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
- Affected units
- 1,099
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.
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
Same manufacturer · Covidien LP
See all →- SevereDermalon Sutures Recalled for Potential Sterile Barrier Packaging Defects
FDA (Devices) · 2026-08-19
- HighV-Loc 180 Absorbable Wound Closure Device Recalled for Packaging Defects
FDA (Devices) · 2026-08-19
- SevereSurgipro II Sutures Recalled for Potential Sterile Barrier Defects
FDA (Devices) · 2026-08-19
- HighV-Loc 90 Absorbable Wound Closure Devices Recalled for Packaging Defects
FDA (Devices) · 2026-08-19
- HighSurgipro Sutures Recalled for Potential Sterile Barrier Perforation
FDA (Devices) · 2026-08-19
Same hazard · catheter obstruction
See all →- SevereDialysis catheter recall: excessive lubricant causes center lumen obstruction
FDA (Devices) · 2023-08-23
- SevereDialysis Catheter Recalled Due to Silicone Lubricant Obstruction Risk
FDA (Devices) · 2023-08-23
- SevereFDA Recalls Mahurkar Dialysis Catheter for Potential Tip Obstruction Risk
FDA (Devices) · 2023-08-23
- SevereDialysis catheters recalled for potential center lumen obstruction
FDA (Devices) · 2023-08-23
- SevereDialysis Catheter Recalled for Center Lumen Occlusion Risk
FDA (Devices) · 2023-08-23