Covidien recalls 12 Fr High Pressure Triple Lumen Acute Dialysis Catheters with potential occlusion due to excessive silicone 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 certain acute dialysis catheters because silicone-based lubricant (MDX) can cause blockages. This may lead to treatment delays or serious complications like blood clots or embolisms.
The catheter tip can become blocked by excess silicone lubricant (MDX), which may cause partial or full blockages. This can delay treatment or cause blood clots, embolisms, or other complications.
Patients receiving dialysis who use the recalled catheters are most at risk. Healthcare providers using these catheters for acute dialysis treatments may also be affected.
Check for the model: MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Curved Extensions, IC Tray. The lot numbers 2130900107 and 2133700059 are affected.
Look for the model name and lot numbers on the catheter packaging or label.
The catheter tip can become blocked by excessive silicone lubricant (MDX), which may cause treatment delays or complications like blood clots or embolisms.
The recall record does not specify a remedy, so contact your healthcare provider for guidance.
Check for the model: MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Curved Extensions, IC Tray with lot numbers 2130900107 or 2133700059.
We’ve drafted a message you can send Covidien to request your refund or repair — edit it as you like.
Subject: Recall Z-2370-2023 — Covidien Covidien Hello, I own a Covidien that is covered by recall Z-2370-2023 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.