The FDA has issued a Class I recall of the Medtronic Pipeline Flex embolization device and the Pipeline Flex embolization device with shield technology.
The 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 has recalled 822 devices in the U.S.
Medtronic discovered the potential for fracture at the distal section of the instruments 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. This could lead to significant patient injury, ischemic stroke, intracranial hemorrhage, neurological deficit, and/or death.
Users are urged to cease the use of any affected products and return them to Medtronic. If an alternative is needed, a Medtronic representative can assist with finding a suitable replacement