Covidien recalls MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheters with potential occlusion from 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 MAHURKAR dialysis catheters due to a risk of blockage from excessive silicone lubricant. This could delay treatment or cause complications like reduced blood flow or blood clots.
The catheter tip can become blocked by silicone lubricant (MDX) that coats it. This blockage may cause treatment delays, reduced blood flow, or blood clots if the lubricant dislodges from the catheter.
Patients receiving dialysis who use the recalled catheters are most at risk. Healthcare providers using these catheters in medical settings may also be affected.
Check for the model 'MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Curved Extensions, Kit' with lot numbers 1916500156, 2017400085, 2028300088, 2102600094, 2104600149, 2107700145, 2113100057, 2119400230, 2123000100, or 2133700164.
Look for the lot numbers listed in the recall notice: 1916500156, 2017400085, 2028300088, 2102600094, 2104600149, 2107700145, 2113100057, 2119400230, 2123000100, or 2133700164.
The recall states that excessive silicone lubricant (MDX) can cause blockages, so affected units should not be used until the remedy is applied. However, the remedy is not specified in the recall notice.
The recall does not provide specific action steps beyond checking the lot number. Contact the manufacturer for further guidance.
Check the lot number against the list provided: 1916500156, 2017400085, 2028300088, 2102600094, 2104600149, 2107700145, 2113100057, 2119400230, 2123000100, or 2133700164.
We’ve drafted a message you can send Covidien to request your refund or repair — edit it as you like.
Subject: Recall Z-2391-2023 — Covidien Covidien Hello, I own a Covidien that is covered by recall Z-2391-2023 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.