Covidien recalls specific 12 Fr high-pressure triple lumen dialysis catheters due to silicone lubricant causing tip occlusion, potentially leading to 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 12 Fr high-pressure triple lumen acute dialysis catheters because the silicone-based lubricant (MDX) at the catheter tip can cause blockages. This may delay treatment or cause complications like reduced blood flow, hemolysis, or blood clots.
The silicone lubricant (MDX) coating the catheter tip can become excessive or uncured, causing blockages. This may lead to partial or full catheter obstruction, reducing blood flow or causing blood clots, which can delay critical treatment.
Patients using the recalled catheters for acute dialysis treatment are most at risk. Healthcare providers who use these catheters in medical settings may also be affected.
Check for the model name 'MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Curved Extensions, IC Tray' with the specific reference number 8888101003HP. The lot numbers listed include 2130900104 through 2230400208.
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 recalled catheter and discuss next steps.
The silicone-based lubricant (MDX) at the catheter tip can become excessive or uncured, causing blockages that may delay treatment or cause complications like reduced blood flow, hemolysis, or blood clots.
Check the model name and reference number on the catheter packaging or label. Contact your healthcare provider to determine if you have the recalled catheter and discuss next steps.
Yes, the silicone lubricant can cause blockages leading to treatment delays or complications such as reduced blood flow, hemolysis, or blood clots.
We’ve drafted a message you can send Covidien to request your refund or repair — edit it as you like.
Subject: Recall Z-2369-2023 — Covidien Covidien Hello, I own a Covidien that is covered by recall Z-2369-2023 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.
