Invivo Xper Flex Cardio Physiomonitoring System Recalled for Inaccurate Pressure Readings
Invivo is recalling 4,375 Xper Flex Cardio Physiomonitoring Systems because ventricular end-diastolic pressure readings may be inaccurate. The issue affects specific model numbers used in cardiac catheterization rooms.
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 a medical device used in invasive cardiac procedures where inaccurate pressure readings could lead to clinical mismanagement. This fits the 'High' severity criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Invivo Corporation is recalling 4,375 units of the Philips Xper Flex Cardio Physiomonitoring System. The affected model numbers are 453564241901, 453564483321, 453564621791, and 989803199561 (international only). These devices are used to facilitate invasive investigation of heart and vascular disease when non-invasive indicators warrant such procedures.
The recall is due to a potential inaccuracy in the real-time numeric value for ventricular end-diastolic pressure (EDP) displayed on the Live Display. Because ventricular pressure monitoring is only performed in the cardiac catheterization procedure room using the FC2010 device, the FC2020 device, which is used in Pre or Post-Op Holding Areas, is not impacted by this issue.
The affected units were distributed worldwide, including the United States (nationwide, including Puerto Rico) and numerous international countries. Healthcare providers using these devices should verify their model and serial numbers against the recall list and contact Invivo Corporation for further instructions.
The recalled product
- Product
- PHILIPS Xper Flex Cardio Physiomonitoring System, Model Numbers: 453564241901, 453564483321, 453564621791, and 989803199561 (international only) The Xper Flex Cardio physiomonitoring system is used to facilitate invasive investigation of heart and vascular, disease when…
- Manufacturer
- Invivo Corporation
- Hazard
- Affected units
- 4,375
Distribution
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