RebarTM 105-5081-153Recalls & reported problems

Summary

The FDA's MAUDE database contains 102 adverse event reports that list this exact device (DI 00847536026834), received between Dec 4, 2018 and Feb 3, 2026 — classified as 2 deaths, 4 injuries, 96 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (84 reports).

2 other recalls cover devices cleared under the same FDA submission (K001966, K093750); they may or may not involve this specific model.

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 25 most recent of 102 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 3, 2026Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE SOLITAIRE AB ENCOUNTERED RESISTANCE AND THE TIP BECAME DAMAGED DURING THE PROCEDURE. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM IN THE LEFT INTERNAL CAROTID ARTERY C6 SEGMENT. IT WAS NOTED THE PATIENT¿S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MODERATE. THE STROKE ONSET TO REPERFUSION WAS APPROXIMATELY THREE HOURS. IT WAS REPORTED THAT THERE WAS RESISTANCE WHEN ADVANCING THE DISTAL END OF THE SOLITAIRE AB STENT. AFTER SEVERAL ATTEMPTS AND WITHDRAWAL, IT WAS FOUND THAT THE TIP OF THE STENT WAS ¿ROUGH.¿ THE RESISTANCE WAS FELT DURING DELIVERY IN THE PROCEDURE. THE DISTAL SECTION OF THE CATHETER EXPERIENCED RESISTANCE. THE VESSEL WAS TORTUOUS. THE DEVICE AND ANY ACCESSORIES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE CAUSE OF THE EVENT WAS NOT DETERMINED. A CONTINUOUS SALINE FLUSH WAS ADMINISTERED AND MAINTAINED AS INDICATED IN THE IFU. THE CATHETER WAS A MEDTRONIC PRODUCT. ADDITIONAL INFORMATION WAS RECEIVED. THERE WAS NO KINK OR DAMAGE OBSERVED ON THE CAT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24246999 ↗
• MalfunctionDec 9, 2025Retraction Problem; Physical Resistance/Sticking; Retraction Problem; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT SIGNIFICANT RESISTANCE AND STUCK WERE ENCOUNTERED WHILE ADVANCING THE SOLITAIRE STENT THROUGH THE MICROCATHETER. THE PATIENT WAS UNDERGOING SURGERY FOR ISCHEMIC STROKE THROMBUS REMOVAL LOCATED IN THE LEFT INTERNAL CAROTID ARTERY OPHTHALMIC SEGMENT. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS XXX AND VESSEL TORTUOSITY WAS SEVERE. THE ACCESS VESSEL WAS THE FEMORAL ARTERY. THE PATIENT'S BASELINE MODIFIED RANKIN SCALE (MRS) SCORE WAS 4, POST PROCEDURE SCORE WAS 1. BASELINE NATIONAL INSTITUTES OF HEALTH STROKE SCALE (NIHSS) SCORE WAS 15, POST PROCEDURE SCORE WAS 4. BASELINE TICI SCORE WAS 0, POST PROCEDURE SCORE WAS 2B. IV TISSUE PLASMINOGEN ACTIVATOR (TPA) WAS NOT CONTRAINDICATED. THERE WERE 0 PASSES WITH THE DEVICE. STROKE ONSET TO REPERFUSION TIME WAS 5 HOURS. IT WAS REPORTED THAT THE SURGEON PLANNED TO USE THE SAB-6-30 FOR THROMBECTOMY. THE LESION WAS LOCATED IN THE OPHTHALMIC SEGMENT OF THE LEFT INTERNAL CAROTID ARTERY. AFTER THE MICRO-GUIDEWIRE GUIDED THE MICROCATHETER IN PLACE, THE MICRO-GUIDEWIRE WAS WITHDRAWN, AND THE SAB-6-30 STENT WAS DELIVERED. SIGNIFICANT RESISTANCE WAS ENCOUNTERED WHEN THE STENT WAS HALFWAY DELIVERED, WHICH THE SURGEON ATTRIB

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23764592 ↗
