The FDA has labeled a recall for the Medtronic (NYSE:MDT) Pipeline Flex embolization device and Pipeline Flex embolization device with Shield technology as Class I.
Medtronic wrote to customers risk of device fracture in February and later issued an urgent field safety notice to warn on specific production lots. The affected Pipeline Flex devices are available in the U.S., while the affected devices with Shield technology are not.
The Fridley, Minn.-based company manufactured the affected products from Oct. 22, 2019, to Feb. 1, 2020, and distributed them between Nov. 6, 2019, and Feb. 7, 2020. In total, Medtronic recalled 822 devices in the U.S.
Medtronic discovered the potential for fracture at the distal section during the use of the Pipeline Flex devices, due to a weakened bond in a subset of recently manufactured devices.
Use of the affected product could result in unintended separation, where the distal portion of the device delivery system remains in the patient, which could cause significant patient injury, including a prolonged procedure, ischemic stroke, intracranial hemorrhage, neurological deficit and/or death.
In its recall notice, the FDA said it received 50 medical device reports with 10 related injuries and one related death between Nov. 1, 2019, and March 1, 2020.
Pipeline Flex is designed for the endovascular treatment of adults with large or giant wide-necked intracranial aneurysms from the petrous to the superior hypophyseal segments. In February 2019, it won expanded FDA indication for patients with small or medium, wide-necked brain aneurysms in the territory from the petrous to the terminus of the internal carotid artery.
Users are urged to cease the use of any affected products, then remove and quarantine all unused affected products in their inventory. Then, users should return affected products to Medtronic and, if an alternative is needed, a Medtronic representative can assist with finding a suitable replacement.
