The Recall Desk
SevereFDA (Devices)·Z-2379-2023·Announced 2023-08-23

Dialysis Catheters Recalled Due to Excessive Lubricant Causing Obstruction

Covidien is recalling MAHURKAR dialysis catheters that may have excessive lubricant coating the catheter tip, potentially causing dangerous blockages that delay treatment or lead to serious complications.

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: FDA Class I classification applies to this recall. The hazard—excessive silicone lubricant causing catheter obstruction—could result in delayed dialysis treatment or serious medical complications including hemolysis and thromboembolism, though no illnesses have yet been reported.

Plain-English summary

Covidien LP is recalling approximately 7,293 units of MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheters (REF: 8888340629HP). The catheters have 20 cm straight extensions and were distributed nationwide and internationally.

The center lumen of affected catheters contains excessive MDX, a silicone-based lubricant coating the catheter tip. This excess coating may partially or fully obstruct the catheter lumen, or dislodge and cause blockages within the catheter.

Obstructed catheters can delay dialysis treatment and reduce blood flow. Possible serious complications include hemolysis, embolism, or thrombosis. Affected patients and healthcare providers should discontinue use of the affected lot numbers and contact their supplier for replacements. The recall includes 13 specific lot numbers spanning from 1926100313 to 2230400227.

The recalled product

Product
MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Straight Extensions, Kit REF: 8888340629HP
Manufacturer
Covidien LP
Hazard
  • catheter-obstruction
  • hemolysis
  • embolism
  • thrombosis

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • GTIN: 10884521128071

Distribution

Distributed nationwide across the United States.