Cathter Passer, Disposable 48407Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00643169466326), received between Dec 15, 2016 and Jun 10, 2020 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Break” (3 reports).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 10, 2020Break; Break

  IT WAS REPORTED THAT THE TIP OF THE INNER STYLET OF THE CATHETER PASSER BROKE OFF DURING USE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10140812 ↗
• MalfunctionMay 20, 2020Break; Break

  IT WAS REPORTED THAT THE PLASTIC BULLET TIP AT THE END OF THE TUNNELER BROKE/CAME OFF WHILE THE SURGEON WAS USING IT. THE TIP WAS UNABLE TO BE LOCATED; HOWEVER, THE SURGEON FELT LIKE IT WAS NOT LIKELY TO HAVE REMAINED IN THE PATIENT. A POST-OPERATIVE CAT SCAN WAS DONE, AND NEITHER THE RADIOLOGIST NOR THE SURGEON SAW EVIDENCE OF RETAINED FOREIGN BODY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10075473 ↗
• InjuryDec 15, 2016Break; Device Or Device Fragments Location Unknown; Break; Device Or Device Fragments Location Unknown

  IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT THE BACK END OF THE PASSER BROKE OFF INTRAOPERATIVELY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING ANOTHER PRODUCT AND THERE WAS NO INJURY TO THE PATIENT.

  Patient problems: Device Embedded In Tissue or Plaque; No Known Impact Or Consequence To Patient

  MAUDE report 6179165 ↗