Medtronic Recalls Over 22,000 Hemodialysis Catheters For Potential Hub Defect

Medtronic Recalls Over 22,000 Hemodialysis Catheters For Potential Hub Defect
  • Medtronic Plc MDT is recalling around 22,700 hemodialysis catheters due to a possible defect in the device’s hub that could result in leakages across the catheter’s tubes.
  • During treatment, the leak could mix the arterial and venous blood, lead to increased recirculation and poor dialysis, or cause blood clots in the blood vessels. 
  • The recall comes months after the FDA announced a recall of more than 1 million Medtronic Palindrome and Mahurkar hemodialysis catheters for a hub defect after receiving a complaint. 
  • Also Read: Medtronic Launches Insulin Pump Infusion Sets With Double Wear Time.
  • The implanted catheters filter waste and water from the blood, separate donated blood components for certain illnesses and infusions and can be used for up to 21 days.
  • The FDA said that using defective implanted catheters may cause serious adverse health outcomes, including bleeding or the need for surgical removal and replacement of the affected catheter. 
  • Two injuries related to the issue have been reported, and the FDA identified the recall as Class I, its most serious category.
  • The Mahurkar Acute Dual Lumen High Flow (13.5 French) Hemodialysis Catheters were distributed from Mar. 19, 2022, to Sept. 2, 2022. 
  • The FDA said that Medtronic initiated the recall of 22,763 devices on Nov. 23, 2022, and sent an Urgent Medical Device Recall letter on Dec. 7, 2022, advising clinicians to look for visible movement of catheter contents. 
  • The agency said that if the issue is detected, the patient’s medical team should use their clinical judgment to determine whether a replacement catheter is needed.
  • Price Action: MDT shares are down 0.62% at $82.07 during the premarket session on the last check Tuesday.

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