BioFlo 46012Recalls & reported problems
Navilyst Medical, Inc. · BioFlo Midline with ENDEXO Technology MST-45 Kit · Class 2
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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI H965460120), received between Aug 26, 2019 and Aug 3, 2020 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Inability to Irrigate” (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
- Inability to Irrigate1
- Unraveled Material1
Patient problems
- Device Embedded In Tissue or Plaque1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 3, 2020Inability to Irrigate; Inability to Irrigate
AN ANGIODYNAMICS TERRITORY MANAGER REPORTED AN ISSUE WITH A BIOFLO MIDLINE 4F CATHETER. ONE DAY AFTER PLACEMENT, THE MIDLINE WOULD NOT FLUSH. AFTER SEVERAL TROUBLESHOOTING ATTEMPTS, THE LINE WAS REMOVED. THE CATHETER COULD NOT BE FLUSHED, EVEN AFTER REMOVAL. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR HARM AS A RESULT OF THIS INCIDENT AND HAD ANOTHER BIOFLO FR CATHETER INSERTED. IT WAS INDICATED THE REPORTED DEVICE IS AVAILABLE FOR RETURN TO THE MANUFACTURER FOR A DEVICE EVALUATION.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10359633 ↗InjuryAug 26, 2019Unraveled Material; Unraveled Material
AS REPORTED: GUIDEWIRE BECAME STUCK IN VESSEL AND COULD NOT BE REMOVED. ALSO STUCK AT THE END OF SHEATH DILATOR. NOT REPORTED TO (B)(6) (BY ACCOUNT) AS IT IS SUSPECTED AS USER ERROR. THE GUIDEWIRE TIP HAS SPLIT POSSIBLY CAUSED BY BEING SHEARED BY THE NEEDLE. GUIDEWIRE WAS REMOVED BY IR. NEW LINE WAS SITED. NO SERIOUS PATIENT INJURY OR COMPLICATIONS WERE REPORTED. THE REPORTED DEFECTIVE DISPOSABLE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 8932204 ↗
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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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