Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

NxStage Cartridge Express with Speedswap Recalled by NxStage MDS Corporation Due to Product is recalled due to reports of blood...

Date: January 29, 2024
Company: NxStage MDS Corporation
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact NxStage MDS Corporation directly.

Affected Products

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.

Quantity: 693

Why Was This Recalled?

Product is recalled due to reports of blood leaking or spraying from the arterial line on the cartridge.If this failure occurs, a patient may experience uncontrolled blood loss or a healthcare professional could be exposed to infectious patient blood.

Where Was This Sold?

This product was distributed to 19 states: AZ, CA, CO, GA, IL, IN, MD, MA, MI, MN, MS, MO, NJ, NY, NC, TN, TX, VA, WI

Affected (19 states)Not affected

About NxStage MDS Corporation

NxStage MDS Corporation has 1 total recall tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report