• MalfunctionNov 25, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE CAUSE OF THE RESISTANCE WAS NOT DETERMINED. IT IS UNCLEAR WHERE IN THE CATHETER THE RESISTANCE OCCURRED. HOWEVER, A CONTINUOUS SALINE FLUSH WAS ADMINISTERED AND MAINTAINED AS INDICATED IN THE IFU.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23646079 ↗
• MalfunctionNov 24, 2025Retraction Problem; Physical Resistance/Sticking; Retraction Problem; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE SURGEON PLANNED TO USE A SOLITAIRE STENT FOR THROMBECTOMY. AFTER THE REBAR MICROCATHETER WAS IN PLACE, A 4-20 STENT WAS DELIVERED. HOWEVER, SIGNIFICANT RESISTANCE WAS ENCOUNTERED WHEN THE STENT REACHED THE MIDDLE OF THE MICROCATHETER, MAKING IT IMPOSSIBLE TO ADVANCE. RETRACTION OF THE STENT ALSO ENCOUNTERED RESISTANCE. TO ENSURE SAFETY, THE SURGEON REMOVED THE STENT AND MICROCATHETER AS A WHOLE. A GUIDEWIRE WAS ALSO FELT TO BE STUCK THROUGH THE MICROCATHETER, SUGGESTING POTENTIAL INTERNAL DAMAGE OF THE MICROCATHETER. A NEW MICROCATHETER WAS THEN USED INSTEAD TO COMPLETE 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 THROMBUS REMOVAL. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MINIMAL. ACCESS VESSEL WAS THE FEMORAL ARTERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23631354 ↗
• MalfunctionNov 17, 2025Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE PATIENT WAS UNDERGOING TREATMENT FOR AN ISCHEMIC STROKE, ACUTE EMBOLISM OF THE END OF THE RIGHT INTERNAL CAROTID ARTERY. IT WAS NOTED THAT THE PATIENT'S BLOOD FLOW WAS XXX AND VESSEL TORTUOSITY WAS SEVERE. THE PATIENT HAD A BASELINE MODIFIED RANKIN SCALE (MRS) SCORE OF 4 AND A NIH STROKE SCALE (NIHSS) SCORE OF14. PRIOR TO THE PROCEDURE, THE THROMBOLYSIS IN CEREBRAL INFARCTION (TICI) SCORE WAS GRADE 1. DURING THE PROCEDURE, THE MRS IMPROVED TO 2, AND THE NIHSS SCORE DECREASED TO 2 POST-PROCEDURES. THE TICI SCORE POST-PROCEDURE WAS GRADE 3, INDICATING SUCCESSFUL REPERFUSION. INTRAVENOUS TPA WAS NOT CONTRAINDICATED. THE DEVICE WAS PASSED ONE TIME DURING THE PROCEDURE. THE STROKE ONSET TO REPERFUSION TIME WAS 2.5 HOURS. IT WAS REPORTED THAT DURING THROMBECTOMY WITH A STENT, THE OPERATOR ENCOUNTERED DIFFICULTIES IN DELIVERING THE SFR STENT DUE TO THE PATIENT'S TORTUOUS BLOOD VESSEL AND SIGNIFICANT RESISTANCE AT THE DISTAL SECTION OF THE REBAR DURING DELIVERING THE STENT. DESPITE SEVERAL ATTEMPTS, THE OPERATOR WAS UNABLE TO PUSH THE STENT OUT OF THE MICROCATHETER (REBAR18). AFTER REMOVAL OF THE STENT, THE STENT DELIVERY GUIDEWIRE WAS FOUND TO BE KINKE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23575604 ↗
• MalfunctionNov 5, 2025Leak/Splash; Leak/Splash

  ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE LESION WAS A LEFT MIDDLE CEREBRAL ARTERY M1. THE TORN CATHETER WAS NOT USED IN THE PATIENT. NO FRICTION OR RESISTANCE WAS ENCOUNTERED. RESISTANCE WAS IN THE DISTAL SECTION. A ZHONGTIAN DISTAL ACCESS CATHETER WAS USED. THE CATHETER WAS FLUSHED PER IFU DURING THE PROCEDURE. THE CAUSE OF THE TEAR/LEAK WAS NOT DETERMINED. NO DAMAGE OR EVIDENCE OF TAMPERING TO DEVICE PACKAGING. THE DEVICE PACKAGING WAS NOT DAMAGED ON DELIVERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23480376 ↗
