Vortex MP Port Titanium Recalled for Missing Printed Instructions
Angiodynamics is recalling 11 Vortex MP Port Titanium implantable ports because printed Instructions for Use were not shipped with the devices. Missing instructions could lead to improper implantation or post-operative care.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: This is a documentation issue—printed Instructions for Use were not shipped with the device. No illnesses or injuries have been reported, and the potential harm is theoretical, with the source stating only that improper use 'may result in' patient injury. Per the rubric, documentation issues without reported harm are classified as Low (1).
Plain-English summary
Angiodynamics, Inc. is recalling 11 Vortex MP Port Titanium Low Profile Implanted Ports with attached Silicone Catheters that were distributed in Arizona, California, Washington DC, Indiana, and Pennsylvania. The affected devices were shipped without printed Instructions for Use (IFU).
The Instructions for Use contain critical information about warnings, precautions, contraindications, and procedures for proper preparation, implantation, and post-operative care. Without these instructions, patients and healthcare providers may not follow required procedures, which could result in patient injury.
Patients who have received these implants should contact their healthcare provider immediately. The recalled devices have UDI-DI 15051684018357, Lot Number 5751582, and expire August 31, 2025.
Healthcare providers should obtain proper Instructions for Use from Angiodynamics before implanting these devices and notify affected patients of this recall.
The recalled product
- 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…
- Manufacturer
- Angiodynamics, Inc.
- Hazard
- Affected units
- 11
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI-DI: 15051684018357 Lot Number: 5751582 Exp. Date: 31-Aug-2025
Distribution
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