The FDA has labeled the Medtronic recall of some Mahurkar hemodialysis catheters as Class I, the most serious kind.
Medtronic is recalling its Mahurkar 12 Fr high-pressure triple lumen acute dialysis catheters in 20 cm length with curved extensions due to occlusions in the tip of the catheter. The company said the source of the occlusion is an excessive MDX, a silicone-based lubricant that coats the catheter tip.
According to the FDA warning letter, an occluded, partially or fully, uncured or excessive MDX may dislodge from the catheter leading to full catheter obstruction to result in a delay to treatment and partial obstruction, resulting in reduced flow or particulate dislodgment that could result in a delay to treatment, hemolysis, embolism/embolus or thrombosis/thrombus.
Mahurkar high-pressure triple-lumen acute dialysis catheters are indicated for use in hemodialysis and use three tubes. It provides central venous access for hemodialysis and apheresis and the third lumen is designed for infusion. It can be used in short-term applications for less than 30 days.
There are 15,209 units involved in the recall with the following lot numbers: 1828200086, 1925300170, 1925300171, 2018800013, 2018800024, 2018800043, 2019500199, 2019500200, 2019500222, 2021000106, 2021000107, 2029600102, 2029600103, 2116600083, 2131200176, 2133700166, 2227800108, 2230400250, 2230400251, 2234800071.
This is Medtronic’s third recall of the Mahurkar hemodialysis catheters. In July 2022, the company’s subsidiary Covidien recalled more than 1 million Palindrome and Mahurkar hemodialysis catheters due to a catheter hub defect that connected both extension catheters. It issued another recall in January this year due to reports of a potential catheter hub defect that could cause leaks in a catheter’s tubes.
Medtronic noted in a recall letter in June that this recall does not include the Mahurkar Elite catheters, only the Mahurkar acute triple lumen catheters and the Mahurkar acute high-pressure triple lumen catheters.
Recommendations from the company
A replacement procedure is recommended for patients with affected lots currently in place. If a patient is found to have a catheter from an affected lot, the patient’s medical team should assess the overall patient risk when considering the timing of a replacement.
For healthcare providers, Medtronic is requiring them to determine if the products in their inventories are affected by the recall and immediately quarantine and discontinue use of all unused Mahurkar acute triple lumen catheters and Mahurkar acute high-pressure triple lumen catheters.
