BioFlo 60M022474Recalls & reported problems
Navilyst Medical, Inc. · PICC Convenience Kit · 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 H96560M0224740), received between Apr 24, 2018 and Jun 5, 2018 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Fluid/Blood Leak1
- Tear, Rip or Hole in Device Packaging1
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.
MalfunctionJun 5, 2018Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
AS REPORTED BY END USER HOSPITAL, PRIOR TO USE THE PACKAGING OF A PICC KIT WAS NOTED TO HAVE A TEAR IN THE PACKAGING, THEREBY BREACHING THE STERILITY. THE DEVICE WAS NOT USED AND HAS BEEN RETURNED TO ANGIODYNAMICS FOR EVALUATION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7568592 ↗MalfunctionApr 24, 2018Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED, A PICC WAS PLACED BEDSIDE. AFTER PLACEMENT IT WAS FLUSHED AND SALINE WAS NOTED TO BE LEAKING OUT OF THE CATHETER NEAR THE HUB. THE CATHETER WAS REMOVED AND REPLACED. THERE WAS NO PATIENT INJURY OR COMPLICATIONS. THE USED DEVICE HAS BEEN RETURNED TO ANGIODYNAMICS FOR EVALUATION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7454563 ↗
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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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