Medtronic is recalling several models of its Pipeline Flex embolization device and Pipeline Flex embolization device with Shield Technology.
In light of the recall, the FDA issued a notice that categorized the recall as Class I. This signifies that the recalled devices can cause serious injuries or even death in patients.
What is a pipeline embolization device?
The pipeline embolization device (PED) is often seen as a revolutionary treatment for wide-neck intracranial aneurysms. Aneurysm occurs when there is an abnormal swelling or bulge at a weak spot in the wall of an artery.
This bulge can rupture and cause internal bleeding. The recalled Pipeline Flex embolization device is a cylindrical permanent mesh stent used in treating certain intracranial aneurysms. A guidewire-based delivery system is used to implant the stent.
Reason for Device Recall
Medtronic recalled the pipeline embolization devices because their delivery system’s wire and tubes could fracture and break off while the system is in use during the placement, retrieval, or movement of the stent inside a patient.
According to the recall notice posted on the FDA’s website, fractured pieces of the device could remain inside the patient’s brain bloodstream.
Furthermore, it is also possible that an attempt to retrieve the fractured pieces may make a patient’s condition worse. Fragments of the device can also pose other serious health consequences, including:
- Continued blockage of blood vessels
The FDA has identified this recall as Class I, the most serious type of recall because of the possibility that the device could cause serious injuries and even death.
To date, reports of incidence related to the device recall include:
- 59 device malfunctions
- 10 serious injuries
- 2 deaths
The recall affects 8,825 devices in the United States. The products were distributed between April 18, 2019, and August 13, 2020.
The products being recalled have the following numbers:
- Pipeline Flex Embolization Device: PED-250-XX, PED-275-XX, PED-300-XX, PED-325-XX, PED-350-XX, PED-375-XX, PED-400-XX, PED-425-XX, PED-450-XX, PED-475-XX, PED-500-XX
- Pipeline Flex Embolization Device with Shield Technology: PED2-250-XX, PED2-275-XX, PED2-300-XX, PED2-325-XX, PED2-350-XX, PED2-375-XX, PED2-400-XX, PED2-425-XX, PED2-450-XX, PED2-475-XX, PED2-500-XX
Not the First Time for Medtronic
It’s not the first time Medtronic has been caught in device recall issues. In March 2020, the company also had a Class I recall for Pipeline flex due to problems with device fracture, as well.
Although that recall did not include Pipeline Flex products with Shield Technology, Medtronic recalled 822 devices in the US. 50 medical device reports were made in relation to that recall, including 10 injuries and one death.
It is also important to note that in April of this year, the company just got an FDA nod for the Pipeline Flex embolization device with Shield Technology. With the latest medical device recall notice, Medtronic asks customers to stop using any of the affected products, with instructions to immediately quarantine all unused recalled products.
Impacted products should be returned to Medtronic. Customers with questions may contact Medtronic Quality Assurance by phone at 1-800-633-8766 (US toll free), or by email at email@example.com.
Any adverse reactions or problems related to this recall should be reported to the FDA’s MedWatch program.