RebarTM 105-5082-145Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00847536026896), received between Apr 7, 2022 and Aug 18, 2025 — classified as 2 injuries, 15 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (13 reports).

2 other recalls cover devices cleared under the same FDA submission (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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 18, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  ADDITIONAL INFORMATION WAS RECEIVED. THE LESION WAS AN ANTERIOR CEREBRAL ARTERY OCCLUSION WITH MODERATE VESSEL TORTUOSITY. THE CAUSE OF THE RESISTANCE AND KINK WAS UNKNOWN. THE PATIENT¿S BASELINE (TICI, NIHSS, ETC.) AND POST-THROMBECTOMY CONDITION WERE ALSO UNKNOWN. RESISTANCE OCCURRED 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 22832066 ↗
• MalfunctionJun 9, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT DURING DELIVERY, A SOLITAIRE FR ENCOUNTERED RESISTANCE IN THE SHEATH OF THE CATHETER. AFTER POSITIONING THE MICROCATHETER (105-5082-145), THE STENT (SFR-6-30) WAS HYDRATED AND PREPARED FOR DELIVERY. HOWEVER, IT WAS FOUND THAT THE STENT COULD NOT ENTER THE TIP OF THE MICROCATHETER. MULTIPLE ATTEMPTS WERE UNSUCCESSFUL, AND THE STENT WAS EVENTUALLY REPLACED WITH ANOTHER BRAND, ALLOWING THE SURGERY TO BE SUCCESSFULLY COMPLETED. 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. THE PATIENT WAS UNDERGOING SURGERY FOR ISCHEMIC STROKE IN THE MIDDLE CEREBRAL ARTERY OCCLUSION. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. IV TPA WAS NOT CONTRAINDICATED. THERE WAS 1 PASS WITH THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22169973 ↗
• MalfunctionMay 12, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED INFORMATION REGARDING A SOLITAIRE FR STENT RETRIEVER THAT HAD RESISTANCE DURING DELIVERY IN THE REBAR MICROCATHETER. THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE TO TREAT ISCHEMIC STROKE VIA FEMORAL ACCESS. THE ACCESS VESSEL DIAMETER WAS 20MM. VESSEL TORTUOSITY WAS MODERATE.  IT WAS REPORTED THAT THE DEVICES WERE PREPARED AND CATHETER FLUSHED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE SOLITAIRE COULD NOT BE DELIVERED DUE TO RESISTANCE IN THE DISTAL END OF THE REBAR MICROCATHETER. IT WAS NOTED THAT THE DISTAL END OF THE CATHETER WAS BENT. THE VESSEL WAS NOTED TO BE TORTUOUS AND TORTUOSITY WAS SPECIFIED AS "MODERATE." TWO PASSES WERE MADE WITH THE DEVICE. BOTH THE CATHETER AND SOLITAIRE WERE REMOVED AND REPLACED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WAS NO HARM OR INJURY TO THE PATIENT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22005866 ↗
• MalfunctionMay 12, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THERE WAS SIGNIFICANT RESISTANCE WHILE ATTEMPTING TO ADVANCE, AND UPON WITHDRAWAL FOR INSPECTION, IT WAS FOUND THAT THE PUSH ROD WAS BENT. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE DEVICE AND ANY ACCESSORIES WERE PREPARED AS INDICATED IN THE IFU. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF ISCHEMIC STROKE LOCATED IN THE MIDDLE CEREBRAL ARTERY (MCA). THERE WAS ONE PASS WITH THE DEVICE. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. STROKE ONSET TO REPERFUSION TIME WAS 5 HOURS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22002130 ↗
• MalfunctionApr 30, 2025Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT AN AXIUM COIL ENCOUNTERED RESISTANCE WITH THE REBAR CATHETER AND WAS FOUND TO NO BE ABLE TO DETACH. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A NEUROVASCULAR ABNORMALITY GRADE 2 IN THE RIGHT ANTERIOR COMMUNICATING ARTERY. THE ABNORMALITY WAS NOT LOCATED IN THE ELOQUENT REGION. THE ACCESSED VESSEL WAS THE RADIAL ARTERY MEASURING A DIAMETER OF 3 MM. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MODERATE. THE PATIENT'S PAST MEDICAL HISTORY INCLUDES HYPERTENSION. IT WAS REPORTED THAT WHEN DOING CORONARY FISTULA EMBOLIZATION SURGERY, FIRSTLY OPENED THE MICROCATHETER AND MICROGUIDEWIRE, AND THE 45° ECHELON MICROCATHETER WAS ADVANCED TO THE LESION POSITION THROUGH THE GUIDE CATHETER. PREPARED TO PUSH THE DETACHABLE SPRING COIL QC-2-4-3D (227135720) FROM THE MICROCATHETER. THE SPRING COIL COULD NOT BE PUSHED OUT OF THE SPRING COIL PROTECTION TUBE. THE RESISTANCE WAS VERY LARGE. AFTER REPEATED PUSHING, IT STILL COULD NOT BE PUSHED OUT. THEN REPLACED IT WITH THE QC-1.5-2-HELIX (226607278), IT SUCCESSFULLY DETACHED FOR THE EMBOLIZATION. IT WAS REPORTED DURING THE OPERATION, WHEN THE MICROCATHETER WAS OPENED AND FLUSHED WI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21940466 ↗
