Angiodynamics recalls Vortex MP Port devices due to missing instructions for use, which could lead to patient injury if not followed properly. Affected units include specific model numbers and lot numbers.
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.
Angiodynamics is recalling Vortex MP Port Titanium Low Profile Implanted Ports with attached catheters and trays because the instructions for use were not shipped with the device. Without these instructions, patients could be injured during implantation or post-operative care.
The device comes without the printed instructions for use, which include critical warnings and procedures for safe implantation and post-operative care. If the instructions are not followed, patients could experience injury during the procedure or after the device is implanted.
Patients who have received the Vortex MP Port device with the specific model numbers and lot numbers listed in the recall are affected. Those with the device are at risk if they do not have the instructions for use.
Check for the model number MP-P5SAT, lot number 5751582, and expiration date of 31-Aug-2025 on the device packaging. The device is intended for central venous placement in patients needing repeated venous access for therapy.
Look for the printed instructions for use that were not shipped with the device. If missing, contact Angiodynamics for guidance.
The device was recalled because the printed instructions for use were not shipped with it, which could lead to patient injury if the instructions are not followed during implantation or post-operative care.
The affected model numbers include MP-P5SAT, lot number 5751582, and expiration date 31-Aug-2025.
No, but you should check for the instructions for use. If missing, contact Angiodynamics for guidance on next steps.
We’ve drafted a message you can send Angiodynamics to request your refund or repair — edit it as you like.
Subject: Recall Z-0132-2023 — Angiodynamics Angiodynamics Hello, I own a Angiodynamics that is covered by recall Z-0132-2023 from Angiodynamics. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
