Agency classClass IIOur severity:High FDA (Devices)·Z-1026-2023·Announced 2023-02-08

Affinity Fusion Oxygenator adapter may loosen during cardiac surgery

Medtronic is recalling Affinity Fusion Oxygenators because the Temperature Monitoring Adapter may come loose during setup or disassembly of the heart-lung machine used in cardiac surgery. No injuries have been reported.

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 recall of critical cardiac surgery equipment where a component may loosen during procedures. Although no injuries or deaths are reported in the source, the risk-of-harm nature of equipment failure during open-heart surgery meets the rubric criterion for High severity.

Plain-English summary

Medtronic Perfusion Systems is recalling the Affinity Fusion Oxygenator with Integrated Arterial Filter (Model CB841), a device used in cardiopulmonary bypass during cardiac surgery. The recall affects approximately 4,462 units distributed worldwide.

The company has observed an upward trend in complaints where the Temperature Monitoring Adapter (TMA) has come loose from the oxygenator. This loosening occurred either during pre-procedure setup of the perfusion circuit or post-procedure during disassembly.

Healthcare facilities and cardiac surgery teams using affected equipment should review the serial number ranges (8111483548 through 8113999999) and lot numbers to determine if their units are included in the recall. Affected units should be removed from service. Hospitals should contact Medtronic for further instructions regarding remediation or replacement of affected devices.

The recalled product

Product: Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, Custom Packs, REF CB841. Used in Cardiopulmonary bypass.
Manufacturer: Medtronic Perfusion Systems
Category: Medical Device — Cardiac Surgery Equipment
Hazard: loose-adapter
equipment-failure
Affected units: 4,462

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 (20)

Model CB841
Serial Number Range: 8111483548 - 8113999999
GTIN Number: 00763000225452 (Lot Numbers: 13394614
13395228
223819363
223952969
224315522
224448403
224772847
224772848
224772849)
GTIN Number: 00763000225469 (Lot Numbers: 13392615
13394868
223476442
223755429
223796291
223834097
223834098
224174020
224188890

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 6 recalled by Medtronic Perfusion Systems under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 6 products in this recall →

Same manufacturer · Medtronic Perfusion Systems

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Same hazard · loose adapter