Vaxcel 60M780129Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI H96560M7801290), received between Oct 25, 2016 and Oct 25, 2016 — classified as 1 injury.

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

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryOct 25, 2016Material Fragmentation; Uncoiled; Material Fragmentation; Uncoiled

  AS REPORTED, "THE GUIDEWIRE HAD A SLIGHT BENT TO THE TIP BUT FED EASILY THROUGH THE NEEDLE AND INTO THE VEIN, AS WE ADVANCED WIRE, EASILY, FURTHER UP THE VESSEL THE WIRE MET RESISTANCE, TRIED TO PULL WIRE BACK BUT IT SNAGGED, TRIED TO PULL NEEDLE AND WIRE OUT TOGETHER, NEEDLE REMOVED EASILY BUT END OF WIRE WAS KINKED AND CURLED UNDER THE SKIN (AS SEEN ON FLUORO) AS WE TRIED TO GENTLY PULL THE WIRE OUT, THE FLOPPY END BEGAN TO SEPARATE FROM THE INNER WIRE AND UNCOIL INTO A THIN THREAD THAT HAD TO BE CUT OUT OF THE PT'S ARM. POST FLUORO DID REVEAL THAT NO SEGMENTS WERE LEFT IN THE ARM. " THE USED GUIDEWIRE WILL BE RETURNED FOR EVALUATION.

  Patient problems: Foreign Body In Patient

  MAUDE report 6053370 ↗