BioFlo 45888Recalls & reported problems
Navilyst Medical, Inc. · BioFlo PICC with Endexo Technology - 6F x 55cm Dual Lumen Catheter IR-145 Kit with Nitinol Wire · Class 2 · Implant
All models of BioFlo (87)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI H965458880), received between Apr 5, 2018 and Apr 6, 2018 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Fracture” (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
Device problems
- Fracture2
Patient problems
- No Known Impact Or Consequence To Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 6, 2018Fracture; Fracture
AS REPORTED BY ANGIODYNAMICS' DISTRIBUTOR IN IRELAND, HOME TPN PATIENT WITH INDWELLING PICC EXPERIENCED A CRACKED HUB REQUIRING THE PICC TO BE REMOVED AND REPLACED. NO PATIENT INJURY OR COMPLICATIONS WERE REPORTED. THE USED PICC WAS RETURNED TO ANGIODYNAMICS FOR EVALUATION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7403178 ↗MalfunctionApr 5, 2018Fracture; Fracture
AS REPORTED BY ANGIODYNAMICS' DISTRIBUTOR IN (B)(4), HOME TPN PATIENT WITH INDWELLING PICC EXPERIENCED A CRACKED HUB REQUIRING THE PICC TO BE REMOVED AND REPLACED. NO PATIENT INJURY OR COMPLICATIONS WERE REPORTED. THE USED PICC WAS RETURNED TO ANGIODYNAMICS FOR EVALUATION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7400422 ↗
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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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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