• MalfunctionOct 21, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE REBAR CATHETER MET RESISTANCE. IT WAS REPORTED THAT DURING A NEUROINTERVENTIONAL PROCEDURE ON A PATIENT, THE REBAR MICROCATHETER EXPERIENCED JAMMING AND COULD NOT BE USED NORMALLY. IT WAS IMMEDIATELY REPLACED WITH A NEW ONE. THE DEVICE AFFECTED THE DURATION OF THE SURGERY. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). PROLONGED SURGERY WAS CAUSED BY THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE CAUSE OF THE EVENT WAS NOT DETERMINED. THE LESION WAS A RIGHT MIDDLE CEREBRAL ARTERY M1 SEGMENT OCCLUSION. THE EVENT OCCURRED DURING SURGERY AND THE BLOOD VESSEL WAS SEVERELY BENT. THE PROCEDURE WAS AN ACUTE ISCHEMIC STROKE, STENT THROMBECTOMY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23348775 ↗
• MalfunctionSep 18, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT A SOLITAIRE STENT MET RESISTANCE IN THE PROXIMAL END OF A REBAR CATHETER AND THE STENT WAS NOT MOVING FORWARD. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A MIDDLE CEREBRAL ARTERY (MCA) OCCLUSION STROKE. MCA VESSEL DIAMETER WAS 2.5 MM. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED, AND THE CATHETER WAS FLUSHED, AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23087559 ↗
• MalfunctionSep 12, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT DURING DELIVERY OF THE SOLITAIRE FR THROMBECTOMY STENT, THE STENT COULD NOT PASS THROUGH THE MIDDLE OF THE REBAR CATHETER. ATTEMPTS WERE MADE TO RETRIEVE IT, HOWEVER, IT STILL FAILED TO PASS THROUGH. THE ENTIRE STENT SYSTEM AND CATHETER WERE REPLACED TO COMPLETE THE PROCEDURE. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT. THE PATIENT WAS UNDERGOING A THROMBECTOMY SURGERY FOR TREATMENT OF A ISCHEMIC STROKE IN THE INTERNAL CAROTID ARTERY. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. FEMORAL ARTERY ACCESS VESSEL DIAMETER WAS 7 MM. INTRAVENOUS TISSUE PLASMINOGEN ACTIVATOR (IV TPA) WAS NOT CONTRAINDICATED IN THIS CASE. THE PROCEDURE INVOLVED ONE PASS WITH THE DEVICE. THE PATIENT'S BASELINE AND POST-THROMBECTOMY CONDITION (TICI, NIHSS ETC.) AND STROKE ONSET TO REPERFUSION TIME WAS UNKNOWN. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED, AND THE CATHETER WAS FLUSHED, AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23038935 ↗
• MalfunctionSep 11, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT AFTER THE STENT WAS REMOVED AND HYDRATED, THERE WAS A LARGE RESISTANCE WHEN PUSHING THE CATHETER. WHEN THE STENT WAS PUSHED OUT OF THE CATHETER, IT WAS OBSERVED THAT IT WAS KINKED NEAR THE DEPLOYMENT POINT. CONCERNED THAT IT WOULD AFFECT THE DELIVERY OF THE STENT, IT WAS REPLACED WITH A NEW STENT AND THE OPERATION CONTINUED. ADDITIONAL INFORMATION WAS RECEIVED. THE CAUSE OF THE RESISTANCE AND KINK WAS NOT DETERMINED. RESISTANCE OCCURRED IN THE PROXIMAL SECTION OF THE CATHETER. THE DEVICE AND ANY ACCESSORIES WERE PREPARED AND 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 ISCHEMIC STROKE. THERE WERE 0 PASSES WITH THE DEVICE. IT WAS NOTED THAT THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23031850 ↗
