Sam Brusco, Associate Editor08.22.22
Medtronic’s recall of its Palindrome and Mahurkar hemodialysis catheters that began June 8 has been identified as Class I by the U.S. Food and Drug Administration (FDA).
The catheters, which were acquired from Covidien in the landmark 2015 acquisition, are implanted and used in hemodialysis, apheresis, and infusion. They were recalled due to a catheter hub defect that will connect both extension catheters. As a result, specific chronic dialysis catheters may potentially leak within the hub.
This might be recognized when flushing one extension tube and the flow through the catheter’s tip returns unexpected fluid through the adjacent extension tube. This leak could cause arterial and venous blood to be mixed, leading to increased recirculation and poor dialysis or development of thombi and emboli.
Using a defective catheter could cause bleeding, surgical removal, and replacement of the affected catheter. According to FDA, there’s been one complaint and no reports of death or injury at present.
Covidien (Medtronic) advised customers to immediately quarantine and discontinue use of the affected lots of hemodialysis catheters. The company also urged identifying the potential contamination of fluid, directing customers to flushing one extension tube to assess for unanticipated simultaneous fluid fluctuation in the adjacent extension tube.
The catheters, which were acquired from Covidien in the landmark 2015 acquisition, are implanted and used in hemodialysis, apheresis, and infusion. They were recalled due to a catheter hub defect that will connect both extension catheters. As a result, specific chronic dialysis catheters may potentially leak within the hub.
This might be recognized when flushing one extension tube and the flow through the catheter’s tip returns unexpected fluid through the adjacent extension tube. This leak could cause arterial and venous blood to be mixed, leading to increased recirculation and poor dialysis or development of thombi and emboli.
Using a defective catheter could cause bleeding, surgical removal, and replacement of the affected catheter. According to FDA, there’s been one complaint and no reports of death or injury at present.
Covidien (Medtronic) advised customers to immediately quarantine and discontinue use of the affected lots of hemodialysis catheters. The company also urged identifying the potential contamination of fluid, directing customers to flushing one extension tube to assess for unanticipated simultaneous fluid fluctuation in the adjacent extension tube.