Agency classClass IIOur severity:High FDA (Devices)·Z-2092-2021·Announced 2021-07-28

Blood heater-cooler devices recalled for water contamination and infection risk

Gentherm's Hemotherm CE blood cooler/heater devices may harbor dangerous organisms including nontuberculous mycobacteria in their water systems that could aerosolize during cardiac surgery, risking patient infection.

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: The recall involves nontuberculous mycobacteria, a high-risk pathogen, in a Class II medical device used during cardiac surgery. However, no illnesses, injuries, or deaths have been reported. Per the severity rubric, high-risk pathogens without reported illness qualify for a High (3) rating.

Plain-English summary

Gentherm Medical, LLC has issued a Class II recall of the Hemotherm CE Dual Reservoir Cooler/Heater, Model 400CE, 115V Model (part no. 86022), used to cool or warm blood during cardiopulmonary bypass procedures in cardiac surgery.

The FDA identified a potential risk that organisms, including nontuberculous mycobacteria (NTM), can grow in the water systems of the heater-cooler device. During surgery, water contaminated with these organisms could aerosolize in the operating room, potentially exposing patients to infection through respiratory inhalation.

The recall affects 1,448 devices worldwide: 1,010 units in the United States (including Puerto Rico) and 438 units distributed internationally to Argentina, Bangladesh, Chile, Colombia, France, Guatemala, Hungary, India, Indonesia, Israel, Italy, Nepal, Nigeria, Pakistan, Philippines, Romania, Saudi Arabia, Singapore, South Africa, South Korea, Switzerland, Taiwan, Thailand, Turkey, and the United Arab Emirates. All units with serial numbers from 092-10011CE through 212-11499CE are included in the recall.

The recalled product

Product: Hemotherm CE Dual Reservoir Cooler/Heater, Model 400CE, 115V Model, part no. 86022. Used to cool or warm blood during cardiopulmonary bypass procedures
Manufacturer: Gentherm Medical, LLC
Category: Medical Device — Cardiopulmonary Bypass Equipment
Hazard: ntm
water-contamination
infection-risk
aerosolization

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 (1)

All units in service life Serial Numbers: 092-10011CE tot 212-11499CE

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Same manufacturer · Gentherm Medical, LLC

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