• MalfunctionAug 6, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  ADDITIONAL INFORMATION WAS RECEIVED. THE CAUSE OF THE RESISTANCE WAS NOT DETERMINED. A CONTINUOUS SALINE FLUSH WAS ADMINISTERED AND MAINTAINED AS INDICATED IN THE IFU. NO KINK OR DAMAGE TO THE SOLITAIRE WAS OBSERVED. NO KINK OR DAMAGE TO THE CATHETER WAS OBSERVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22727839 ↗
• MalfunctionJul 23, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE PATIENT WAS UNDERGOING WHOLE BRAIN ANGIOGRAPHY AND THROMBECTOMY OPERATION FOR ISCHEMIC STROKE M2 SEGMENT OCCLUSION TREATMENT. THE SITE OF INTRACRANIAL VASCULAR OCCLUSION WAS DETERMINED BY ANGIOGRAPHY. IT WAS NOTED THAT THE PATIENT¿S VESSEL TORTUOSITY WAS MODERATE. THE STROKE ONSET TO REPERFUSION TIME WAS 40MIN IT WAS REPORTED THAT THE GUIDE SHEATH, NEUROVASCULAR GUIDEWIRE, THROMBUS ASPIRATION CATHETER, REBAR18 MICROCATHETER, AND INTRACRANIAL VASCULAR STENT SAB-6-30 WERE SELECTED. AFTER THE PREPARATION WORK WAS COMPLETED, THE REBAR 18 MICROCATHETER WAS SUCCESSFULLY PUT IN PLACE. THE SURGEON SELECTED THE INTRACRANIAL VASCULAR STENT SAB-6-30 AND MOISTENED IT IN VITRO. DURING THE DELIVERY PROCESS OF SLOWLY PUSHING THE STENT, IT WAS FOUND THAT THE RESISTANCE TO PUSHING THE STENT GRADUALLY INCREASED AT THE PROXIMAL SECTION OF THE CATHETER, AND FINALLY THE STENT COULD NOT BE PUSHED FURTHER. IT WAS FOUND THAT THE TAIL OF THE STENT WAS CLOGGED AT THE TAIL OF THE MICROCATHETER. THE SURGEON TRIED MANY TIMES BUT FAILED TO PUSH IT. TWO NEW REBAR18 MICROCATHETERS WERE USED INSTEAD FOR DELIVERY, BUT THEY COULD NOT BE PUSHED IN PLACE. BECAUSE THE PATIENT WAS AL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22576412 ↗
• MalfunctionJul 23, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT'S BASELINE NIHSS WAS 12 AND POST PROCEDURE TICI NIHSS HAD IMPROVED TO 3. THE CAUSE OF THE RESISTANCE WAS NOT DETERMINED. CONTINUOUS SALINE FLUSH WAS ADMINISTERED AND MAINTAINED DURING THE PROCEDURE PER THE IFU. THERE WAS NOT KINK/DAMAGE OBSERVED TO THE CATHETER(S) AFTER REMOVAL. ALL THE ATTEMPTED REBAR 18 MICROCATHETERS WERE FROM THE SAME MODEL/LOT. IT SHOULD BE NOTED THAT PER THE IFU, THE SAB-6-30 IS RECOMMENDED FOR USE WITH A CATHETER THAT HAS AN INNER DIAMETER OF 0.027 INCHES AND IS THEREFORE NOT COMPATIBLE/OFF LABEL USE WITH REBAR 18 CATHETER WHICH HAS AN INNER DIAMETER OF AS IT HAD A LABELED INNER DIAMETER OF 0.021 INCHES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22576386 ↗
