The Recall Desk
SevereFDA (Devices)·Z-2376-2023·Announced 2023-08-23

Mahurkar Dialysis Catheters Recalled for Center Lumen Obstruction

Covidien is recalling 1,099 MAHURKAR dialysis catheters worldwide due to excessive silicone lubricant that can block the center lumen, potentially delaying treatment.

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 requires a minimum rating of Severe (4). The obstruction can delay critical dialysis treatment and cause serious complications including embolism and thrombosis.

Plain-English summary

Covidien LP is recalling 1,099 MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter units (REF: 8888104003HP). The affected lot numbers are 2131200173, 2133700237, 2200400273, and 2200400290. These catheters were distributed nationwide and internationally.

The center lumen of these catheters was found to have an obstruction caused by excessive MDX, a silicone-based lubricant used to coat the catheter tip. This excessive buildup or uncured lubricant may dislodge or partially obstruct the catheter.

A fully or partially obstructed catheter can delay treatment or reduce blood flow during dialysis. If the silicone lubricant particles dislodge, they may enter the bloodstream and cause serious complications including hemolysis (destruction of red blood cells), embolism (blockage from debris), or thrombosis (blood clots). Dialysis centers should immediately stop using the affected lot numbers and contact Covidien for replacement units.

The recalled product

Product
MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Straight Extensions, PASS Tray REF: 8888104003HP
Manufacturer
Covidien LP
Hazard
  • catheter-obstruction
  • delayed-treatment
  • embolism
  • thrombosis
  • hemolysis

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: 20884521128054 LOT Numbers: 2131200173 2133700237 2200400273 2200400290

Distribution

Distributed nationwide across the United States.