Agency classClass IIOur severity:High FDA (Devices)·Z-0531-2015·Announced 2014-12-17

Medtronic Recalls Affinity Fusion Oxygenators Due to Damaged Heat Exchangers

Medtronic Perfusion Systems is recalling 168 Affinity Fusion Oxygenators with Carmeda Bioactive Surface due to damaged heat exchangers.

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 is classified as FDA Class II, and the hazard involves a structural defect (damaged heat exchangers) in a critical medical device used for gas exchange, posing a risk of harm without reported fatalities.

Plain-English summary

Medtronic Perfusion Systems has initiated an urgent medical device recall for Affinity Fusion Oxygenation Systems with Carmeda Bioactive Surface. The recall was initially issued for 66 distributed devices and has been updated to include 168 additional devices, affecting a total of 234 units. The affected product is limited to model CB841, which may be sold standalone or incorporated in Total Systems TS1614R1 and TS1595R7.

The recall is due to damaged heat exchangers in the devices. The Affinity Fusion Oxygenator is a single-use, microporous, hollow-fiber, gas-exchange device with an integrated heat exchanger and arterial filter. It is designed to reduce platelet activation and adhesion while preserving platelet function.

The affected devices were distributed in the United States to California and Florida, as well as internationally to the Czech Republic and Switzerland. Specific lot numbers and serial numbers are listed in the official recall documentation. Healthcare providers and patients should contact Medtronic Perfusion Systems for further instructions on how to proceed with the recall.

The recalled product

Product: The Affinity Fusion Oxygenator with Integrated Arterial Filter and Carmeda Bioactive Surface is a single-use, microporous, hollow-fiber, gas-exchange device with plasma resistant fiber and integrated heat exchanger and arterial filter. The oxygenator is bonded on its primary…
Manufacturer: Medtronic Perfusion Systems
Category: Medical Device — Cardiovascular / Perfusion
Hazard: structural-defect
damaged-heat-exchanger

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)

13 (serial # 8110141520)
13023057 (Serial # 8110141435 and 8110141539).

Distribution

Distributed in 2 states:

Same manufacturer · Medtronic Perfusion Systems

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Same hazard · structural defect