Dialysis Catheters Recalled by FDA for Tip Obstruction Risk
Covidien is recalling MAHURKAR acute dialysis catheters because the center lumen tip may be occluded by excessive silicone-based lubricant. Obstruction could delay treatment or cause embolism and thrombosis.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class I medical device recall involving a manufacturing defect that can cause serious patient harm, including catheter obstruction, hemolysis, embolism, and thrombosis. The Class I classification mandates a minimum score of 4 per the rubric, despite no reported illnesses or deaths in the source text.
Plain-English summary
Covidien LP is recalling MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheters (REF: 8888345611HP). The recall involves 32,125 units distributed nationwide and internationally.
The center lumen of the catheter tip may contain an occlusion caused by excessive or uncured silicone-based lubricant (MDX). This defect can lead to complete or partial obstruction of blood flow through the catheter, or to dislodgement of lubricant particles into the bloodstream.
Healthcare providers should immediately discontinue use of affected catheters and check lot numbers against the recall list. Facilities must identify and segregate affected units to prevent patient use.
Potential complications from affected catheters include delayed dialysis treatment, hemolysis, embolism, and thrombosis.
The recalled product
- Product
- MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 16 cm, Curved Extensions, Kit REF: 8888345611HP
- Manufacturer
- Covidien LP
- Affected units
- 32,125
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 25 recalled by Covidien LP under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 25 products in this recall →Related recalls
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Same hazard · catheter obstruction
See all →- SevereDialysis catheter recall: excessive lubricant causes center lumen obstruction
FDA (Devices) · 2023-08-23
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- SevereDialysis Catheter Recalled for Center Lumen Occlusion Risk
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