• MalfunctionJul 23, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE PATIENT WAS UNDERGOING WHOLE BRAIN ANGIOGRAPHY AND THROMBECTOMY OPERATION FOR ISCHEMIC STROKE M2 SEGMENT OCCLUSION TREATMENT. THE SITE OF INTRACRANIAL VASCULAR OCCLUSION WAS DETERMINED BY ANGIOGRAPHY. IT WAS NOTED THAT THE PATIENT¿S VESSEL TORTUOSITY WAS MODERATE. THE STROKE ONSET TO REPERFUSION TIME WAS 40MIN IT WAS REPORTED THAT THE GUIDE SHEATH, NEUROVASCULAR GUIDEWIRE, THROMBUS ASPIRATION CATHETER, REBAR18 MICROCATHETER, AND INTRACRANIAL VASCULAR STENT SAB-6-30 WERE SELECTED. AFTER THE PREPARATION WORK WAS COMPLETED, THE REBAR 18 MICROCATHETER WAS SUCCESSFULLY PUT IN PLACE. THE SURGEON SELECTED THE INTRACRANIAL VASCULAR STENT SAB-6-30 AND MOISTENED IT IN VITRO. DURING THE DELIVERY PROCESS OF SLOWLY PUSHING THE STENT, IT WAS FOUND THAT THE RESISTANCE TO PUSHING THE STENT GRADUALLY INCREASED AT THE PROXIMAL SECTION OF THE CATHETER, AND FINALLY THE STENT COULD NOT BE PUSHED FURTHER. IT WAS FOUND THAT THE TAIL OF THE STENT WAS CLOGGED AT THE TAIL OF THE MICROCATHETER. THE SURGEON TRIED MANY TIMES BUT FAILED TO PUSH IT. TWO NEW REBAR18 MICROCATHETERS WERE USED INSTEAD FOR DELIVERY, BUT THEY COULD NOT BE PUSHED IN PLACE. BECAUSE THE PATIENT WAS AL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22576380 ↗
• MalfunctionJul 18, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED REPORTED THERE WAS NO KINK/DAMAGE OBSERVED TO THE CATHETER AFTER REMOVAL. SOLITAIRE WAS NOT USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22542600 ↗
• MalfunctionJul 17, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED REPORTED THE ANEURYSM DIAMETER WAS 4MM. THE RESISTANCE WAS IN THE MIDDLE OF THE CATHETER. THERE WAS NO DAMAGE OBSERVED TO THE CATHETER OR STENT AFTER REMOVAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22532176 ↗
• MalfunctionJul 17, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT WAS UNDERGOING THROMBECTOMY TO TREAT AN INTERNAL CAROTID ARTERY (ICA) OCCLUSION. PATIENT'S VESSEL TORTUOSITY WAS MODERATE. THE DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE RESISTANCE OCCURRED IN THE MIDDLE SEGMENT OF THE REBAR CATHETER. IT WAS NOTED THAT CONTINUOUS SALINE FLUSH WAS ADMINISTERED AND MAINTAINED PER IFU. THERE WAS NO KINK OF OTHER DAMAGE OBSERVED TO THE CATHETER OR SOLITAIRE. THE TIP OF THE SOLITAIRE SHEATH WAS SECURED IN THE HUB OF THE MICROCATHETER. THE CAUSE OF THE RESISTANCE WAS NOT DETERMINED. THE PATIENT DID NOT HAVE ANY SYMPTOMS COMPLICATIONS ASSOCIATED WITH THIS EVENT. THE PATIENT WAS DISCHARGED AND EXPERIENCING NORMAL RECOVERY. STROKE ONSET TO REPERFUSION TIME WAS 8 HOURS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22531867 ↗
• DeathJul 16, 2025Adverse Event Without Identified Device or Use Problem; Physical Resistance/Sticking; Adverse Event Without Identified Device or Use Problem; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED REPORTED THE INDEX PROCEDURE WAS MORE THAN 24 HOURS AFTER THE STROKE BEGAN. THE PATIENT WAS UNCONSCIOUS WHEN BROUGHT TO THE HOSPITAL. THE CLOT WAS HARD. PART OF THE CLOT WAS RETRIEVED WITH THE FIRST SOLITAIRE (SFR4-6-40-10) WHICH IS WHEN THE PUSHWIRE BROKE. THERE WAS NO DAMAGE TO THE MICROCATHETER. THE SOLITAIRE SFR4-6-40-10 WHICH HAS BROKEN WAS SUCCESSFULLY RETRIEVED WITH THE SOLITAIRE X (SFR4-4-40-10). AFTER THAT, THE PHYSICIAN ATTEMPTED ASPIRATION OF THE REMAINING CLOT USING A NON-MEDTRONIC SYSTEM. DESPITE THESE INTERVENTIONS, COMPLETE REVASCULARIZATION WAS NOT ACHIEVED. ANCILLARY DEVICES: PENUMBRA ASPIRATION SYSTEM.

