Recalls & Alerts Published by NAFDAC

Tuesday, 17 January 2017 14:06

Recall Of Pipeline Embolization Device

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!!!

The attention of the agency has been drawn to the recall of Heartware Ventricular Assist Device Pump (HVAD) by the Heartware Incorporate due to a design problem with the Driveline connector. The Driveline connector is a tube that connects the HVAD’s pump to the external controller and power source. The HVAD pump helps deliver blood from the heart to the rest of the body. It is used in patients who are at risk of death from end-stage left ventricular heart failure and those waiting for a heart transplant.

Reason for recall:

Contamination of the driveline may result in fluid or other materials entering the pump and causing electrical issues or pump stops that may lead to serious adverse health consequences including Death.

This recall affects all HVADs with serial numbers lower than HW25838, product codes 1103 and 1104, manufacturing dates are from March 17, 2006 to June 27, 2016, it has 105 units.

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!!!

 

The attention of the Agency has been drawn to the recent recall of all lots Megajex Natural sex Enhancer capsules by MS Bionic as a result of undeclared drug ingredients (i.e. ingredients not specified on the label). This product listed above contains Tadalafil and Sildenafil which are the active ingredients for Cialis and Viagra respectively, Tadalafil and Sildenafil are approved drugs used as treatment for male Erectile Dysfunction (ED).ED is a common problem in men with these conditions, and consumers may seek these types of products to enhance sexual performance.

Megajex Natural Male Sex Enhancer is marketed as a dietary supplement for erectile dysfunction. It is packaged in 20 count bottles and sold nationwide.

Use of this product may pose a threat to consumers because the undeclared active ingredients may interact with nitrates found in some prescription drugs (such as Nitroglycerin) and may lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates.

INFORMATION ON PRODUCTS DETAIL

  • Manufacturer: MS Bionic Incorporated.
  • Drug specification: 20 count bottles.

In view of this, the:

  • Patients taking these drugs should contact their health care professionals right away if they experience symptoms or any adverse effect related to the use of this product.
  • Healthcare professionals are implored to report adverse effect 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!!!

Page 3 of 7

CORPORATE LINKS