MAHURKAR Dialysis Catheter Recalled for Excessive Lubricant Causing Occlusion
The MAHURKAR dialysis catheter is recalled because excessive silicone lubricant can obstruct the center lumen, potentially delaying critical dialysis treatment.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I recall. The defect risks treatment delay and serious complications (thrombosis, embolism, hemolysis) in dialysis patients. Although no injuries have been reported, FDA Class I classification mandates a minimum score of 4 (Severe) per the severity rubric.
Plain-English summary
The MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Straight Extensions, Kit (REF: 8888340637HP), manufactured by Covidien LP, is being recalled. Approximately 2,425 units have been distributed nationwide and internationally.
The defect involves the catheter's center lumen. An excessive amount of MDX, a silicone-based lubricant that coats the catheter tip, can cause the lumen to become occluded (blocked). The catheter may become partially or fully occluded, or uncured or excessive MDX may dislodge from the device. When this occurs, the result may be full catheter obstruction, delaying patient treatment, or partial obstruction that reduces blood flow through the catheter. Additionally, dislodged lubricant particles may lead to hemolysis (destruction of red blood cells), embolism (blood clot), or thrombosis (clot formation).
The affected lot numbers are: 1907700088, 2015100039, 2019500217, 2107700128, and 2113300287. The affected GTINs are: 10884521128088 and 20884521128085. The device has been distributed to facilities in the United States and numerous countries including Argentina, Brazil, Canada, China, France, Germany, India, Italy, Mexico, Netherlands, Philippines, Saudi Arabia, Singapore, Spain, Sweden, Thailand, Turkey, and the United Kingdom.
The recalled product
- Product
- MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Straight Extensions, Kit REF: 8888340637HP
- Manufacturer
- Covidien LP
- Hazard
- catheter-occlusion
- treatment-delay
- hemolysis
- embolism
- thrombosis
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- GTIN: 10884521128088
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- SevereMedtronic DLP Retrograde Cannula recalled for sterile barrier breach risk
FDA (Devices) · 2026-05-27
- HighAzurion X-ray System Deaeration Hose May Degrade and Cause Oil Leakage
FDA (Devices) · 2026-05-27
- HighSwan-Ganz Jr Catheter models recalled due to lumen hub leakage
FDA (Devices) · 2026-05-27
- SevereMedtronic DLP Retrograde Cannula Recalls for Sterile Barrier Breach Risk
FDA (Devices) · 2026-05-27
- HighMedtronic DLP Retrograde Cannula Cardiopulmonary Bypass Catheter Recall
FDA (Devices) · 2026-05-27