BioFlo 60M701101Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI H96560M7011010), received between Dec 19, 2025 and Dec 19, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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.

• MalfunctionDec 19, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  A SPECTRUM DISTRIBUTOR REPORTED AN END USER EXPERIENCED AN ISSUE WHEN USING A CAN 4F SL BIOFLO PASV PICC - NURSING TRAY, CALGARY REGIONAL HEALTH AUTHORITY. PRIOR TO INSERTION, THE PICC WAS NOT WIPED WITH ANY CLEANING SOLUTION AND THE MARKERS WERE VISIBLE AFTER TWO HOURS OF BEING PLACED. THE PATIENT HAD THE PICC INSERTED HOWEVER, THE TIP WAS MALPOSITIONED IN HER RIGHT INTERNAL JUGULAR (IJ). THE PICC WAS LEFT OVER THE WEEKEND TO SEE IF IT WOULD DESCEND INTO THE SUPERIOR VENA CAVA (SVC). WHEN SHE WAS REASSESSED, IT WAS OBSERVED THAT THE CM MARKING NOTCHES AND EVERY 5CM NUMBER INDICATORS COULD NOT BE SEEN PAST THE 4CM MARK. THE PLAN WAS MADE TO EXCHANGE THE PICC TO A MIDLINE. WHEN THE PICC WAS REMOVED, IT WAS NOTED THAT MANY OF THE CM MARKINGS WERE DIFFICULT TO SEE AND THE WRITTEN NUMBER AT EVERY 5CM WAS "ERASED" AND UNABLE TO BE SEEN. IT WAS REPORTED THAT THE "MISSING" MARKERS WERE LOCATED OUTSIDE OF THE PATIENT'S SKIN AND WITHIN THE BLOOD STREAM.

  Patient problems: Foreign Body In Patient

  MAUDE report 23851355 ↗