RebarTM 105-5081-130Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00847536026810), received between Apr 12, 2019 and Mar 18, 2023 — classified as 4 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, K210114); 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.

• MalfunctionMar 18, 2023Display or Visual Feedback Problem; Display or Visual Feedback Problem

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THERE WAS NO LESION. VESSEL TORTUOSITY WAS NORMAL. THE CATHETER WAS BEING USED TO NAVIGATE TO AN EMBOLIZATION SITE, NOT THROUGH A LESION/STENOTIC ZONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16570236 ↗
• MalfunctionMay 29, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  MEDTRONIC RECEIVED INFORMATION THAT THE PHYSICIAN WAS UNABLE TO VISUALIZE THE CATHETER UNDER FLUOROSCOPY WHILE PERFORMING THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10101531 ↗
• MalfunctionJul 31, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  MEDTRONIC RECEIVED REPORT THAT THE REBAR WAS IMPOSSIBLE TO SEE, AS THE RADIOPAQUE MARKER WAS NOT VISIBLE. THIS LED TO THE COIL REMAINING IN THE REBAR WHEN IT WAS DETACHED. THE COIL WAS DAMAGED AND STRUNG. AFTER A COUPLE COILS, WE OPENED ANOTHER REBAR WITH THE SAME LOT NUMBER. THIS REPLACEMENT DEVICE DID HAVE A VISIBLE TIP, BUT IT IS WAS DIFFICULTY TO SEE. WE PUT IN A FINAL COIL AND ENDED THE CASE. THE MARKER WAS LOCATED AT THE END OF THE OF THE CATHETER, IT WAS JUST NOT VISIBLE UNDER FLUORO. NO PATIENT INJURY OCCURRED. THE DEVICE WAS PREPARED AND USED PER THE INSTRUCTIONS FOR USE (IFU). THE CATHETER WAS FLUSHED PER THE IFU.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8846840 ↗
• MalfunctionApr 12, 2019Material Deformation; Material Deformation

  MEDTRONIC RECEIVED REPORT THAT IT WAS UNABLE TO VISUALIZE THE TIP OF THE REBAR CATHETER UNDER FLUOROSCOPY. THEY ATTEMPTED TO MAGNIFY THE IMAGE BUT WERE STILL UNSUCCESSFUL LOCATING THE MICRO TIP. A NEW CATHETER WAS USED TO COMPLETE THE PROCEDURE. THIS EVENT OCCURRED DURING THE TREATMENT OF AN ARTERIOVENOUS MALFORMATION OF A LEFT SUBCLAVIAN ARTERY, VESSEL DIAMETER 10MM. THE ANATOMY WAS REPORTED TO HAVE BEEN NORMAL IN TORTUOSITY. THE DEVICE WAS DISCARDED AT THE SITE. THERE WAS NO ALLEGATION THAT THE DEVICE WAS DAMAGED PRIOR TO USE. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE TIP HAD BEEN SHAPED BY THE USER. THE CATHETER FLUSHED AS INDICATED IN THE IFU.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8511911 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K001966, K093750, K210114. 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