Food, drugs, devices › Angiodynamics Inc. (Navilyst Medical Inc.)

Device recall: BioFlo Port with ENDEXO and PASV Technology-AngioDynamics BIOFLO 8F SINGLE PLASTIC NON-FILLED; VALVED PG UPN: H965440210

FDA enforcement event 80913 · Class II · initiated 24 Jul 2018 · status Terminated · terminated 17 May 2019

DeviceVoluntary: Firm initiated1 product recordGlens Falls, NY

Angiodynamics Inc. (Navilyst Medical Inc.) (Glens Falls, NY) initiated this device recall on 24 Jul 2018; FDA lists 1 product record under event 80913, classified Class II.

FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 92% of the 1,074 device enforcement events initiated in 2018 carry the same class.

Status: Terminated, terminated 17 May 2019. Initiation: voluntary: firm initiated. Angiodynamics Inc. (Navilyst Medical Inc.) has 15 enforcement events on this register, with a median of 2 product records per event.

Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.

Recalling firm

Angiodynamics Inc. (Navilyst Medical Inc.), Glens Falls, NY.

Reason for recall

"BioFlo Ports was partially manufactured with the incorrect sterile port assembly. The actual sterile port assembly used was, 8F SL Xcela Plus Titanium Valved Non-Filled, when it should have been, 8F SL BioFlo Plastic Valved Non-Filled"

Distribution

"US Nationwide in the state of IN."

Product records

Recall number	Product	Quantity	Class	Status	Report date
Z-0076-2019	BioFlo Port with ENDEXO and PASV Technology-AngioDynamics BIOFLO 8F SINGLE PLASTIC NON-FILLED; VALVED PG UPN: H965440210 Catalog Number: 44-021 Box of 1 Port - Product Usage - Long-term access to the central venous system for administration of fluids including but not limited to hydration fluids, chemotherapy,…	1 box	Class II	Terminated	17 Oct 2018

Context

92%of 2018 device events are Class II1,074 events that year

1product record in this eventfirm median: 2

15events on this register for the firm

Other enforcement events for Angiodynamics Inc. (Navilyst Medical Inc.)

Initiated	Product (first record)	Type	Class	Records
22 Feb 2021	Smart Port CT-Implantable Port Catalogue #: CT96STSD-VI, CT96STSA-VI - Product Usage: indicated for any patient requirin	Device	Class II	2
2 Oct 2019	Starburst Talon Semi-Flex Electrosurgical Device, Part Number H7877001028451 incorrectly labelled as Starburst MRI Semi-	Device	Class II	1
18 Sep 2019	BIOFLO 8F SINGLE PLASTIC FILLED; NON-VALVED, UPN H965440140, Cat. No. 44-014 - Product Usage: Long-term access to the ce	Device	Class II	5
17 Apr 2019	AngioDynamics Solero Microwave Tissue Ablation (MTA) System: Solero Generator PG (1) Catalog Number:12740000 UPN: H78712	Device	Class II	5
16 Oct 2018	Xcela Power Injectable PICC with PASV (XCELA PASV 4F SL 55CM Catheter Kit CE PG), Cat no. 55-711	Device	Class II	2
10 May 2018	XCELA PASV 5F SL 55CM IR-145 Nitinol Wire KIT PG, Catalog Number 25-124	Device	Class II	38
18 Jan 2018	Fluid Management Convenience Kits (Angioplasty Kits) intended to be used in Fluid Management and/or Invasive Pressure Mo	Device	Class II	1
17 Oct 2017	Xcela PICC with PASV Valve Technology/Kit 5 F-55cm; (Maximum Flow Rate 3.5 mL/Sec)-indicated for short or long-term peri	Device	Class II	1
13 Jan 2017	NAMIC Fluid Delivery Set - 72" (183cm) UPN H965913000051, Catalog 91300005	Device	Class II	1
28 Nov 2016	Xcela PICC Kit with ENDEXO and PASV Valve Technology, XCELA PASV 5F DL 55CM MST-70 Nitinol KIT PG, UPN H965251250, Catal	Device	Class II	13

All 15 events for Angiodynamics Inc. (Navilyst Medical Inc.)

Questions and answers

Why was this device recalled?

FDA's record gives the reason for recall as: "BioFlo Ports was partially manufactured with the incorrect sterile port assembly. The actual sterile port assembly used was, 8F SL Xcela Plus Titanium Valved Non-Filled, when it should have been, 8F SL BioFlo Plastic Valved Non-Filled"

What does Class II mean?

FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

Where was the product distributed?

FDA's distribution pattern field reads: "US Nationwide in the state of IN."

Is the recall still ongoing?

FDA lists the status as Terminated; the termination date is 17 May 2019. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.

Where does this data come from?

openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.

Provenance

Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.