Covidien recalls MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheters with potential occlusion due to excessive lubricant. Affected units may cause treatment delays or complications.
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 Triple Lumen Acute Dialysis Catheters that may have an occlusion (blockage) at the tip due to excessive lubricant. This could lead to treatment delays, reduced blood flow, or serious complications like blood clots or embolisms.
The catheter tip can become blocked by excessive lubricant (MDX), which may cause partial or full blockage. This blockage can delay treatment, reduce blood flow, or cause particles to dislodge, leading to blood clots, embolisms, or other serious complications.
Healthcare professionals using the catheter for acute dialysis treatments are most at risk. Patients receiving dialysis through this catheter may experience complications if the occlusion occurs.
Check for the model: MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 24 cm, Curved Extensions, Kit. The reference number is 8888345637. Lot numbers 2124600191 and 2127300121 are affected.
Inspect the catheter for signs of blockage at the tip, such as reduced flow or difficulty connecting to the dialysis machine.
The catheter tip may become blocked by excessive lubricant (MDX), which can cause treatment delays, reduced blood flow, or serious complications like blood clots or embolisms.
Check the reference number and lot numbers to confirm if your catheter is affected. If it is, contact your healthcare provider for guidance on next steps.
The recall record does not specify a remedy or fix for this issue.
We’ve drafted a message you can send Covidien to request your refund or repair — edit it as you like.
Subject: Recall Z-2390-2023 — Covidien Covidien Hello, I own a Covidien that is covered by recall Z-2390-2023 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.