Rebar 105-5081-153 (UDI 00763000539344)Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00763000539344), received between Nov 14, 2025 and Sep 29, 2026 — classified as 1 injury, 11 malfunctions.

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

• MalfunctionSep 29, 2026Physical Resistance/Sticking

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50938713 ↗
• InjurySep 29, 2026Physical Resistance/Sticking

  Medtronic received a report that a Solitaire AB stent was damaged during the procedure and encountered resistance The patient was undergoing surgery for treatment of a M1 ischemic stroke. The mRS baseline and procedure score was 1. The NIHSS baseline and post procedure score was 1. The TICI score baseline and post procedure was 0. IV TPA (intravenous tissue plasminogen activator) was not contraindicated. There were 2 passes with the device. It was noted the patient's vessel tortuosity was normal. Stroke onset to reperfusion time was 2 hours. It was reported that the patient had acute cerebral infarction and underwent thrombectomy in the right middle cerebral artery M1 segment. During the procedure, the SAB-6-30 was used for thrombectomy. During delivery through the middle segment of the Rebar18, the stent became stuck in the microcatheter. After the stent was removed, it was observed that the tail end of the stent had a kink, and the tail end of the stent was severely deformed. After the stent was replaced, the procedure proceeded smoothly. The reported device and any accessory devices were prepared as indicated in the instructions for use (IFU). No patient symptoms or complication

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50936804 ↗
• MalfunctionSep 4, 2026Break; Packaging Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50611458 ↗
• MalfunctionAug 21, 2026Retraction Problem; Material Deformation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50372706 ↗
• MalfunctionJun 9, 2026Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE OPERATOR PLANNED TO TREAT TERMINAL INTERNAL CAROTID ARTERY STENOSIS USING AN SAB-6-20 STENT. AFTER THE STENT DELIVERY MICROCATHETER (REBAR-18) WAS POSITIONED, DIFFICULTY WAS FELT DURING HYDRATION AND DELIVERY OF THE STENT, WITH A VERY ROUGH TACTILE FEEL INTRAOPERATIVELY. MULTIPLE ATTEMPTS WERE UNSUCCESSFUL, AND THE PROCEDURE WAS COMPLETED AFTER USING ANOTHER STENT INSTEAD. RESISTANCE OCCURRED IN THE MIDDLE SECTION OF THE CATHETER. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). NO PATIENT SYMPTOMS OR COMPLICATIONSWERE ASSOCIATED WITH THIS EVENT. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF STENOSIS AT THE TERMINAL SEGMENT OF THE RIGHT INTERNAL CAROTID ARTERY. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. ADDITIONAL INFORMATION RECEIVED REPORTED RESISTANCE OCCURRED AT THE MIDDLE SECTION OF THE CATHETER. THERE WERE NOT ANY DAMAGES ON THE CATHETEROR THE PUSHWIRE OF THE SOLITAIRE, AND THE TIP OF THE SOLITARE WAS SECURED INTO THE HUB OF THE MICRO CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25447979 ↗
• MalfunctionMay 29, 2026Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THERE WAS RESISTANCE DURING DELIVERY OF THE SOLITAIRE WITHIN THE MIDDLE OF THE REBAR-18 CATHETER. IN ADDITION, THE SOLITAIRE STENT WAS FOUND KINKED. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF AN ISCHEMIC STROKE LOCATED IN THE LEFT INTERNAL CAROTID MIDDLE CEREBRAL ARTERY. THE MODIFIED RANKIN SCALE (MRS) SCORE AT BASELINE WAS 4, AND THE MRS SCORE AT THE TIME OF THE PROCEDURE WAS 4. THE NATIONAL INSTITUTES OF HEALTH STROKE SCALE (NIHSS) SCORE AT BASELINE WAS 16, AND 4 POST PROCEDURE. THE THROMBOLYSIS IN CEREBRAL INFARCTION (TICI) SCORE AT BASELINE WAS 0 AND 3 POST PROCEDURE. VASCULAR ACCESS WAS OBTAINED VIA THE FEMORAL ARTERY, WITH AN ACCESS VESSEL DIAMETER OF 10 MM. THE TIME FROM STROKE ONSET TO REPERFUSION WAS 5 HOURS. IT WAS NOTED THAT THE PATIENT¿S VESSEL TORTUOSITY WAS NORMAL. IT WAS REPORTED THAT THE PHYSICIAN WAS PERFORMING A LEFT-SIDED MIDDLE CEREBRAL INFARCTION SURGERY. THE PHYSICIAN CONSIDERED USING A STENT FOR THROMBECTOMY AND SELECTED AN SFR-4-20 STENT. HOWEVER, WHEN ENTERING THE MID-SECTION OF THE REBAR18 MICROCATHETER, SIGNIFICANT RESISTANCE WAS FELT WHEN THE STENT WAS WITHIN THE MICROCATHETER, AND THE STENT BECAME STUCK IN THE M

