Angiodynamics Inc. (Navilyst Medical Inc.): Medical Device Recall in 2016 - (Recall #: Z-1701-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.
Product Description:

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.

Product Classification:

Class II

Date Initiated: March 21, 2016
Date Posted: June 1, 2016
Recall Number: Z-1701-2016
Event ID: 73815
Reason for Recall:

Maquet Cardiopulmonary, the manufacturer of the RotaFlow Centrifugal Pump, determined that the products may possess levels of endotoxin that exceed regulatory limits. AngioDynamics confirmed that the affected RotaFlow Centrifugal Pumps were included in packaged AngioVac Circuit Packs.

Status: Terminated
Product Quantity: Domestic: 339 kits
Code Information:

Lot Numbers 37FE2901, 37GD2908, 37KD2405

Distribution Pattern:

Nationwide Distribution.

Voluntary or Mandated:

Voluntary: Firm initiated