According to a news article posted on neuronewsinternational.com, Medtronic has issued a recall of its Pipeline Flex Embolization Devices with Shield Technology products and its Pipeline Flex Embolization Devices due to reports of the delivery system’s tubes and wire fracturing and snapping off during placement, retrieval, or movement, leaving a piece of the stent inside the patient. So far, 59 reports of device malfunctions, with ten patients being seriously injured and two patient fatalities.
Medtronic’s Pipeline Flex Embolization devices are permanent, flow-diverting stents used for endovascular treatment of specific wide-necked intracranial aneurysms inside of the internal carotid artery (ICA). The recalled embolization devices come with a guidewire-based delivery system that places the implant inside of the patient’s internal carotid artery (ICA).
The U.S. Food and Drug Administration (FDA) statement says the recall is limited to 8,825 Pipeline Flex embolization devices in the United States. The FDA also classified this recall as a Class I recall, which is the most severe type of recall as the use of these medical devices may cause serious injuries or death.
The FDA recall announcement also states that pieces of the Pipeline Flex embolization device’s delivery system could fracture and be left inside the patient’s brain bloodstream. In some cases, emergency surgery to try and retrieve the fractured pieces could worsen the patient’s medical condition. These embolization device fragments could cause severe adverse health consequences, such as blockage of blood vessels, death, and strokes.
Medtronic issued an urgent medical device recall letter to its customers urging them to:
- Halt the use of any recalled products.
- Quarantine all unused recalled products
- Return the recalled products to Medtronic
- Communicate with your Medtronic representative for assistance with device returns or for help identify a proper replacement product if needed.
- Fill out and return the customer response form by email or fax or to Medtronic
Additional news and information concerning model numbers affected, the recall, and contacting Medtronic or the FDA about this recall, can be found here.
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