BioFlo 75-061Recalls & reported problems
Navilyst Medical, Inc. · BioFlo PICC with ENDEXO and PASV Valve Technology (4F x 55cm, Single Lumen) - Maximal Barrier Dual Fenestrated Drape Nursing Kit. · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI H965750610), received between Apr 14, 2023 and Apr 14, 2023 — classified as 1 injury.
The most frequently reported specific device problem is “Fracture” (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
Device problems
- Fracture1
Patient problems
- Foreign Body In Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryApr 14, 2023Fracture; Fracture
THE INSERTER PLACED THE GUIDEWIRE FROM A TANDEM BIOFLO PICC (V) 4FSL-55CM MAXIMAL BARRIER NURSING KIT . WHEN TRYING TO REMOVE THE GUIDEWIRE FROM THE PATIENT, THEY WERE UNABLE TO REMOVE IT. THE PICC PLACEMENT PROCEDURE WAS DISCONTINUED. AN XRAY WAS PERFORMED WHICH SHOWED THE WIRE HAD KNOTTED INSIDE THE PATIENT. THE PATIENT WAS BROUGHT TO IR THE NEXT DAY TO HAVE THE WIRE REMOVED. WHEN ATTEMPTING TO REMOVE THE GUIDEWIRE IN THE IR, THE KNOTTED PORTION BROKE OFF INSIDE THE PATIENT. GENERAL SURGERY ATTEMPTED TO RETRIEVE THE KNOT/FRAGMENT, BUT WERE UNSUCCESSFUL. THE FRAGMENT IS RETAINED INSIDE THE PATIENT. THE PATIENT WAS CLEARED BY SURGERY FOR DISCHARGE. A NEW PICC-LT SL BRACHIAL PLACED IN THE OPPOSITE ARM BY IR ON (B)(6) 2023.
Patient problems: Foreign Body In Patient
MAUDE report 16743227 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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