FDA Device recall Z-0132-2023
Vortex MP Port Titanium Low Profile Implanted Port with 5F attached Silicone Catheter and Tray
- FDA Device
- Class II
- ongoing
- Published 2022-11-02
On 2022-11-02 the FDA classified a Class II recall of Vortex MP Port Titanium Low Profile Implanted Port with 5F attached Silicone Catheter and Tray by Angiodynamics, citing printed Instructions for Use (IFU) not shipped with device. The Instructions for Use contain the Warnings, Precautions, Contraindications, and Procedures for the Preparation, Impl….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0132-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-09-20 |
| Published | 2022-11-02 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Angiodynamics |
| Distribution | US |
Product
Vortex MP Port Titanium Low Profile Implanted Port with 5F attached Silicone Catheter and Tray. Indicated for central venous placement (either peripheral or chest placement) when patient therapy requires repeated venous access for injection or infusion therapy and/or venous blood sampling UPN: H787MPP5SAT0 Catalog Number: MP-P5SAT
Reason
Printed Instructions for Use (IFU) not shipped with device. The Instructions for Use contain the Warnings, Precautions, Contraindications, and Procedures for the Preparation, Implantation, and Post Operative Care of the implantable port, failure to follow the Instructions for Use may result in patient injury.
Identifiers
| code_info | UDI-DI: 15051684018357 Lot Number: 5751582 Exp. Date: 31-Aug-2025 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0132-2023%22
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