MAHURKAR dialysis catheters recalled for center lumen occlusion risk
Covidien LP recalls MAHURKAR dialysis catheters due to excessive silicone lubricant on the catheter tip, which can obstruct the center lumen. This may delay treatment and cause serious blood complications including embolism and thrombosis.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This recall is classified as Severe because it is an FDA Class I medical device recall, which requires a minimum severity score of 4. Although no illnesses or injuries have been reported, the device poses significant risk of serious complications including hemolysis, embolism, and thrombosis in dialysis patients.
Plain-English summary
Covidien LP is recalling MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheters, 16 cm with Curved Extensions (REF: 8888345611). The recall affects 69,987 units distributed nationwide and internationally. Specific affected lot numbers have been identified by the manufacturer.
The center lumen of affected catheters can become partially or fully occluded due to excessive coating of MDX, a silicone-based lubricant applied to the catheter tip. This occlusion can prevent normal fluid flow through the catheter or cause particulate matter to dislodge.
An obstructed or partially obstructed catheter may delay treatment and reduce blood flow. Particulate dislodgement from the catheter could cause hemolysis (destruction of red blood cells), embolism (blood vessel blockage), or thrombosis (blood clot formation).
Healthcare providers should check affected dialysis catheters by lot number against the recall list. If a recalled catheter is identified, do not use it. Contact Covidien LP for replacement units or additional information about this recall. No injuries or illnesses have been reported related to this issue.
The recalled product
- Product
- MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 16 cm, Curved Extensions, Kit" REF: 8888345611
- Manufacturer
- Covidien LP
- Hazard
- obstruction
- embolism
- thrombosis
- hemolysis
Distribution
Distributed nationwide across the United States.
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