Rebar 105-5081-153 (UDI 00763000412487)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00763000412487), received between May 31, 2025 and Sep 24, 2026 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (4 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 24, 2026Physical Resistance/Sticking

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50888672 ↗
• MalfunctionSep 24, 2026Physical Resistance/Sticking

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50888609 ↗
• MalfunctionSep 17, 2026Retraction Problem; Difficult to Advance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50805378 ↗
• MalfunctionJul 27, 2026Packaging Problem

  Medtronic received report that after opening the Rebar catheter box, it was observed that the sterile seal on the plastic pouch as not sealed; the sterile package was open. The device was not prepared or used. The Rebar catheter was replaced to continue the procedure. The issue was observed prior to use, thus there was no patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50017943 ↗
• MalfunctionMay 15, 2026Retraction Problem

  MEDTRONIC RECEIVED A REPORT THAT A SOLITAIRE FR STENT BECAME STUCK DURING USE. THE PATIENT WAS UNDERGOING THROMBECTOMY SURGERY FOR TREATMENT OF A ISCHEMIC STROKE IN THE LEFT INTERNAL CAROTID ARTERY. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS NORMAL. INTRAVENOUS TISSUE PLASMINOGEN ACTIVATOR (IV TPA) WAS NOT CONTRAINDICATED IN THIS CASE. THE PROCEDURE INVOLVED ONE PASS WITH THE DEVICE. THE STROKE ONSET TO REPERFUSION TIME WAS 107 MINUTES. IT WAS REPORTED THAT THE SOLITAIRE FR STUCK IN PATIENT'S BODY WITH THE MICROCATHETER, AND RETRIEVAL FAILED. AFTER REPLACING THE STENT, THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). ADDITIONAL INFORMATION WAS RECEIVED. THE LESION WAS A LEFT INTERNAL CAROTID ARTERY ANEURYSM WITH TERMINAL OCCLUSION. THE VESSEL TORTUOSITY WAS NORMAL. THE REPORTED STATEMENT OF ¿THE SOLITAIRE FR STUCK IN PATIENT¿S BODY WITH THE MICROCATHETER, AND RETRIEVAL FAILED¿ WAS CLARIFIED TO BE AS FOLLOWS: AFTER THE SOLITAIRE FR WAS PUSHED OUT FROM THE MICROCATHETER, REPOSITIONING WAS DESIRED DUE TO SUBOPT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25187452 ↗
• MalfunctionApr 8, 2026Loss of or Failure to Bond; Retraction Problem; Patient-Device Incompatibility; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE PATIENT WAS UNDERGOING TREATMENT FOR THROMBECTOMY OF THE M1 SEGMENT OF THE RIGHT MIDDLE CEREBRAL ARTERY. IT WAS NOTED THAT THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. THE ACCESS VESSEL WAS THE FEMORAL ARTERY, WITH 8MM DIAMETER. IT WAS REPORTED THAT DURING THE THROMBECTOMY PROCEDURE, AFTER DEPLOYMENT OF THE THROMBECTOMY STENT, THE OPERATOR WAS UNABLE TO WITH DRAW THE REBAR 18 WHILE PULLING IT BACK THROUGH THE WALLABY INTERMEDIATE CATHETER. INTRAOPERATIVELY, THE OPERATOR PERCEIVED THAT THE RESISTANCE WAS CAUSED BY INTERACTION BETWEEN THE OUTER COATING OF THE REBAR AND THE INNER COATING OF THE INTERMEDIATE CATHETER, AND THE RESISTANCE WAS SIGNIFICANT IN THE MIDDLE SECTION. AFTER MULTIPLE FORCEFUL WITHDRAWAL ATTEMPTS, THE REBAR 18 WAS EVENTUALLY REMOVED. THE PROCEDURE THEN PROCEEDED SMOOTHLY, WITH SUCCESSFUL RECANALIZATION AND CLOT RETRIEVAL. 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 WALLABY 5F 125CM ESPERANCE INTERMEDIATE CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24817409 ↗
• MalfunctionMay 31, 2025Retraction Problem; Deformation Due to Compressive Stress; Physical Resistance/Sticking; Retraction Problem; Deformation Due to Compressive Stress; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE DOCTOR COMPLAINED THE DEVICE WAS VERY STICKY AND HARD TO PUSH UP PRIOR TO FIRST DEPLOYMENT WITH THE DEVICE. IT WAS DETERMINED THE DEVICE WAS OVERSIZED FOR THE ANEURYSM. THE DOCTOR TRIED TO RECAPTURE THE DEVICE HOWEVER WAS UNABLE TO FULLY RECAPTURE THE DEVICE INTO THE REBAR 18. THE REBAR 18 AND DEVICE WERE REMOVED FROM THE PATIENT. ON THE STERILE FIELD THE DOCTOR TRIED TO PULL THE DEVICE BACK INTO THE REBAR 18 AGAIN AND WE VISUALLY SAW THE REBAR ACCORDION ON ITSELF. THE DOCTOR FOR THEIR OWN KNOWLEDGE OPENED A HEADWAY 21 AND THE DEVICE STILL COULDN¿T BE PUSHED THROUGH THE HEADWAY 21. ADDITIONAL INFORMATION RECEIVED REPORTED THE DEVICE GOT ¿STUCK¿ IN THE REBAR DURING RETRACTION. THE DOCTOR OPENED THE ARTISSE AND WHEN DECIDED TO USE ANOTHER SIZE, HE WAS RESHEATING THE DEVICE IN THE REBAR. IT WAS AT THAT POINT HE FELT IT GOT STUCK. WHEN HE FELT HE COULD NOT RESHEAT COMPLETELY, HE DECIDED TO PULL BACK THE ENTIRE SYSTEM, REBAR AND ARTISSE (INSIDE). ON THE TABLE, OUTSIDE THE PATIENT, WE SAW THE ACCORDION EFFECT AT THE DISTAL PART OF THE REBAR. NEW DEVICE AND NEW REBAR WERE CHOSEN AND ALL WENT FLUENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22120472 ↗

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