BioFlo 46-023Recalls & reported problems
Navilyst Medical, Inc. · BioFlo Midline with ENDEXO Technology (4F x 20cm, Single Lumen) - Maximal Barrier Dual Fenestrated Drape Nursing 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 H965460230), received between Feb 17, 2021 and Feb 17, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Infusion or Flow Problem” (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
- Infusion or Flow Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 17, 2021Infusion or Flow Problem
AN ANGIODYNAMICS TERRITORY MANAGER REPORTED AN ISSUE WITH A BIOFLO MIDLINE 4F SL-20CM MAX BARRIER NURSING KIT. THE MIDLINE WORKED FOR 12 HOURS; HOWEVER, IT WOULD THEN ONLY INFUSE/ASPIRATE WHEN THE SUTURE WING WAS PUSHED DOWN FIRMLY. THE END USER ATTEMPTED TO TROUBLE SHOOT THE CAUSE AND INSTILLED TPA IN 3CC SYRINGE. AN ATTEMPT TO FLUSH10CC WAS UNSUCCESSFUL WHICH LED TO THE DISCOVERY THAT THE DEVICE WOULD INFUSE/ASPIRATE/DRAW BLOOD ONLY WHEN PUSHING DOWN ON SUTURE WING. THE FOLLOWING MEDICATIONS WERE INFUSED: VANCOMYCIN, NORMAL SALINE AT 100CC/HR, AND MEROPENEM. THE DEVICE WAS REMOVED AND A DIFFERENT DEVICE WAS UTILIZED. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS, HARM, OR REQUIRE MEDICAL INTERVENTION AS A RESULT OF THIS INCIDENT. THE REPORTED DEVICE HAS BEEN RETURNED TO THE MANUFACTURER AND AN INVESTIGATION INTO THE ROOT CAUSE FOR EVENT IS CURRENTLY IN PROGRESS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11339549 ↗
Other Midline catheter devices
- Midline Catheter Kit P4154108DBard Access Systems, Inc. · Midline catheter1 recall1 death126 reports
- ARROW IPN921959Teleflex Incorporated · Midline catheter2 recalls0 reports
- Midline Catheter Kit S4153108BDPBard Access Systems, Inc. · Midline catheter1 recall36 reports
- Midline Catheter Kit S4153108DBard Access Systems, Inc. · Midline catheter1 recall32 reports
- Midline Catheter Kit S4153108DGPBard Access Systems, Inc. · Midline catheter1 recall15 reports
- Midline Catheter Kit S4254108BDPBard Access Systems, Inc. · Midline catheter1 recall11 reports
- Midline Catheter Kit P4154108Bard Access Systems, Inc. · Midline catheter1 recall10 reports
- ARROW IPN037698Teleflex Incorporated · Midline catheter1 recall9 reports
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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