Medtronic Affinity Fusion Oxygenator: Temperature Monitoring Adapter May Detach
Medtronic is recalling 2,937 Affinity Fusion Oxygenators used in cardiac surgery because the Temperature Monitoring Adapter may detach during setup or disassembly.
What this means for you
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: FDA Class II medical device recall for a component of a device used in critical cardiopulmonary bypass procedures. The detached Temperature Monitoring Adapter is a real failure with an upward trend of complaints, but no injuries or illnesses are reported in the source. This meets the rubric criterion for risk-of-harm products where injury has not yet been reported, warranting a High rating.
Plain-English summary
Medtronic Perfusion Systems is recalling 2,937 units of the Affinity Fusion Oxygenator (Model BB811), a medical device used in cardiopulmonary bypass surgery. The recall affects units distributed worldwide.
The company has received an increasing number of reports that the Temperature Monitoring Adapter (TMA) attached to the oxygenator has come loose from the device. This loosening can occur either during pre-procedure setup of the perfusion circuit or during post-procedure disassembly. A loose adapter could affect the temperature monitoring function during cardiopulmonary bypass procedures.
Affected lot and serial number ranges have been identified by the manufacturer. Healthcare facilities using this device should determine whether they have affected units by comparing their device serial numbers and lot numbers against the recall information and contact Medtronic with questions or if they are affected.
The recalled product
- Product
- Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, Custom Packs, REF BB811. Used in Cardiopulmonary bypass.
- Manufacturer
- Medtronic Perfusion Systems
- Hazard
- component-detachment
- temperature-monitoring-failure
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 BB811
- Serial Number Range: 8111483548 - 8113999999
- GTIN Number: 00643169178168 (Lot Numbers: 13386860
- 13386998
- 13387454
- 223834103
- 224773022
- 224773023
- 225467084
- 225467085)
- GTIN Number: 00643169178175 (Lot Number: 13388339
- 13389098
- 13394289
- 223815345
- 223829391
- 223834104
- 223834105
- 224602715
- 224695594
- 224702830
Distribution
Distributed nationwide across the United States.
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