Rebar 105-5083-153Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00836462002234), received between Aug 17, 2019 and May 21, 2024 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 21, 2024Burst Container or Vessel; Physical Resistance/Sticking; Burst Container or Vessel; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED THAT IT WAS CLARIFIED THAT GLUE EMBOLIZATION IS DONE TO COMBAT THE BLEEDING AFTER RUPTURE. THE CAUSE OF THE ISSUE WAS NOT DETERMINED. THE PHYSICIAN PAUSED WHEN THE HIGH PRESSURE WAS FELT, THEN THEY CONTINUED TO INJECT AFTERWARDS THEN IT RUPTURED. THE INJECTION RATE WAS FOLLOWED AS INDICATED IN THE COMPETITOR'S IFU, 0.25ML PER 90S. THE LIQUID EMBOLIC AGENT DID NOT GET EMBEDDED IN AN UNINTENDED LOCATION. THIS EVENT DID NOT REQUIRED MEDICAL INTERVENTION.

  Patient problems: Clinical Endoleak; Hemorrhage/Blood Loss/Bleeding; Intracranial Hemorrhage; Rupture

  MAUDE report 19360419 ↗
• MalfunctionOct 20, 2023Break; Packaging Problem; Break; Packaging Problem

  MEDTRONIC RECEIVED A REPORT THAT WHEN IT WAS OPENED AND TAKEN OUT, THERE WAS A CRACK AT THE TIP/DISTAL SHAFT. THE REBAR WAS PREPARED AS INDICATED IN THE PACKAGE INSERT. THE CATHETER WAS FLUSHED AS INDICATED IN THE IFU. THIS EVENT WAS NOT ASSOCIATED WITH A PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17978661 ↗
• MalfunctionAug 17, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  MEDTRONIC RECEIVED REPORT THAT DURING A COILING PROCEDURE, ONE REBAR CATHETER WAS PUNCTURED BY A GUIDEWIRE, A SECOND REBAR WAS NOT VISIBLE UNDER FLUOROSCOPY. THE FIRST REBAR 18 CATHETER WAS PUNCTURED IN THE MIDDLE SECTION BY A STIFF 018 GUIDEWIRE. FRICTION WAS FELT WHEN THE GUIDEWIRE WAS INSERTED IN TO THE CATHETER. NO OTHER DAMAGE WAS NOTED TO THE CATHETER. A SECOND REBAR MICROCATHETER 18 WAS NOT VISIBLE UNDER FLUOROSCOPY. THE FRAME RATE WAS INCREASED AND ZOOMED IN BUT THE MICROCATHETER WAS STILL NOT VISIBLE. THE DEVICES WERE PREPARED AND USED PER THE INSTRUCTIONS FOR USE (IFU). THE CATHETERS WERE FLUSHED AS PER THE IFU. THERE WAS NO ALLEGATION OF DAMAGE TO THE OUTER OR INNER PACKAGING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8904280 ↗
• MalfunctionAug 17, 2019Device Damaged by Another Device; Device Damaged by Another Device

  MEDTRONIC RECEIVED REPORT THAT DURING A COILING PROCEDURE, ONE REBAR CATHETER WAS PUNCTURED BY A GUIDEWIRE, A SECOND REBAR WAS NOT VISIBLE UNDER FLUOROSCOPY. THE FIRST REBAR 18 CATHETER WAS PUNCTURED IN THE MIDDLE SECTION BY A STIFF 018 GUIDEWIRE. FRICTION WAS FELT WHEN THE GUIDEWIRE WAS INSERTED IN TO THE CATHETER. NO OTHER DAMAGE WAS NOTED TO THE CATHETER. A SECOND REBAR MICROCATHETER 18 WAS NOT VISIBLE UNDER FLUOROSCOPY. THE FRAME RATE WAS INCREASED AND ZOOMED IN BUT THE MICROCATHETER WAS STILL NOT VISIBLE. THE DEVICES WERE PREPARED AND USED PER THE INSTRUCTIONS FOR USE (IFU). THE CATHETERS WERE FLUSHED AS PER THE IFU. THERE WAS NO ALLEGATION OF DAMAGE TO THE OUTER OR INNER PACKAGING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8904279 ↗

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