FDA Device recall Z-1701-2016
Vortex MEDICAL AngioVac Circuit, REF/UPN VTX3100, STERILE, Rx Only, Single Use Only -- The AngioVac Circuit and AngioVac Circuit Pack are d…
- FDA Device
- Class II
- terminated
- Published 2016-06-01
On 2016-06-01 the FDA classified a Class II recall of Vortex MEDICAL AngioVac Circuit, REF/UPN VTX3100, STERILE, Rx Only, Single Use Only -- The AngioVac Circuit and AngioVac Circuit Pack are d… by Angiodynamics Navilyst Medical, citing maquet Cardiopulmonary, the manufacturer of the RotaFlow Centrifugal Pump, determined that the products may possess levels of endotoxin that exceed regulatory limits. AngioDynamic….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1701-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-03-21 |
| Published | 2016-06-01 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Angiodynamics Navilyst Medical |
| Distribution | US |
Product
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.
Reason
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.
Identifiers
| code_info | Lot Numbers 37FE2901, 37GD2908, 37KD2405 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1701-2016%22
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