Medtronic has issued a recall of its Pipeline Flex embolisation device and Pipeline Flex embolisation device with Shield technology products due to a risk of the delivery system’s wire and tubes fracturing and breaking off during placement, retrieval, or movement, of the stent inside a patient. There have been 59 reported device malfunctions, 10 serious injuries and two deaths related to this recall to date.
Pipeline Flex embolisation devices are permanent, flow-diverting stents intended for the endovascular treatment of certain wide-necked intracranial aneurysms in the internal carotid artery (ICA). They also include a guidewire-based delivery system used to place the implant inside the patient.
According to a statement from the US Food and Drug Administration (FDA), the recall of these devices is limited to the Pipeline Flex embolisation device in the USA—with a total of 8,825 devices being recalled. Outside the USA, however, the recall applies to both the Pipeline Flex embolisation device and the Pipeline Flex embolisation device with Shield technology, which gained FDA approval in April 2021.
The FDA has identified this as a Class I recall—the most serious type of recall—as use of these devices may cause serious injuries or death.
Detailing the recall further, it states that fractured pieces of the Pipeline Flex embolisation device’s delivery system could be left inside the patient’s brain bloodstream, and that it is also possible that attempts to retrieve the fractured pieces may make the patient’s condition worse. These fragments can also cause other serious adverse health consequences, such as continued blockage of blood vessels, stroke, and death, the statement adds.
Healthcare providers using the Pipeline Flex embolisation device, and patients who require care with the device, may be affected by this recall, according to the FDA.
On 13 July 2021, Medtronic, the parent company of Micro Therapeutics (doing business as ev3 Neurovascular), sent an urgent medical device recall letter to customers requesting them to:
- Stop use of any impacted product. All unused impacted products should be immediately quarantined
- Return impacted products to Medtronic
- Contact your Medtronic representative for help with product returns or to identify a suitable replacement product if one is needed
- Complete and return the customer response form via fax or email to Medtronic
Further information on specific model numbers affected, and how to contact Medtronic or the FDA regarding this recall, can be found here.