Medrad Intego PET Infusion System Recall

The Medrad Intego PET Infusion System recall includes Source Administration Sets that may expose patients to dangerous particulate matter. The recall has been designated Class II by the U.S. Food & Drug Administration (FDA), indicating the sets may cause temporary or medically reversible adverse health consequences.

Attorneys Representing Victims of Recalled Devices

Bernstein Liebhard LLP has represented hundreds of people who suffered injuries due to recalled medical devices. Our attorneys are now offering free, no-obligation legal reviews to cancer patients and others who developed infections or other complications following nuclear medicine treatment with the Medrad Intego Pet Infusion System. To learn if your might qualify to file a lawsuit, please contact our office by calling (888) 994-5118.

Bayer Recalls Source Administration Sets for Medrad Intego PET Infusion System

The Medrad Intego PET Infusion System controls and delivers medications during nuclear medicine procedures used in the diagnosis and treatment of cancer, thyroid disease, and heart disease. In November 2016, Bayer instituted a recall of Source Administration Sets used with the system after determining that the sets may produce a particulate matter in the medicine vials. The particulates may be created when the tip of the needle pushes through the rubber top of the vial. If particulate matter is allowed to enter a patient, serious adverse health consequences, including infection, damage of tissue, and death, may occur. The FDA designated Bayer’s action a Class II recall in January 2017.

The Source Administration Sets included in the Medrad Intego PET Infusion System recall were distributed between October 9, 2008 to October 11, 2016. Healthcare providers have been instructed to immediately discontinue  use and quarantine any unused affected product. Providers may then either:

  • Retain the quarantined sets to be used when a new qualified in-line filter is received.
  • Contact Bayer Customer Care at 1-800-633-7231 opt. 2 to arrange return of the product to the company.

Healthcare providers and patients should report adverse events or side effects related to the Medrad Intego PET Infusion System recall to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program.

Arrange for Your Free Case Review

Nuclear medicine patients who suffered infections or other complications due to Source Administration Sets included in the Medrad Intego PET Infusion System recall may be entitled to compensation for:

  • Medical bills
  • Lost wages
  • Pain and suffering
  • Emotional distress
  • Wrongful death

To discuss filing a Medrad Intego PET Infusion System lawsuit, please call (888) 994-5118 to arrange for your free case review.

  1. FDA (2017) “Medrad Intego PET Infusion System Source Administration Sets by Bayer: Recall – Particulates Generated in Vial”
  2. FDA (2016) “Class 2 Device Recall MEDRAD Intego PET Infusion System”
Last Modified: January 18, 2017

Get the latest news and litigation updates about this case by following us on Facebook. Click the "Like" button below.


Follow Us on Google+ on Facebook on LinkedIn on Twitter on YouTube on Pinterest

Skip to content