Tuesday, 17 January 2017 14:06

Recall Of Pipeline Embolization Device

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The attention of the agency has been drawn to the recent recall of certain lots of its Pipeline Embolization Device, Alligator Retrieval Device, X-celerator Hydrophillic Guidewire and the Ultraflow and marathon flow Directed Micro Catheters by the Medtronic neurovascular products due to the potential separation of and detachment of the Polytetrafluoroethylene (PTFE) coating on parts of these devices.

The Pipeline embolization device is indicated for the endovascular treatment of adults (22 years of age and older) with large or giant wide-necked intracranial aneurysms in the internal carotid artery from the petrous to the superior hypophyseal segments.

The Alligator retrieval device is intended for use in the peripheral and neuro-vasculature for foreign body retrieval. The X-Celerator hydrophilic guidewire is indicated for general intravascular use to aid in the selective placement of catheters in the peripheral, visceral and cerebral vasculature during diagnostic and/or therapeutic procedures. The UltraFlow flow directed micro catheter is designed for the subselective infusion of physician-specified therapeutic agents such as embolization materials and diagnostic materials such as contrast media in tortuous, distal vessels. The Marathon Flow Directed Micro Catheter is intended to access peripheral and neuro vasculature for the controlled selective infusion of physician-specified therapeutic agents such as embolization materials and of diagnostic materials such as contrast.

REASON FOR RECALL:

 If PTFE separate from the delivery wire or stylets, PTFE particulate could enter the blood stream of the patient and PTFE in the blood stream, based on the size and quantity, could lead to a Thromboembolic event.

DETAILS OF THE PRODUCTS ARE:

PRODUCT NAMES:      Pipeline Embolization Device,

                                    Aligator Retrieval Device,

                                     X-celerator Hydrophillic Guidewire,

                                    Ultraflow flow Directed Micro Catheters,

                                    Marathon flow Directed Micro Catheters.

PRODUCT MANUFACTUIRER: Medtronic Neurovascular Products.

MANUFACTURING DATE: July to September, 2016

EXPIRY DATE:             Unknown.

See affected lots attached below.

NAFDAC encourages healthcare professionals and patients to report adverse events or side effects related to the use of these products to NAFDAC PRASCOR (20543-Toll free from all networks) or via This email address is being protected from spambots. You need JavaScript enabled to view it.

NAFDAC.........Safeguarding the health of the nation!!!

Read 1906 times Last modified on Tuesday, 17 January 2017 14:16

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