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25331821 ↗
• MalfunctionApr 17, 2026Retraction Problem; Material Deformation; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT SOLITAIRE STENT COULD NOT PASS THROUGH THE REBAR MICROCATHETER. THE PATIENT WAS UNDERGOING STENT ASSISTED COIL EMBOLIZATION SURGERY FOR TREATMENT OF AN UNRUPTURED, SACCULAR, LEFT INTERNAL CAROTID ARTERY CAVERNOUS SEGMENT ANEURYSM. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS SEVERE. VASCULAR ACCESS WAS OBTAINED VIA THE FEMORAL ARTERY. IT WAS REPORTED THAT AFTER THE STENT MICROCATHETER WAS POSITIONED IN PLACE AND THE COIL DELIVERY MICROCATHETER WAS ADVANCED INTO POSITION, STENT DELIVERY WAS THEN INITIATED, AND WHEN REACHING THE PRE-CURVED SEGMENT OF THE CAVERNOUS SINUS SEGMENT, RESISTANCE WAS VERY LARGE AND THE STENT BECAME STUCK; DURING WITHDRAWAL, THE STENT WAS LODGED WITHIN THE MICROCATHETER AND COULD NOT BE WITHDRAWN, THEREFORE THE STENT AND THE MICROCATHETER WERE REMOVED TOGETHER, RESISTANCE WAS STILL ENCOUNTERED DURING EX VIVO ATTEMPTS, THE OPERATOR SUSPECTED THAT THE STENT AND THE MICROCATHETER HAD ALREADY SUSTAINED DAMAGE, AND THE PROCEDURE WAS COMPLETED AFTER REPLACING WITH A NEW STENT AND A NEW MICROCATHETER. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT. THE REPORTED DEVICE AND ANY ACCES

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24911506 ↗
• MalfunctionFeb 5, 2026Break; Insufficient Device Problem Information

  ADDITIONAL INFORMATION RECEIVED THAT THE ARTISSE DEVICE HAD MOVEMENT UPON DETACHMENT. IT IS NOT BELIEVED THAT THE REBAR CATHETER WAS THE CAUSE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24269280 ↗
• MalfunctionDec 29, 2025Retraction Problem; Physical Resistance/Sticking; Retraction Problem; Physical Resistance/Sticking

  ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE CAUSE OF THE RESISTANCE/STUCK WAS NOT DETERMINED. RESISTANCE WAS ENCOUNTERED IN THE DISTAL SECTION OF THE CATHETER. A CONTINUOUS SALINE FLUSH WAS ADMINISTERED AND MAINTAINED AS INDICATED IN THE IFU.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23909091 ↗
• MalfunctionDec 9, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE CAUSE OF THE EVENT WAS SUSPECTED THAT THE STENT DETACHMENT SYRINGE NEEDLE DID NOT PENETRATE THE MUSCLE LAYER, OR THAT THE STENT DETACHMENT POINT WAS POSITIONED AGAINST THE BLOOD VESSEL WALL. THERE WAS RESISTANCE AT THE DISTAL END OF THE STENT, AND THE STENT DID NOT ADVANCE WHEN THE OPERATOR PUSHED THE STENT GUIDEWIRE. THERE WAS A CONTINUOUS INFUSION OF SALINE SOLUTION THROUGH THE MICROCATHETER.

  Patient problems: Obstruction/Occlusion; Thrombosis/Thrombus

  MAUDE report 23764544 ↗
• MalfunctionNov 19, 2025Retraction Problem; Physical Resistance/Sticking; Retraction Problem; Physical Resistance/Sticking

  ADDITIONAL INFORMATION WAS RECEIVED. NO DAMAGE WAS OBSERVED TO THE STENT, AND THE CAUSE OF THE RESISTANCE WAS NOT DETERMINED. THE PATIENT¿S BASELINE WAS TICI LEVEL 1 WITH AN NIHSS SCORE OF 15, AND POST-THROMBECTOMY, THE PATIENT¿S CONDITION IMPROVED TO TICI LEVEL 2B WITH AN NIHSS SCORE OF 4. NO KINK OR DAMAGE WAS FOUND ON THE CATHETER OR THE SOLITAIRE PUSHWIRE, AND THE TIP OF THE SOLITAIRE SHEATH WAS SECURED INTO THE HUB OF THE MICROCATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23595216 ↗
• MalfunctionNov 14, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE SOLITAIRE EXPERIENCED RESISTANCE IN THE DISTAL SECTION OF THE CATHETER. THE PATIENT WAS UNDERGOING TREATMENT FOR AN ISCHEMIC STROKE IN THE MIDDLE CEREBRAL ARTERY M1. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. THE MRS AT BASELINE WAS 4 AND 1 AT PROCEDURE. NIHSS WAS 15 AT BASELINE AND 2 POST PROCEDURE. TICI WAS 0 AT BASELINE AND 3 POST PROCEDURE. IV TPA WAS NOT CONTRAINDICATED. THERE WERE 2 PASSES WITH THE SOLITAIRE DEVICE. STROKE ONSET TO REPERFUSION TIME WAS 4 HOURS. IT WAS REPORTED THAT THE SURGEON DETERMINED THAT THE AMOUNT OF THROMBUS WAS LARGE AFTER ANGIOGRAPHIC SCREENING, AND PLANNED TO USE SWIM FOR THROMBUS EXTRACTION AND THROMBECTOMY. THE SOLITAIRE WAS SELECTED FOR THROMBECTOMY. AFTER THE ASPIRATION CATHETER 71 WAS IN PLACE, THE STENT WAS DELIVERED USING REBAR18. WHEN THE STENT WAS HALFWAY DELIVERED, THE RESISTANCE INCREASED AND IT WAS PUSHED UPWARDS TO THE INTRACRANIAL ARTERY. SEEING THAT THERE WAS STILL SOME DISTANCE TO THE LESION,THE SURGEON WITHDREW IT, FLUSHED IT, HYDRATED IT, AND DELIVERED IT AGAIN. THE RESULT WAS SIMILAR TO THE FIRST TIME. THE SURGEON PUSHED THE STENT HARD INTO THE LESION, BUT THERE WAS RESISTANCE D

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23554359 ↗