Class I — Serious Health Hazard

Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.

FLOW-i Anesthesia System The FLOW-i Anesthesia System is intended for Recalled by Maquet Cardiovascular Us Sales, Llc Due to In some Flow-i Anesthesia Systems, patient cassette can...

Date: April 2, 2015
Company: Maquet Cardiovascular Us Sales, Llc
Status: Terminated
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 Maquet Cardiovascular Us Sales, Llc directly.

Affected Products

FLOW-i Anesthesia System The FLOW-i Anesthesia System is intended for use administering inhalation anesthesia on neonatal to adult patient populations.

Quantity: 1641 [80 units (US) 1561 units (OUS)]

Why Was This Recalled?

In some Flow-i Anesthesia Systems, patient cassette can get dislodged which could result in gas leakage within the system internal circuit potentially leading to a stop in ventilation.

Where Was This Sold?

This product was distributed to 12 states: AL, AZ, FL, MI, MO, NJ, NY, OR, PA, TX, WV, DC

Affected (12 states)Not affected

About Maquet Cardiovascular Us Sales, Llc

Maquet Cardiovascular Us Sales, Llc has 62 total recalls tracked by RecallDetector.

Related Recalls

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