Sam Brusco, Associate Editor01.30.23
The U.S. Food and Drug Administration (FDA) has deemed Medtronic’s November 23, 2022 recall of its Mahurkar acute dual lumen high-flow hemodialysis catheters for a potential catheter hub defect as Class 1.
The 13.5 French Mahurkar catheters are implanted and used in hemodialysis, apheresis, and infusion for up to 21 days. Medtronic recalled the catheters because of a hub defect that can cause leaks across the catheter’s tubes. During treatment, the leak could cause mixing of arterial and venous blood, lead to increased recirculation and poor dialysis, or bring about blood clot development in the blood vessels.
Using the defective catheter can cause bleeding or the need to surgically remove and replace the affected catheter. Thus far, there have been reports of two injuries related to the issue, and no deaths reported.
Customers were advised to immediately quarantine and discontinue use of all the affected lots of unused Mahurkar catheters. 22,763 device were recalled in the U.S., distributed between March 19, 2022 and September 2, 2022.
The 13.5 French Mahurkar catheters are implanted and used in hemodialysis, apheresis, and infusion for up to 21 days. Medtronic recalled the catheters because of a hub defect that can cause leaks across the catheter’s tubes. During treatment, the leak could cause mixing of arterial and venous blood, lead to increased recirculation and poor dialysis, or bring about blood clot development in the blood vessels.
Using the defective catheter can cause bleeding or the need to surgically remove and replace the affected catheter. Thus far, there have been reports of two injuries related to the issue, and no deaths reported.
Customers were advised to immediately quarantine and discontinue use of all the affected lots of unused Mahurkar catheters. 22,763 device were recalled in the U.S., distributed between March 19, 2022 and September 2, 2022.