Xcela 45652Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI M001456520), received between Sep 12, 2018 and Sep 12, 2018 — classified as 2 malfunctions.

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

• MalfunctionSep 12, 2018Unraveled Material; Unraveled Material

  AS REPORTED - DURING PLACEMENT OF AN XCELA PICC, THE WIRE MANDREL WAS IN THE VEIN WITH THE NEEDLE REMOVED. WHEN ATTEMPTING TO THREAD THE END OF THE WIRE THROUGH THE INTRODUCER, THE END OF THE WIRE WAS NOTED TO BE UNRAVELLING. THE WIRE WAS REMOVED AND THE PATIENT'S VEIN RE-ACCESSED THROUGH A SECOND NEEDLE PUNCTURE. THE USED GUIDEWIRE WILL NOT BE RETURNED FOR EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7868101 ↗
• MalfunctionSep 12, 2018Unraveled Material; Unraveled Material

  AS REPORTED - THE WIRE MADREL PACKAGED WITH THE XCELA PICC WAS ADVANCED APPROXIMATELY 10 CM INTO THE PATIENT'S VEIN WHEN RESISTANCE WAS MET. THE NEEDLE WAS REMOVED AND THEN THE WIRE. THE WIRE WAS UNRAVELING WHEN BEING REMOVED AND ONE PIECE OF WIRE WAS IN THE PATIENT'S VEIN AND WAS EVENTUALLY REMOVED. " NO PRODUCT WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7868092 ↗