Covidien recalls MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheters with potential occlusion due to excessive silicone lubricant. Affected units may cause delays in treatment or blood clots.
Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion an excessive MDX, a silicone-based lubricant which coats the catheter tip. An occluded, partially or fully, and/or uncured or excessive MDX may dislodge from the catheter lead to full catheter obstruction resulting in delay to treatment and partial obstruction resulting in reduced flow, or particulate dislodgement that may result in delay to treatment, hemolysis, embolism/embolus or thrombosis/thrombus
Covidien is recalling MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheters that may have an occlusion (blockage) at the tip due to excessive silicone lubricant. This can lead to treatment delays, reduced blood flow, or blood clots.
The catheter tip may become blocked by excessive silicone-based lubricant (MDX), which can cause partial or full blockages. This may delay treatment, reduce blood flow, or cause blood clots, leading to serious health issues.
Patients using hemodialysis treatments with this specific catheter model are most at risk. Healthcare providers who use the catheter for acute dialysis are also affected.
Check for the model name 'MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Straight Extensions, Kit' with the reference number 8888340637HP. The lot numbers listed are 1907700088, 2015100039, 2019500217, 2107700128, and 2113300287.
Identify the model name and reference number on the catheter packaging or label.
Reach out to your healthcare provider to determine if you have the affected catheter model and discuss next steps.
The catheter tip may become blocked by excessive silicone-based lubricant (MDX), which can cause partial or full blockages, leading to treatment delays, reduced blood flow, or blood clots.
Check the model and reference number on the catheter packaging. Contact your healthcare provider for guidance on whether to stop using it or if a fix is needed.
The recall record does not specify a remedy, so no immediate fix is provided. Healthcare providers should assess the situation.
We’ve drafted a message you can send Covidien to request your refund or repair — edit it as you like.
Subject: Recall Z-2381-2023 — Covidien Covidien Hello, I own a Covidien that is covered by recall Z-2381-2023 from Covidien. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.