• MalfunctionApr 18, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE CAUSE OF THE RESISTANCE AND STENT DEFORMITY WAS NOT DETERMINED. CATHETER RESISTANCE OCCURRED IN THE MIDDLE SEGMENT. A CONTINUOUS SALINE FLUSH WAS ADMINISTERED AND MAINTAINED AS INDICATED IN THE IFU.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21866286 ↗
• MalfunctionMar 27, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT A SOLITAIRE FR ENCOUNTERED RESISTANCE DURING PREPARATION IN THE MIDDLE SECTION OF THE REBAR CATHETER. IT WAS REPORTED THAT THE SOLITAIRE FR COULD NOT PASS THROUGH THE REBAR MICROCATHETER. AFTER REPEATED ATTEMPTS WITHOUT SUCCESS, IT WAS REPLACED WITH A NEW SFR OF THE SAME MODEL AND SUCCESSFULLY PASSED THROUGH TO THE LESION. THE STENT WAS ABLE TO BE PUSHED OUT OF THE SHEATH. 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. ANCILLARY DEVICES INCLUDE A REBAR 27 MICROCATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21707274 ↗
• MalfunctionMar 24, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE CAUSE OF THE RESISTANCE WAS NOT DETERMINED. A CONTINUOUS SALINE FLUSH WAS ADMINIST ERED AND MAINTAINED AS INDICATED IN THE IFU.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21677775 ↗
• MalfunctionMar 24, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE CAUSE OF THE RESISTANCE WAS NOT DETERMINED. A CONTINUOUS SALINE FLUSH WAS ADMINISTERED AND MAINTAINED AS INDICATED IN THE IFU.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21677766 ↗
• MalfunctionMar 10, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED REPORTED THE THE RESISTANCE WAS IN THE PROXIMAL SECTION OF THE CATHETER. CONTINUOUS SALINE FLUSH WAS ADMINISTERED AND MAINTAINED AS INDICATED IN THE INSTRUCTIOSN FOR USE (IFU). THERE WAS NO DAMAGED OBSERVED TO THE SOLITAIRE OR REBAR AFTER REMOVAL. THERE WAS NO VASOSPASM OR ATHEROSCLEROSIS IN THE VESSEL PROXIMAL TO THE THROMBECTOMY SITE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21561768 ↗
• MalfunctionJan 24, 2025Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE CAUSE OF THE RESISTANCE AND DAMAGE WAS NOT DETERMINED. THE RESISTANCE WAS IN THE MIDDLE 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 21228298 ↗
• MalfunctionJun 26, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE SOLITAIRE AB AND REBAR CATHETER ENCOUNTERED RESISTANCE AND THE SOLITAIRE AB WAS UNABLE TO DETACH. THE PATIENT WAS UNDERGOING AN ANEURYSM EMBOLIZATION FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM ON THE RIGHT WITH A MAX DIAMETER OF 5.13 MM AND A 4.12 MM NECK DIAMETER. LANDING ZONE: DISTAL: 3.39 MM AND PROXIMAL 4.46 MM. THE ACCESSED VESSEL WAS THE FEMORAL ARTERY. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT WHEN THE PATIENT UNDERWENT STENT-ASSISTED ANEURYSM EMBOLIZATION, THE RESISTANCE OF THE MICROCATHETER WAS TOO LARGE AND THE STENT COULD NOT BE PUSHED, SO IT WAS REPLACED. IT WAS REPORTED THERE WAS CATHETER RESISTANCE IN THE MIDDLE SECTION. IT WAS REPORTED THE STENT COULD NOT BE DETACHED WHEN DEPLOYED AND HAD TO BE REPLACED. NO PATIENT HARM CAUSED. THE PHYSICIAN ATTEMPTED TO DETACH THE STENT WITH THE DETACHMENT BOX 4 TIMES AND EACH ATTEMPT WAS STANDARDIZED TIME OPERATION. THE CONDITION OF THE DETACHMENT BOX WAS BRAND-NEW OUT OF BOX. THE CONDITION OF THE DETACHMENT CABLE WAS BRAND NEW OUT OF BOX. THERE WAS NO DAMAGE TO THE DETACHMENT BOX. THE CATHETER TIP WAS LOCATED THE STANDARD OPE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19617968 ↗
• MalfunctionJan 17, 2024Burst Container or Vessel; Packaging Problem; Burst Container or Vessel; Packaging Problem

