Lower risk Medical device recall · FDA · Published September 18, 2019

Angiodynamics BIOFLO 8F Port Recall: Delayed Implantation Risk

Angiodynamics recalls BIOFLO 8F titanium ports due to snap lock connector issues that may delay implantation procedures. Affected units have specific model numbers and were sold for long-term IV access.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0502-2020Medical device Angiodynamics ›

Lower-risk recall

Snap lock connectors provided within implantable port kits may not meet dimensional specifications, and the catheter cannot be inserted into the snap lock connector prior to connection to the port chamber, resulting in a delay to the implantation procedure.

Take action

Contact the company

Recalling firmAngiodynamics Inc. (Navilyst Medical Inc.)10 Glens Falls Tech Park · Glens Falls, NY 12801-3864

✎ GovInfoNow plain-language explainer

Angiodynamics recalls certain BIOFLO 8F titanium ports because their snap lock connectors might not fit properly, causing delays during implantation procedures. This could affect patients needing long-term IV access for treatments like chemotherapy. Read more at govinfonow.com/recall/66991-angiodynamics-bioflo-8f-port-recall-delayed-implantation-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/66991-angiodynamics-bioflo-8f-port-recall-delayed-implantation-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0502-2020

Cite this page

“Angiodynamics BIOFLO 8F Port Recall: Delayed Implantation Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/66991-angiodynamics-bioflo-8f-port-recall-delayed-implantation-risk. Based on FDA recall #Z-0502-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0502-2020%22&limit=1).

Angiodynamics Inc. (Navilyst Medical Inc.) recalled BIOFLO 8F SINGLE TITANIUM NON-FILLED; VALVED catheters on Sept. 18, 2019, according to the FDA. The snap lock connectors may not meet dimensional specifications, causing delays in implantation procedures.

How to tell if you have it

Brand: Angiodynamics
Product: BIOFLO 8F SINGLE TITANIUM NON-FILLED; VALVED
UPN: H965440250
Cat. No.: 44-025

The hazard

The snap lock connectors provided within implantable port kits may not meet dimensional specifications, and the catheter cannot be inserted into the snap lock connector prior to connection to the port chamber, resulting in a delay to the implantation procedure.

Context

GovInfoNow's records show Angiodynamics Inc. (Navilyst Medical Inc.) has had 8 other recalls on record since Oct. 17, 2017. Other recent recalls of similar products include Merit Medical BioFlo DuraMax Catheter Recall (Feb. 13, 2026), Angiodynamics Soft-Vu Catheter Recall (March 3, 2026), and Novapproach OneLIF Interbody Cage Recall (April 23, 2026).

How to tell if you have this one

Check for the model number H965440250 or catalog number 44-025 on the port device. These ports are used for long-term central venous access for treatments like chemotherapy.

Brand
Angiodynamics
Category
Medical device

FDA recall event · 5 products

All 5 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class II
Status
Terminated
Distribution
Worldwide distribution - US Nationwide in the state of CA, CT, FL, GA, IA, IN, KS, KY, MI, MO, MS, MT, NE, NJ, NY, OH, OK, OR, PA, TN, TX, WA, WI and country of Canada.

Recall number	Product, codes & lots
Z-0501-2020	BIOFLO 8F SINGLE PLASTIC FILLED; NON-VALVED, UPN H965440140, Cat. No. 44-014 - Product Usage: Long-term access to the central venous system for administration of fluids including but not limited to hydration fluids, chemotherapy, analgesics, nutritional therapy and blood products. The device is also indicated for blood specimen withdrawal.; 5487932, 5487933, 5488008
Z-0502-2020	BIOFLO 8F SINGLE TITANIUM NON- FILLED; VALVED, UPN H965440250, Cat. No. 44-025 - Product Usage: Long-term access to the central venous system for administration of fluids including but not limited to hydration fluids, chemotherapy, analgesics, nutritional therapy and blood products. The device is also indicated for blood specimen withdrawal.; 5488012
Z-0503-2020	BIOFLO 8F SINGLE PLASTIC NON-FILLED; VALVED, UPN H965440210, Cat. No. 44-021 - Product Usage: Long-term access to the central venous system for administration of fluids including but not limited to hydration fluids, chemotherapy, analgesics, nutritional therapy and blood products. The device is also indicated for blood specimen withdrawal.; 5478023
Z-0504-2020	BIOFLO 8F SINGLE PLASTIC FILLED; VALVED, UPN H965440220, Cat. No. 44-022; 5478033, 5482424
Z-0505-2020	XCELA, 8F SINGLE PLASTIC PORT FILLED, VALVED, UPN H965440400, Cat. No. 44-040 - Product Usage: Long-term access to the central venous system for administration of fluids including but not limited to hydration fluids, chemotherapy, analgesics, nutritional therapy and blood products. The device is also indicated for blood specimen withdrawal.; 5480564

Based on the official FDA remedy

What to do — step by step

Check Model Number
Look for the model number H965440250 or catalog number 44-025 on the port device.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 23 states.

FDA distribution: “Worldwide distribution - US Nationwide in the state of CA, CT, FL, GA, IA, IN, KS, KY, MI, MO, MS, MT, NE, NJ, NY, OH, OK, OR, PA, TN, TX, WA, WI and country of Canada.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: California, Connecticut, Florida, Georgia, Indiana, Iowa, Kansas, Kentucky, Michigan, Mississippi, Missouri, Montana, Nebraska, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Washington, Wisconsin.

Recall timeline

FDA terminated this recall 12 months after the firm started it.

Sep 18, 2019Firm started the recall
Nov 21, 2019FDA classified it Class II
Nov 27, 2019Published in FDA’s Enforcement Report
Sep 24, 2020FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/66991-angiodynamics-bioflo-8f-port-recall-delayed-implantation-risk">Angiodynamics BIOFLO 8F Port Recall: Delayed Implantation Risk (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-0502-2020 (September 18, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0502-2020 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.