BioFlo 60M220444Recalls & reported problems
Navilyst Medical, Inc. · PICC Convenience Kit · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI H96560M2204440), received between Apr 4, 2017 and Apr 4, 2017 — classified as 1 malfunction.
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
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 4, 2017Fracture; Fracture
AS REPORTED, A PICC WHICH HAD BEEN PLACED ON (B)(6) 2017, WAS REMOVED AND REPLACED ON (B)(6) 2017 DUE TO LEAKAGE IN THE EXTENSION TUBE. THE PATIENT WAS AT HOME WHEN THE EVENT OCCURRED AND WAS USING THE PICC FOR ANTIBIOTIC DELIVERY. IT HAS BEEN INDICATED THAT THE USED CATHETER WILL BE RETURNED TO ANGIODYNAMICS FOR EVALUATION. THE PATIENT WAS NOT ADVERSELY AFFECTED BY THIS EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6456130 ↗
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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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