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Ten Injuries and One Death Lead to Medtronic Brain Stent Recall

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Braint stent

In February 2020, Medtronic recalled 1,812 units of its Pipeline Flex Embolization Device and Pipeline Flex Embolization Device with Shield Technology after it found the device’s delivery system could fracture during implantation.

In March, the U.S. Food and Drug Administration classified it as a Class I recall — the agency’s most serious recall for products that could cause serious harm or death. Of the products recalled globally, 822 were sold in the United States. 

Doctors use the embolization devices to treat brain aneurysms, bulges or sacs in blood vessels in the brain. The aneurysms can leak or rupture and cause life-threatening brain bleeds. 

Pipeline Flex Embolization Devices are cylinder-shaped, permanent mesh implants made of braided platinum, tungsten and cobalt-chromium-nickel alloy. Surgeons insert the devices with a guidewire delivery system into the body through a blood vessel in the leg and guide it to the site of the aneurysm. Doctors then release the stent, and it restricts blood from entering the bulge of the aneurysm. 

Medtronic recalled the devices because the delivery system could fracture, leaving the broken pieces in a patient’s brain. These pieces could then travel in the brain bloodstream. 

Complications from Device Fractures

Medtronic received 50 reports with 10 injuries and one death linked to the recalled devices from November 2019 to March 2020. 

Leaving fractured pieces in the body or attempting to remove them can worsen a patient’s condition. It can also cause other serious complications including stroke, blood vessel blockage and death. 

A search of the FDA’s Manufacturer and User Facility Device Experience (MAUDE) database shows about 500 adverse event reports related to the Pipeline Flex from May 8, 2019 to May 22, 2020. Because these reports are voluntary, the FDA cannot verify them. 

The company sent an Urgent Medical Device Recall Notice to their customers on Feb. 14, 2020. The letter advised customers to remove all affected products from their inventory and not to use them. Patients who already had the devices implanted don’t have any increased health risks from the recalled devices. 

Medtronic previously recalled its Pipeline Classic and Pipeline Flex in 2013, 2014, 2015 and 2016 for labeling problems, device malfunctions and a defective device coating that could flake off into the blood stream.

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Michelle Llamas, Senior Content Writer
Written By Michelle Llamas Senior Writer

Michelle Llamas has been writing articles and producing podcasts about drugs, medical devices and the FDA for seven years. She specializes in fluoroquinolone antibiotics and products that affect women’s health such as Essure birth control, transvaginal mesh and talcum powder. Michelle collaborates with experts, including board-certified doctors, patients and advocates, to provide trusted health information to the public. Some of her qualifications include:

  • American Medical Writers Association (AMWA) Engage Committee and Membership Committee member
  • Centers for Disease Control and Prevention (CDC) Health Literacy certificates
  • Original works published or cited in The Lancet, British Journal of Clinical Pharmacology and the Journal for Palliative Medicine
Edited By

8 Cited Research Articles

Drugwatch.com writers follow rigorous sourcing guidelines and cite only trustworthy sources of information, including peer-reviewed journals, court records, academic organizations, highly regarded nonprofit organizations, government reports and interviews with qualified experts. Review our editorial policy to learn more about our process for producing accurate, current and balanced content.

  1. U.S. Food and Drug Administration. (2013, August 23). Class 2 Device Recall Pipeline Embolization Device. Retrieved from https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=120283
  2. U.S. Food and Drug Administration. (2014, April 16). Class 1 Device Recall Pipeline Embolization Device. Retrieved from https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=126573
  3. U.S. Food and Drug Administration. (2015, October 14). Class 2 Device Recall Pipeline and Pipeline Flex. Retrieved from https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=140075
  4. U.S. Food and Drug Administration. (2016, November 9). Class 1 Device Recall Pipeline Embolization Device. Retrieved from https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=150126
  5. U.S. Food and Drug Administration. (2019, January 28). Pipeline Flex Embolization Device - P100018/S015. Retrieved from https://www.fda.gov/medical-devices/recently-approved-devices/pipeline-flex-embolization-device-p100018s015
  6. U.S. Food and Drug Administration. (2020, March 30). Medtronic Recalls Pipeline Flex Embolization Devices Due to Risk of Device Fracture. Retrieved from https://www.fda.gov/medical-devices/medical-device-recalls/medtronic-recalls-pipeline-flex-embolization-devices-due-risk-device-fracture
  7. U.S. Food and Drug Administration. (2020, March 9). ev3 Pipeline Flex Embolization Device. Retrieved from https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=180023
  8. U.S. Food and Drug Administration. (2020, March 9). ev3 Pipeline Flex Embolization Device with Shield Technology. Retrieved from https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=180025
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