Mahurkar Dialysis Catheters Recalled Due to Leaking Hub Defect
Covidien LP is recalling Mahurkar dialysis catheters for a potential leaking condition in the hub that may cause unanticipated fluid return during use. Over 359,000 units are affected worldwide.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The FDA classified this as a Class I recall, which requires a minimum severity score of 4 (Severe) per the recall rubric. Although the defect—a leaking condition in the device hub caused by an inter-lumen void—could result in serious patient harm, no illnesses or injuries have been reported.
Plain-English summary
Covidien LP is recalling multiple model numbers of the Mahurkar 13.5Fr High Flow Dual Lumen Acute Dialysis Catheter. These are single-use, sterile medical devices used for vascular access during acute dialysis treatment.
A potential leaking condition has been identified in the hub of affected devices. The condition results from an inter-lumen void in the hub component and may cause unanticipated fluid return during use.
Approximately 359,730 units are affected globally, including 23,003 units distributed in the United States and its territories, and 336,727 units distributed to more than 40 countries worldwide. The affected devices include multiple model numbers with specific lot and serial numbers as detailed in the FDA recall notice.
Healthcare providers and patients may reference the model and lot numbers provided in the FDA recall notice to identify potentially affected units.
The recalled product
- Product
- MAHURKAR 13.5Fr High Flow Dual Lumen Acute Dialysis Catheter, Sterile, Single Use, Rx Only: 13.5cm, Straight Extensions, Kit - Model No. 8888135131; 13.5 cm, Curved Extensions, Kit - Model No. 8888135132; 13.5cm, Pre-Curved, Kit - Model No. 8888135133; 13.5cm, Straight…
- Manufacturer
- Covidien LP
- Hazard
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 (2)
- Model no. 8888135131
- UDI-DI (GTIN) 20884521006208
Distribution
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