Vortex MEDICAL AngioVac Circuit, REF/UPN VTX3100, STERILE, Rx Only, Single Use Only -- The AngioV...
FDA Device Recall #Z-1701-2016 — Class II — March 21, 2016
Recall Summary
| Recall Number | Z-1701-2016 |
| Classification | Class II — Moderate risk |
| Date Initiated | March 21, 2016 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Angiodynamics Inc. (Navilyst Medical Inc.) |
| Location | Glens Falls, NY |
| Product Type | Devices |
| Quantity | Domestic: 339 kits |
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.
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.
Distribution Pattern
Nationwide Distribution.
Lot / Code Information
Lot Numbers 37FE2901, 37GD2908, 37KD2405
Other Recalls from Angiodynamics Inc. (Navilyst Medical ...
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1467-2021 | Class II | AngioDynamics Safe Sheath Ultralite - Vascular ... | Feb 22, 2021 |
| Z-1466-2021 | Class II | Smart Port CT-Implantable Port Catalogue #: CT9... | Feb 22, 2021 |
| Z-0411-2020 | Class II | Starburst Talon Semi-Flex Electrosurgical Devic... | Oct 2, 2019 |
| Z-0504-2020 | Class II | BIOFLO 8F SINGLE PLASTIC FILLED; VALVED, UPN H9... | Sep 18, 2019 |
| Z-0501-2020 | Class II | BIOFLO 8F SINGLE PLASTIC FILLED; NON-VALVED, UP... | Sep 18, 2019 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.