Topic archive
MedTech Current publications and recall entries tagged Cardiovascular & Vital-Sign Monitoring.
The 9 October 2026 rule codifies a classification applicable since November 2023. Its seven groups of special controls connect sensor quality, clinical performance, alarms, usability and labelling; the device type remains subject to 510(k).
A leak during bypass requires a response in the circuit and to the equipment supporting it. Replacing the disposable heat exchanger does not resolve contamination of the heater-cooler; that equipment also needs removal from clinical use, decontamination, and inspection.
Health Canada has classified the recall of 10 specified Abiomed Automated Impella Controllers as Type I after a retrospective review found that the affected consoles had not received FCN 113 updates intended to prevent screen freezing and false controller errors during the Purge Cassette Change Wizard.
A structural failure involving a catheter component used during a transcatheter valve procedure can create immediate procedural disruption and retrieval concerns. The event is also relevant to cardiovascular-device manufacturers because a localized weld-control problem can trigger inventory identification and return activity across multiple clinical sites.
Inaccurate blood-pressure measurements can affect clinical assessment and treatment decisions, especially when the error is not obvious to the user. The field action is operationally important because facilities must verify the measurement method on affected devices and temporarily standardize use around the Step Deflation setting until the product correction is available.
The US FDA has issued a final order codifying cardiovascular machine learning-based notification software under 21 CFR 870.2380 as Class II (special controls), establishing a 510(k) pathway while excluding arrhythmia detection.
This event separates device sensing from downstream alert delivery: the implant may function as intended while server-side software delays the notification clinicians rely on. That makes the recall a useful example of how remote-monitoring infrastructure can create clinically meaningful risk without requiring replacement of the implanted device itself.
South Korea's MFDS has issued a new guide for evaluating the clinical accuracy of non-invasive automated blood pressure monitors, outlining auscultatory and invasive reference methods, subject and test-design requirements, analysis methods, and considerations for pregnant populations in alignment with ISO 81060-2.
Incorrect ECG waveforms or heart-rate values can affect clinical interpretation and therapeutic decisions, making this a high-relevance software correction. The event also shows why manufacturers need clear interim verification steps when a software defect can alter a displayed physiological signal before a corrected version is installed.
Loss of centralized monitoring and reset alarm settings can create immediate clinical and operational consequences, especially during a software update. The event is also a strong configuration-management example: a correction can introduce risk when patient-specific or care-area alarm settings do not persist as users expect.
FDA has classified the recall of Boston Scientific ENROUTE Transcarotid Neuroprotection System and ENROUTE Transcarotid Neuroprotection System Plus as Class I due to reports of arterial sheath tip separation during clinical use.