The FDA announced on Dec. 7, 2022, that Covidien LP is recalling MAHURKAR dialysis catheters due to a potential leaking condition in the hub that may cause unanticipated fluid return during use. The agency issued recall number Z-0877-2023 for the Class I device.
How to tell if you have it
- Brand: Covidien
- Product: MAHURKAR 13.5Fr High Flow Dual Lumen Acute Dialysis Catheter, Sterile, Single Use, Rx Only
- Model No. 8888135131 (13.5cm, Straight Extensions, Kit)
- Model No. 8888135132 (13.5 cm, Curved Extensions, Kit)
- Model No. 8888135133 (13.5cm, Pre-Curved, Kit)
- Model No. 8888135134 (13.5cm, Straight Extensions, IC Tray)
- Model No. 8888135161 (16cm, Straight Extensions, Kit)
- Model No. 8888135162 (16cm, Curved Extensions, Kit)
- Model No. 8888135163 (16 cm, Pre-Curved, Kit)
- Model No. 8888135164 (16cm, Straight Extensions, IC Tray)
- Model No. 8888135191 (19.5cm, Straight Extensions, Kit)
- Model No. 8888135192 (19.5cm, Curved Extensions, Kit)
- Model No. 8888135193 (19.5cm, Pre-Curved, Kit)
- Model No. 8888135194 (19.5cm, Straight Extensions, IC Tray)
- Model No. 8888135198 (19.5cm, Curved Extensions, PASS Tray)
- Model No. 8888135241 (24cm, Straight Extensions, Kit)
- Model No. 8888135242 (24cm, Curved Extensions, Kit)
- Model No. 8888135243 (24cm, Pre-Curved, Kit)
- Distribution: Worldwide including US nationwide and Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Costa Rica, Czech Republic, Denmark, Dominican Republic, Ecuador, Finland, France, French Polynesia, Germany, Greece, Hungary, Iceland, Italy, Jamaica, Kenya, Malaysia, Malta, Mauritius, Mexico, Nicaragua, Norway, Oman, Panama, Peru, Philippines, Poland, Portugal, Romania, Russian Federation, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Trinidad And Tobago, Tunisia, Turkey, Uganda, United Arab Emirates, and United Kingdom
The hazard
According to the FDA, there is a potential leaking condition within the hub of affected devices due to an inter-lumen void in the hub component. This defect may result in unanticipated fluid return during use.
Context
GovInfoNow's records show Covidien, LP has 26 other recalls on record since July 17, 2017. Other recent recalls of similar products include Merit Medical DuraMax Hemodialysis Catheter Recall (Feb. 13, 2026), Merit Medical Systems CentrosFLO Hemodialysis Catheters Recall (Feb. 13, 2026), and Merit Medical ProGuide Dialysis Catheters Recall (Feb. 13, 2026).