  Patient problems: Ischemia Stroke; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22521504 ↗
• MalfunctionJul 14, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE SURGEON USED THIS PRODUCT IN EMERGENCY INTRACRANIAL ARTERY THROMBECTOMY SURGERY. AFTER OPENING THE PACKAGE AND VENTING AND HYDRATING NORMALLY, THE REBAR-18 MICROCATHETER WAS PUSHED IN. DURING THE INSERTION OF THE STENT, THERE WAS AN OBVIOUS OBSTRUCTION WHEN IT ENTERED THE MICROCATHETER, AND THE STENT COULD NOT BE PUSHED FORWARD ANY FURTHER. THE STENT WAS THEN REMOVED AND THE MICROCATHETER WAS CHECKED. THE MICROCATHETER WAS NORMAL, BUT THE TAIL END OF THE STENT WAS KINKED AND COULD NOT BE USED NORMALLY. THE STENT WAS THEN REPLACED WITH A NEW PRODUCT OF THE SAME MODEL, WHICH DID NOT CAUSE ANY ADVERSE EFFECTS ON THE PATIENT. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22499302 ↗
• MalfunctionJul 14, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE PATIENT WAS TREATED IN THE OPERATING ROOM FOR CEREBRAL ARTERY INFARCTION. AT 9:30 AM ON (B)(6) 2025, DURING THE PERCUTANEOUS INTRACRANIAL ARTERY EMBOLECTOMY, THE EV3REBAR-18 MICROCATHETER COULD NOT PASS THROUGH THE STENT, AFFECTING THE NORMAL OPERATION. THE MICROCATHETER OF ANOTHER BRAND WAS IMMEDIATELY REPLACED TO CONTINUE THE OPERATION, WHICH HAD NO ADVERSE EFFECTS ON THE PATIENT. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22495488 ↗
• MalfunctionJul 10, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED REPORTED STROKE ONSET TO REPERFUSION TIME: 5 HOURS. THE PROCEDURE WAS COMPLETED BY REPLACING THE STENT WITH A SMALLER DIAMETER 4-20. CONTINUOUS SALINE FLUSH WAS ADMINISTERED AND MAINTAINED AS INDICATED IN THE IFU. THERE WAS N DAMAGE TO THE CATHETER OR SOLITAIRE PUSHWIRE. THE TIP OF THE SOLITAIRE SHEATH WAS SECURED INTO THE HUB OF THE MICROCATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22469266 ↗
• MalfunctionJul 7, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING A MECHANICAL THROMBECTOMY PROCEDURE TO TREAT AN ISCHEMIC STROKE IN THE M1 SEGMENT OF THE LEFT BRAIN, THE SOLITAIRE FR 6X30 STENT COULD NOT BE PUSHED OUT OF THE REBAR 18 MICROCATHETER AT THE DISTAL END. REPEATED ADJUSTMENTS TO DELIVER THE STENT WERE UNSUCCESSFUL. THE STENT WAS REPLACED WITH ANOTHER STENT TO COMPLETE THE PROCEDURE. STENT DAMAGE WAS OBSERVED AT THE CONNECTION BETWEEN THE STENT BODY AND THE DELIVERY ROD, AND THIS WAS NOTED OUT OF THE PACKAGE. THE PATIENT'S BASELINE MRS, NIHSS, AND TICI SCORES WERE 4, 13, AND 1 RESPECTIVELY. POST-PROCEDURE THESE WERE 4, 13, AND 2B RESPECTIVELY. IV TPA WAS NOT CONTRAINDICATED. THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. THE STROKE ONSET TO REPERFUSION TIME WAS 7 HOURS. NO PATIENT COMPLICATIONS OR SYMPTOMS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22425313 ↗