  MEDTRONIC RECEIVED A REPORT THAT WHEN THE CUSTOMER WAS USING IT, AFTER OPENING THE PACKAGE, CUSTOMER FOUND THAT THE OPENING OF THE M ICROCATHETER TIP WAS BROKEN AND COULD NOT BE USED. REPLACED WITH ANOTHER PRODUCT OF THE SAME MODEL TO COMPLETE THE OPERATION. IT WAS REPORTED CATHETER RUPTURE (INTACT) OCCURRED IN THE DISTAL SECTION. THERE WAS NO FRICTION OR DIFFICULTY DURING DELIVERY. THERE WAS NO PATIENT INVOLVED IN THIS EVENT. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18528104 ↗
• MalfunctionNov 8, 2023Break; Burst Container or Vessel; Packaging Problem; Break; Burst Container or Vessel; Packaging Problem

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE CATHETER TIP SPLIT WAS ON THE DISTAL SECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18093888 ↗
• InjuryApr 5, 2023Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE STENT WAS STUCK DURING THE PROCEDURE DURING DELIVERY. IT WAS NOTED THAT THE VESSEL WAS MODERATELY TORTUOUS. RESISTANCE OCCURRED IN THE MIDDLE SECTION OF THE CATHETER. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE IFU. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF AN ISCHEMIC STROKE OF THE INTERNAL CAROTID ARTERY, C7. IV TPA WAS NOT CONTRAINDICATED. THERE WERE 2 PASSES WITH THE DEVICE. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MINIMAL. STROKE ONSET TO REPERFUSION TIME WAS 2 HOURS. IT WAS UNKNOWN IF THERE WERE ANY PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION RECEIVED THAT THE PATIENT RECOVERING FROM THE PROCEDURE IS IN A LIGHT COMA. THE PATIENT DID NOT EXPERIENCE ANY SYMPTOMS RELATED TO THE EVENT. THE CATHETER WAS A MEDTRONIC PRODUCT REBAR27 LOT # B412012. THE PATIENT¿S BASELINE NIHSS SCORE 27. THE PATIENT¿S POST-THROMBECTOMY NIHSS SCORE 20.

  Patient problems: Coma

  MAUDE report 16685976 ↗
• InjuryNov 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT A SOLITAIRE FR STENT HAD RESISTANCE IN A REBAR 18 CATHETER AND BROKE. WHEN ANOTHER SOLITAIRE WAS USED THERE WERE COMPLICATIONS. GUIDED BY THE MICRO-GUIDE WIRE WITH A MICRO-CATHETER (REBAR 18), USING COAXIAL TECHNOLOGY, GUIDED THE INTERMEDIATE CATHETER TO THE LOWER END OF THE BASILAR ARTERY, PASSED THE MICRO-GUIDE WIRE AND MICRO-CATHETER THROUGH THE OCCLUSION SEGMENT, WITHDREW THE MICRO-GUIDE WIRE. MICROCATHETER MICROANGIOGRAPHY SHOWED THAT THE DISTAL VASCULAR BED WAS WELL DEVELOPED, INTERMEDIATE CATHETER ANGIOGRAPHY SHOWED THAT THE THROMBUS LOAD CAPACITY. THEN THE SOLITAIRE FR 6MM"30MM STENT WAS SLOWLY PUSHED THROUGH THE MICROCATHETER. DURING THE PUSHING PROCESS, THE STENT WAS DIFFICULT TO PUSH, AND THE PUSH WAS DRY. AFTER PUSHING THE STENT INTO THE MICROCATHETER FOR 15CM, IT WAS STILL DIFFICULT TO PUSH THE STENT, AND THEN RETRACTED THE STENT. DURING THE RETRACTION PROCESS, THE STENT BROKE. THE DISTAL END OF THE STENT REMAINED IN THE MICROCATHETER, AND THE MICROCATHETER WAS WITHDRAWN (REBAR 18). UNDER THE GUIDANCE OF THE MICRO-GUIDE WIRE WITH MICROCATHETER (REBAR 27), PASSED THE MICRO-GUIDE WIRE AND THE MICRO-CATHETER THROUGH THE OCCLUDED SEGMENT

  Patient problems: Stenosis; Thromboembolism

  MAUDE report 15872506 ↗
• MalfunctionApr 7, 2022Leak/Splash; Leak/Splash

  MEDTRONIC RECEIVED INFORMATION REPORTING THAT A LEAK WAS OBSERVED AT THE DISTAL SEGMENT OF THE REBAR MICROCATHETER SHAFT DURING PREPARATION FOR USE. IT WAS NOTED THE CATHETER WAS PREPARED AND FLUSHED PER THE INSTRUCTIONS FOR USE (IFU). THE PHYSICIAN ATTEMPTED TO USE THE DEVICE ANYWAY BUT WHEN CONTRAST WAS INJECTED, CONTRAST LEAK WAS OBSERVED FROM THE LEAK LOCATION OBSERVED DURING PREPARATION. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. THE PATIENT WAS UNDERGOING AN ARTERIOVENOUS MALFORMATION EMBOLIZATION PROCEDURE WITH MICROPARTICLES. VESSEL TORTUOSITY WAS NORMAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14047398 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under 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