BioFlo 46470Recalls & reported problems
Navilyst Medical, Inc. · BioFlo Midline with ENDEXO Technology Maximal Barrier Nursing Kit · Class 2
All models of BioFlo (87)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI H965464700), received between Aug 23, 2017 and Feb 12, 2026 — classified as 2 injuries, 5 malfunctions.
The most frequently reported specific device problem is “Detachment Of Device Component” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Detachment Of Device Component1
- Detachment of Device or Device Component1
- Difficult to Remove1
- Fracture1
- Hole In Material1
- Material Frayed1
- Separation Failure1
Patient problems
- No Known Impact Or Consequence To Patient3
- Device Embedded In Tissue or Plaque1
- Foreign Body In Patient1
- No Clinical Signs, Symptoms or Conditions1
- Patient Problem/Medical Problem1
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 12, 2026Separation Failure
AN END-USER EXPERIENCED AN ISSUE WITH A GUIDEWIRE FROM A BIOFLO MIDLINE 4F SL-20CM MAX STERILE BARRIER NURSING KIT W/ TWO NITINOL GUIDEWIRE PG. IT WAS REPORTED THAT, AFTER MIDLINE INSERTION, RESISTANCE WAS FELT WHILE PULLING THE GUIDEWIRE BACK THROUGH THE SHEATH. THE ENTIRE SHEATH WAS PULLED FROM THE PATIENT, AND NO PRODUCT WAS RETAINED. UPON INSPECTION OF THE COMPONENTS REMOVED FROM THE PATIENT, THE GUIDEWIRE COULD NOT BE ADVANCED BACK THROUGH THE SHEATH AND HAD CAUSED DAMAGE TO THE INTRODUCER DURING ATTEMPTED WITHDRAWAL. THERE WERE NO ADVERSE EFFECTS OR PATIENT HARM REPORTED BECAUSE OF THIS INCIDENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24322902 ↗MalfunctionNov 25, 2025Material Frayed; Material Frayed
AN END-USER EXPERIENCE AN ISSUE WITH A GUIDEWIRE FROM A BIOFLO MIDLINE 4F SL-20CM MAX STERILE BARRIER NURSING KIT W/ TWO NITINOL GUIDEWIRE PG. IT WAS REPORTED THAT, DURING REMOVAL, FRAYING OF THE GUIDEWIRE WAS OBSERVED, AND FRAGMENTS WERE RETAINED WITHIN THE PATIENT'S TISSUE. THE PHYSICIAN WAS ABLE TO RETRIEVE THE RETAINED FRAGMENTS. THERE WERE NO ADVERSE EFFECTS OR PATIENT HARM REPORTED BECAUSE OF THIS INCIDENT.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 23653002 ↗MalfunctionOct 28, 2019Detachment of Device or Device Component; Detachment of Device or Device Component
AS REPORTED: HUB OF BIOFLO MIDLINE SEPARATED FROM THE CATHETER 1 HOUR AFTER INITIAL PLACEMENT. CATHETER WAS REMOVED AND REPLACED WITH A NEW OF THE SAME DEVICE. NO PATIENT INJURY OR COMPLICATIONS WERE REPORTED. IT WAS REPORTED THE DEFECTIVE DISPOSABLE DEVICE IS AVAILABLE FOR RETURN TO THE MANUFACTURER FOR EVALUATION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9244378 ↗InjuryDec 17, 2018Fracture; Fracture
AS REPORTED, DURING PLACEMENT OF BIOFLO MIDLINE CATHETER, THE GUIDEWIRE BECAME SEPARATED AND REQUIRED THE PATIENT TO HAVE A CUT-DOWN IN IR TO REMOVE THE WIRE.
Patient problems: Foreign Body In Patient
MAUDE report 8169468 ↗InjuryMar 8, 2018Difficult to Remove; Difficult to Remove
AS REPORTED: "MIDLINE PLACEMENT. REGISTER NURSE TRIED TO INSERT SHEATH OVER THE WIRE AND IT WOULD NOT ADVANCE. WHEN TRYING TO REMOVE THE WIRE, WIRE COULD NOT BE REMOVED FROM PATIENT'S ARM. PATIENT WAS SENT TO HAVE WIRE REMOVED BY A PHYSICIAN."
Patient problems: Patient Problem/Medical Problem
MAUDE report 7324345 ↗MalfunctionFeb 15, 2018Detachment Of Device Component; Detachment Of Device Component
AS REPORTED, THE PICC HUB DETACHED FROM THE EXTENSION LEG. THE DEVICE WAS REMOVED AND THE CATHETER WAS REPLACED. NO COMPLICATIONS TO THE PATIENT WERE REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7274490 ↗MalfunctionAug 23, 2017Hole In Material; Hole In Material
AS REPORTED, A 4F MIDLINE CATHETER WHICH HAD BEEN PLACED ON (B)(6) 2017 WAS FLUSHED PRIOR TO THE PATIENT GOING TO CT ON (B)(6) 2017. A PINHOLE LEAK WAS NOTED ON THE EXTENSION LEG AND THE CATHETER WAS REMOVED. THE PATIENT CONDITION WAS REPORTED AS "UNAFFECTED." IT HAS BEEN INDICATED THAT THE USED CATHETER WILL BE RETURNED TO ANGIODYNAMICS FOR EVALUATION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6813964 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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