• MalfunctionJul 7, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE PATIENT WAS UNDERGOING TREATMENT FOR AN ISCHEMIC STROKE; ACUTE LARGE ARTERY OCCLUSION LOCATED AT LEFT INTERNAL CAROTID ARTERY. IT WAS NOTED THAT THE PATIENT'S VESSEL TORTUOSITY WAS NORMAL. THE IV TPA WAS NOT CONTRAINDICATED. NO    IT WAS REPORTED THAT THE SURGEON USED AN SFR STENT FOR THROMBECTOMY. DURING DELIVERY, AFTER THE STENT ENTERED THE MICROCATHETER, IT COULD NOT BE PUSHED FORWARD AND ENCOUNTERED RESISTANCE IN THE MIDDLE SECTION OF THE REBAR CATHETER . THE VESSEL WAS NOT TORTUOUS. AFTER THE SURGEON REPLACED THE STENT AND THE CATHETER, THE PROCEDURE WAS SUCCESSFULLY COMPLETED AND THE PATIENT WAS NOT INJURED. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AND FLUSHED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22423488 ↗
• MalfunctionJun 30, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT DURING THE THROMBECTOMY, THE SOLITAIREAB STENT ENCOUNTERED RESISTANCE WHEN ENTERING THE REBAR18 MIC ROCATHETER. THE RESISTANCE WAS LOCATED IN THE MIDDLE AND PROXIMAL SECTION OF THE MICROCATHETER. THE STENT WAS ABLE TO PASS THROUGH THE GUIDE SHEATH SMOOTHLY, AND THE STENT WAS REPLACED TO COMPLETE THE SURGERY. DURING THE PERIOD, PHYSIOLOGICAL SALINE PRE-FLUSHING AND MAINTENANCE WERE PERFORMED IN ACCORDANCE WITH IFU REQUIREMENTS. THE RESISTANCE OCCURRED DURING PREP. THE STENT ABLE TO BE PUSHED OUT OF THE SHEATH. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A LEFT MIDDLE CEREBRAL ARTERY ISCHEMIC STROKE. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS NORMAL. STROKE ONSET TO REPERFUSION TIME WAS 3 HOURS. IV WAS NOT TISSUE PLASMINOGEN ACTIVATOR (TPA) CONTRAINDICATED. THERE WERE 0 PASSES WITH THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22358078 ↗
• MalfunctionJun 26, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT IN THE EARLY MORNING, THE PHYSICIAN USED THIS PRODUCT IN AN EMERGENCY INTRACRANIAL ARTERY THROMBECTOMY. AFTER THE NURSE OPENED THE PACKAGE, VENTED AND HYDRATED NORMALLY, IT WAS PUSHED IN THE REBAR-18 MICROCATHETER (B706717) . DURING THE PUSHING PROCESS OF THE STENT, THE STENT ENCOUNTERED GREAT RESISTANCE WHEN ENTERING THE CONNECTION BETWEEN THE Y VALVE AND THE MICROCATHETER. AFTER THE STENT WAS RETRIEVED INTO THE PIPELINE, IT WAS RE-DELIVERED TO THE 18 MICROCATHETER, BUT SEVERAL ATTEMPTS FAILED. THE ASSISTANT TOOK OUT THE STENT AND REHYDRATED IT, AND FOUND THAT THE REMOVED STENT WAS KINKED. DUE TO THE TIGHT SURGICAL TIME, THE PRODUCT WAS REPLACED FOR USE AND NO ADVERSE EFFECTS WERE CAUSED TO THE PATIENT. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION RECEIVED REPORTED THE STENT WAS RE-ENTERED INTO THE 18 MICRO-CATHETER, BUT IT WAS DIFFICULT TO PUSH THE STENT AND THERE WAS GREAT RESISTANCE. THE STENT WAS SUBSEQUENTLY REMOVED AND RE-ENTERED, BUT THE STENT COULD NOT BE PUSHED FORWARD. THE RESISTANCE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22343065 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K001966, K093750. One submission often covers many models, so check the product and lot details in each record.

• Z-1556-2022 · Jun 30, 2022 · Open, Classified
  Echelon -14, 45 Tip Shape, REF 145-5092150, sterile EO, Rx Only
• Z-1557-2022 · Jun 30, 2022 · Open, Classified
  Echelon -14 Micro Catheter, REF: 105-5092-150, sterile EO, Rx Only