Dialysis Accessory Device Recalled for Blood Leakage Risk
The NxStage Cartridge Express dialysis device is recalled because blood can leak or spray from the arterial line. This could cause uncontrolled blood loss in patients or expose healthcare workers to infectious blood.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II medical device with a documented failure mode (blood leaking or spraying) that poses serious risk of harm—uncontrolled blood loss in patients and bloodborne pathogen exposure for healthcare workers. However, no hospitalizations or injuries are reported in the source text, meeting the criteria for High severity: risk-of-harm products where injury has not yet been reported.
Plain-English summary
The NxStage Cartridge Express with Speedswap (Catalog No. CAR-535) is a dialysis device accessory used to remove and replace filters in the treatment of acute or chronic kidney failure or fluid overload. The manufacturer, NxStage MDS Corporation, has recalled 693 units distributed to dialysis centers across 19 U.S. states.
The recall was initiated due to reports of blood leaking or spraying from the arterial line connection on the cartridge. This equipment failure could result in uncontrolled blood loss in patients or expose healthcare workers to infectious patient blood.
Affected units can be identified by the following lot numbers: 20878001, 30978013, 30978032, 31178011, and 31178019.
The recalled product
- Product
- NxStage Cartridge Express with Speedswap, Catalog No. CAR-535. An accessory device for facilitating the removal and replacement of a flow-compromised filter during treatment of acute and chronic renal failure or fluid overload.
- Manufacturer
- NxStage MDS Corporation
- Affected units
- 693
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 (6)
- UDI-DI M535CAR5350
- Package DI M535CAR5355 Lots 20878001
- 30978013
- 30978032
- 31178011
- 31178019
Distribution
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