WERE NO PROBLEMS/DIFFICULTIES DURING THE PROCEDURE PRIOR TO THE SEPARATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9804101 ↗
• MalfunctionMay 14, 2019Break; Break

  MEDTRONIC RECEIVED REPORT THAT WHILE THE REACT 68 WAS BEING ADVANCED INTO THE RHV IT BENT AND FRACTURED. A CONTINUOUS FLUSH WAS USED. THE REACT 68 WAS REMOVED AND ANOTHER REACT 68 WAS USED SUCCESSFULLY. NO PATIENT INJURY OCCURRED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8610014 ↗
• MalfunctionFeb 7, 2019Stretched; Physical Resistance/Sticking; Stretched; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT OF REACT CATHETER THAT TIP UNRAVEL DURING RETRIEVAL OF SOLITAIRE STENT. THE REACT CATHETER TIP DID NOT SEPARATED. THE PATIENT UNDERWENT THROMBECTOMY TREATMENT FOR A STROKE. THE VESSEL WAS OBSERVED MODERATELY TORTUOUS. IT WAS REPORTED THAT UPON ATTEMPTED TO RETRIEVE SOLITAIRE MUCH RESISTANCE WAS FELT. DECIDED TO TAKE SOLITAIRE AND REACT OUT. WAS NOT ICED THAT TIP REACT HAD UNRAVELED. THE DISTAL PART OF THE CATHETER FOUND UNRAVEL. ONLY ONE PAS MADE WITH SOLITAIRE STENT. THERE WERE NO REPORTS OF PATIENT INJURY IN ASSOCIATION WITH THIS EVENT. REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE IFU. THE CATHETER WAS FLUSHED AS INDICATED IN THE IFU. THERE WERE NOT ANY PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. THE PHYSICIAN CUT THE TIPS OFF OF THE CATHETERS AND IS PREPARED TO SEND BACK ALONG WITH SOLITAIRE. 9F CELLO BALLOON GUIDE CATHETER, SOLITAIRE 6X40, MARKSMAN 160. FA-55160-1030. LOT UNKNOWN AS MENTIONED IN MY REPORT THE DOCTOR CUT THE TIPS OF ALL CATHETERS USED IN THE PROCEDURE AND SENT THEM. THE TIP DID NOT DETACH IN THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8315320 ↗
• MalfunctionJan 25, 2019Break; Break

  MEDTRONIC RECEIVED REPORT THAT AFTER THE SECOND PASS, THE REACT 68 CATHETER WAS NOTED TO HAVE FALLEN APART. THE CATHETER WAS REPORTED TO HAVE FELT STICKY WITH THE VELOCITY MICROCATHETER. RESISTANCE WAS FELT WHEN NAVIGATING WITH THE REACT AND WHEN IT WAS USED WITH THE GUIDEWIRE. DURING THE 1ST PASS, THERE WAS SOME DIFFICULTY PULLING THE VELOCITY MICROCATHETER OUT OF THE REACT WHILE THE STENT WAS DEPLOYED (MORE THAN USUAL). ON THE SECOND PASS, PULLED THE SOLITAIRE 4X40 STENT AND REACT TOGETHER. THE DISTAL SECTION OF THE REACT WAS NOTED TO HAVE FELL APART. HOWEVER, WERE ABLE TO REMOVED THE PORTION OF THE CATHETER THAT SHEARED OFF. THIS EVENT OCCURRED DURING AN OCCLUSION IN THE POSTERIOR. A CONTINUOUS FLUSH WAS USED AND ALL THE CATHETERS WERE FLUSHED. THERE WAS NO ALLEGATION THAT THE DEVICE WERE NOTED TO HAVE BEEN DAMAGED PRIOR TO THEIR USE. THE REACT AND THE SEPARATED TIP WILL BE RETURNED FOR ANALYSIS. THE PATIENT ANATOMY WAS STRAIGHTFORWARD WITH MINIMAL TORTUOSITY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8278601 ↗
• MalfunctionJan 4, 2019Break; Break

  MEDTRONIC RECEIVED REPORT OF REACT-068 CATHETER SEPARATION DURING A DEMONSTRATION. A MEDTRONIC EMPLOYEE WAS AT A FACILITY DEMONSTRATING USE OF THE SOLITAIRE DEVICE AND REACT-068 FOR EDUCATIONAL PURPOSES. THE MEDTRONIC EMPLOYEE REPORTED TYING AND UNTYING A KNOT IN THE 'GREY AREA' OF THE REACT. AS THE REACT WAS BEING MOVED TO THE DEMONSTRATION TABLE, THE CATHETER REPORTEDLY "SNAPPED UNDER ITS OWN WEIGHT" IN THE GREEN AREA CLOSE TO ITS PROXIMAL END. THERE WERE NO PATIENTS INVOLVED IN THIS EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 8217572 ↗
• MalfunctionDec 28, 2018Packaging Problem; Packaging Problem

  MEDTRONIC RECEIVED REPORT THAT WHEN THE REACT CATHETER WAS REMOVED FROM THE HOOP IT WAS NOTICED THAT THE CATHETER WAS FRACTURED AT ABOUT THE MID POINT. THE TECH WAS CERTAIN THAT CATHETER WAS NOT DAMAGED DURING HANDLING BY LAB STAFF IN PREPARATION FOR THE CASE. THERE WAS NO ALLEGATION OF DAMAGING TO THE INNER OR OUTER PACKAGE OF THE DEVICE. NO PATIENT INJURY OCCURRED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8202861 ↗
• DeathNov 14, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED REPORT OF A VESSEL PERFORATION DURING USE OF A REACT CATHETER. THE PATIENT WAS UNDERGOING TREATMENT FOR AN OCCLUSION IN THE M2 MIDDLE CEREBRAL ARTERY (MCA). DURING THE PROCEDURE, THE LEFT INTERNAL WAS ACCESSED USING A NON-MEDTRONIC GUIDEWIRE. AFTERWARD, THE REACT CATHETER WAS DELIVERED WI TH A NON-MEDTRONIC MICROCATHETER INSIDE. A FIRST PASS WAS PERFORMED WITHOUT ISSUE, WHICH ASPIRATED ABOUT 50% OF THE CLOT. A SECOND PASS WAS ATTEMPTED. WHEN DELIVERING THE REACT CATHETER A SECOND TIME, THE CATHETER BECAME "HUNG UP" ON THE POSTERIOR COMMUNICATING (PCOM) ARTERY, BUT THE PHYSICIAN PUSHED PAST THE PCOM ARTERY. WHEN A RUN WAS PERFORMED, "RUPTURE" OF THE PCOM ARTERY WAS OBSERVED. IT WAS ALLEGED THAT THE REACT CATHETER RUPTURED THE PCOM. THE PATIENT REPORTEDLY PASSED AWAY INTRAPROCEDURALLY.

  Patient problems: Death; Great Vessel Perforation

  MAUDE report 8071856 ↗