Z-0132-2023Class II

Vortex MP Port Titanium Low Profile Implanted Port with 5F attached Silicone Catheter and Tray. Indicated for...

Name: Z-0132-2023 Vortex MP Port Titanium Low Profile Implanted Port with 5F attached Silicone Catheter and Tray. Indicated for...
Creator: Angiodynamics, Inc.
Published: 2022-09-20
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2022-09-20 / Open, Classified / root cause: labeling and UDI

FDA source

Angiodynamics, Inc. began a recall of Vortex MP Port Titanium Low Profile Implanted Port with 5F attached Silicone Catheter and Tray. Indicated for central venous placement (either peripheral or... on 2022-09-20. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0132-2023
Classification: Class II
Status: Open, Classified
Initiated: 2022-09-20
Posted: 2022-10-25
Recalling firm: Boston Scientific Corporation
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
Product code: LJT Port & Catheter, Implanted, Subcutaneous, Intravascular
Reason for recall: 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.
Root cause tag: labeling and UDI
FDA root cause: Under Investigation by firm
Action: Angiodynamics issued Urgent Medical Device Correction Letter on 09-20-2022 via Federal Express. Letter states reason for recall, health risk and action to take: Identify if any of the affected product is in your inventory (whether in labs, Central Supply, Shipping and Receiving or ANY other location). " Place the supplied Instructions for Use with each of the affected product(s) in your possession " Forward a copy of this recall notification and Instructions for Use to all sites to which you have distributed affected product. If you have any questions regarding the corrective action as stated above, please call AngioDynamics Customer Service at 1-800-772-6446 between 8:00 a.m. and 7:00 p.m. (Monday Friday: Eastern Standard Time). " If additional Instructions for Use are required, please note the quantity needed on the enclosed Reply Verification Tracking Form. " Promptly complete, sign, and return the enclosed Reply Verification Tracking Form (even if you do not have any product affected by this correction). Email Reply Verification Tracking Form (preferred): [email protected] Fax Reply Verification Tracking Form: Attn: Vortex MP Correction Coordinator Fax number 1-855-273-0519
Quantity in commerce: 11 units
Distribution: US Nationwide distribution in the states of AZ, CA, DC, IN, PA.
Product codes and lots: UDI-DI: 15051684018357 Lot Number: 5751582 Exp. Date: 31-Aug-2025

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0132-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0132-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-11-02	2022-10-25

Product code LJT

K033473Class IIModification to Vortex Mp Vascular Access PortHorizon Medical Products, Inc. / cleared 2003-11-18

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)