Invivo Recalls Xper Flex Cardio Physiomonitoring Systems Due to Communication Issues
Invivo Corporation is recalling 4,535 Xper Flex Cardio Physiomonitoring systems because of intermittent communication between the host system and the device.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any illnesses, injuries, or hospitalizations. The hazard is a functional defect (intermittent communication) without reported harm, fitting the criteria for a moderate severity score.
Plain-English summary
Invivo Corporation is recalling 4,535 units of the Xper Flex Cardio Physiomonitoring system. The recall is due to intermittent communication between the host system and the FlexCardio device. The affected products are Revision A and B units with specific code numbers listed in the recall notice.
The Xper Flex Cardio Physiomonitoring system is used to facilitate invasive investigations of heart and vascular disease when non-invasive indicators warrant such procedures. The recall covers devices distributed across the United States, Puerto Rico, and numerous international locations.
No specific instructions for consumers or healthcare providers are provided in the source text regarding immediate actions to take. Users should refer to the official FDA recall notice for further details on how to proceed.
The recalled product
- Product
- Xper Flex Cardio Physiomonitoring system. Used to facilitate invasive investigations of heart and vascular disease when non-invasive indicators warrant such.
- Manufacturer
- Invivo Corporation
- Hazard
- Affected units
- 4,535
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 (9)
- All Flex Cardio devices
- Revision A
- B Code Number's: 453564241901
- 453564241911
- 453564483321
- 453564483331
- 989803185601
- 9898031930191
- 860335 and 860338
Distribution
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