Angiodynamics Inc. (Navilyst Medical Inc.)

FDA recalling firm · 15 enforcement events · 78 product records · 2016–2021 · NY

Angiodynamics Inc. (Navilyst Medical Inc.) has 15 FDA enforcement events on this register (78 product records) between 2016 and 2021: 15 device; the busiest year was 2016 with 5.

0% of its events are Class I; the most common class is Class II (15). 0 events are listed as ongoing; the recalling firm's address is in NY.

Recall classification reflects the relative degree of health hazard. Event counts depend on a firm's size and product range; they are not a comparison of one firm with another.

Enforcement events

Initiated	Product (first record)	Type	Class	Records	Status
22 Feb 2021	Smart Port CT-Implantable Port Catalogue #: CT96STSD-VI, CT96STSA-VI - Product Usage: indicated for any patient requiring repeated access of the vascular system, for delivery of medications, nutritional supplementation, fluids, blood, blood products, and sampling of blood and power injection of contrast media for…	Device	Class II	2	Terminated
2 Oct 2019	Starburst Talon Semi-Flex Electrosurgical Device, Part Number H7877001028451 incorrectly labelled as Starburst MRI Semi-Flex Electrosurgical Device, Part Number H7877001026151	Device	Class II	1	Terminated
18 Sep 2019	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…	Device	Class II	5	Terminated
17 Apr 2019	AngioDynamics Solero Microwave Tissue Ablation (MTA) System: Solero Generator PG (1) Catalog Number:12740000 UPN: H78712740000 (2) Solero Generator US PG Catalog Number: 12740000US UPN: H78712740000US0 (3) Solero Generator Service Loaner PG Catalog No: 12740000L UPN: H78712740000L0 (4) Solero Generator Service Loaner…	Device	Class II	5	Terminated
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	Terminated
24 Jul 2018	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,…	Device	Class II	1	Terminated
10 May 2018	XCELA PASV 5F SL 55CM IR-145 Nitinol Wire KIT PG, Catalog Number 25-124	Device	Class II	38	Terminated
18 Jan 2018	Fluid Management Convenience Kits (Angioplasty Kits) intended to be used in Fluid Management and/or Invasive Pressure Monitoring systems.	Device	Class II	1	Terminated
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 peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications, and nutrients; the sampling of blood; and for power…	Device	Class II	1	Terminated
13 Jan 2017	NAMIC Fluid Delivery Set - 72" (183cm) UPN H965913000051, Catalog 91300005	Device	Class II	1	Terminated
28 Nov 2016	Xcela PICC Kit with ENDEXO and PASV Valve Technology, XCELA PASV 5F DL 55CM MST-70 Nitinol KIT PG, UPN H965251250, Catalog No. 25-125 The Xcela with PASV, BioFlo PICC with ENDEXO Technology, and BioFlo PICC with ENDEXO and PASV Valve Technology are indicated for short or long-term peripheral access to the central…	Device	Class II	13	Terminated
7 Sep 2016	Celerity ECG Cable Accessory Pack, STERILE, Rx ONLY - distributed under the following labels: (a) angiodynamics UPN/Product No. H787471431, REF/Catalog No. 47-143 -- Legal Manufacturer: AngioDynamics, Inc. 10 Glens Falls Technical Park, Glens Falls, NY 12801; and (b) medCOMP UPN/Product No. MRLCA000, REF/Catalog No.…	Device	Class II	1	Terminated
29 Aug 2016	Xcela Power Injectable PICC Maximal Barrier Nursing Kit The Maximal Barrier Nursing Kits are Tandem Pack Convenience Kits packaged with a NMI PICC and accessories. The Xcela Power Injectable PICC is indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but…	Device	Class II	3	Terminated
8 Jun 2016	Peripherally Inserted Central Catheters (PICC), UPN H965750141, Catalog # 75-014 The Maximal Barrier Nursing Kits are Tandem Pack Convenience Kits packaged with a NMI PICC and accessories. The BioFlo PICC with ENDEXO Technology and BioFlo PICC with ENDEXO and PASV Valve Technology are indicated for short or long-term…	Device	Class II	2	Terminated
21 Mar 2016	Vortex MEDICAL AngioVac Circuit, REF/UPN VTX3100, STERILE, Rx Only, Single Use Only -- The AngioVac Circuit and AngioVac Circuit Pack are designed to be used with the AngioVac Cannula.	Device	Class II	2	Terminated

By type and class

Device15

Class II15

Class I: 0% of this firm's events; 18% of all events on the register.

Events by year

Enforcement events for Angiodynamics Inc. (Navilyst Medical Inc.) by year initiated.

Questions and answers

How many FDA recalls has Angiodynamics Inc. (Navilyst Medical Inc.) had?

15 enforcement events (78 product records) on this register, 2016–2021: 15 device.

Are any Angiodynamics Inc. (Navilyst Medical Inc.) recalls ongoing?

0 events are listed as ongoing in the current openFDA export.

What class are Angiodynamics Inc. (Navilyst Medical Inc.) recalls?

15 Class II. 0% are Class I against 18% of all events on the register. Class reflects the relative degree of health hazard of the product, not the firm.

Where does this data come from?

openFDA food, drug and device enforcement reports (CC0), export dated 28 Sep 2026.

Provenance

Source: openFDA enforcement reports (CC0), export dated 28 Sep 2026. Firm names are grouped exactly as FDA spells them; the same company can appear under several spellings. Only organisations are shown. See the methodology.