In July 2021, medical device manufacturer, Medtronic, initiated a device recall of some models of their Pipeline Flex embolization device. The Pipeline Flex device is used to treat brain aneurysms that balloon or bulge out the sides of affected blood vessels.
The braided tube is a permanent cylinder used to place, move, or retrieve stents placed in the blood vessel. The devices are made of platinum, cobalt-chromium-nickel, and tungsten alloy wires.
The device safety recall is due to the risk of wire and tubing breaking off from the device while in use. Fractured pieces of the device can enter the bloodstream and block blood vessels and blood supply. The risk includes worsening of the original condition, stroke, or even death.
Current reports state there have been 59 malfunctions, 10 serious injuries, and two deaths related to the problem.
Device Recall Expands
Now, the U.S. Food and Drug Administration (FDA) has announced there is an expansion to the device recall. Additional model numbers are now on the list of devices subject to the recall. Now, the list includes:
- 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
Patients potentially affected by the recall include those who have had a procedure using any of these devices.
The FDA has labeled this recall a Class I, which is the most serious designation. A Class I recall means that using the product has a high risk of causing injury or death.
What Patients Can Do
Patients who are affected by this device recall should contact their healthcare provider to report any symptoms related to a device malfunction. If you have a stent in place and are concerned about the recall, you can contact Medtronic’s Quality Assurance team at 1(800) 633-8766.
Patients affected by device recalls can also report their experience to the FDA via MedWatch: The FDA Safety Information and Adverse Event Reporting Program.
Healthcare providers should immediately stop using devices subject to the recall. All unused products should be quarantined and returned to Medtronic. Healthcare providers can also contact Medtronic for information about suitable replacement products.
Get Help after a Medical Device Injury
If you are suffering from a medical device injury, you likely have questions about your rights and if there is any legal recourse. At Drug and Device Watch, our team of medical device lawyers can help you find answers.
For a free legal consultation, call us at 888-458-6825. You can also reach us using our confidential online form.