Covidien recalls MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheters with potential silicone lubricant occlusion causing blockages, 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 Triple Lumen Acute Dialysis Catheters that may have an occlusion in the catheter tip due to excessive silicone lubricant. This could cause blockages, delays in treatment, or blood clots if the catheter becomes obstructed.
The catheter tip may become blocked by excessive silicone lubricant (MDX), which can cause partial or full catheter obstruction. This might delay treatment, reduce blood flow, or lead to blood clots, embolisms, or other complications.
Patients using dialysis catheters made by MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheters with specific lot numbers are affected. Healthcare providers who use these catheters are at the highest risk.
Check for the MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 16 cm, Curved Extensions, Kit with lot numbers listed in the recall notice. The lot numbers include specific sequences like 1907700087 through 2033100069.
Identify if your catheter has a lot number from the list provided in the recall notice (e.g., 1907700087, 1915800147, etc.).
The catheter tip may have an occlusion due to excessive silicone lubricant (MDX), which can cause blockages, delays in treatment, or blood clots.
Check the lot number on your catheter against the list provided in the recall notice. If it matches, contact your healthcare provider for guidance.
The recall notice 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-2386-2023 — Covidien Covidien Hello, I own a Covidien that is covered by recall Z-2386-2023 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.