RebarTM 105-5083-153Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00847536026858), received between Jun 24, 2022 and Feb 13, 2023 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 13, 2023Product Quality Problem; Product Quality Problem

  MEDTRONIC RECEIVED REPORT THAT AN EXPIRED REBAR MICROCATHETER WAS USED IN A PROCEDURE. THERE WAS NO HARM OR INJURY TO THE PATIENT. THE CATHETER DISCARDED AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16363550 ↗
• MalfunctionJul 19, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  MEDTRONIC RECEIVED INFORMATION THAT A REBAR CATHETER MARKER WAS NOT VISIBLE, THEREFORE THE CONCERTO COIL WAS MISPLACED AND FAILED PO SITIONING. THE COIL WAS NOT IMPLANTED AT THE INTENDED LOCATION. NO ADDITIONAL STEPS OR SURGICAL INTERVENTIONS REQUIRED TO REMOVE OR SECURE THE COIL. THE DEVICE DID NOT JUMP DURING DEPLOYMENT. THE VESSEL WAS NOT DAMAGED. THE TIP OF THE CATHETER WAS NOT UNDER STRESS. THE PHYSICIAN DID ROTATE THE DELIVERY PUSHER DURING THE PROCEDURE. THE ANEURYSM DID NOT RUPTURE. THE DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE CATHETER WAS FLUSHED AS PER IFU. ACCESS TO THE VESSEL WAS INGUINAL. THE ACCESS VESSEL DIAMETER WAS 8MM. VESSEL TORTUOSITY WAS MODERATE. THE EVENT DID NOT LEAD TO OR EXTENT PATIENT HOSPITALIZATION. NO TREATMENT WAS GIVE. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15060051 ↗
• MalfunctionJun 24, 2022Device Dislodged or Dislocated; Packaging Problem; Device Dislodged or Dislocated; Packaging Problem

  MEDTRONIC RECEIVED A REPORT THAT THE MARKER BAND WAS NOT VISIBLE ON THE MICROCATHETER. THE DEVICE WAS PREPARED AS INDICATED IN THE IFU. THE CATHETER WAS FLUSHED AS INDICATED IN THE IFU. THERE WERE NO SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THE EVENT. THE PATIENT WAS UNDERGOING EMBOLIZATION TREATMENT. THE PATIENT HAD MODERATE VESSEL TORTUOSITY. ANCILLARY DEVICES INCLUDE: DRYSEAL SHEATH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14803024 ↗

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