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Baxter is issuing an important product information letter to communicate that the cardiovascular surgery marketing brochure (Ref ca-as32-210022 (English) and ca-as32-220004 (French)) that was distributed for the products listed above contains inaccurate…

Baxter is issuing an important product information letter to communicate that the cardiovascular surgery marketing brochure (Ref ca-as32-210022 (English) and ca-as32-220004 (French)) that was distributed for the products listed above contains inaccurate…

Maquet Cardiopulmonary Gmbh received customer complaints for custom tubing packs (CTP) reporting the perforation of the Tyvek, the upper part of the sterile barrier of the packaging. Upon further investigation, the internal components set were found to…

In rare cases, an ECG failure affecting impedance measurement via defibrillation electrodes has led to the Defigard Touch-7 falsely reports an electrode fault, resulting in inoperative defibrillation. Recall start date: November 14, 2023

Medtronic is notifying customers of a population of LINQ II Insertable Cardiac Monitors (ICM) that underwent a manufacturing process that may allow for moisture to impact electrode performance. This may create the potential for amplified noise and/or…

Stryker Canada has identified an increase in number of complaints related to LP15 ACPA failures with the reported symptoms of "battery not charging" and "auxiliary power will not power device or charge batteries". This issue is only applicable to ACPAs…

Philips has identified a potential safety and compliance issue: the HeartStart Intrepid Monitor/Defibrillator's service manual does not detail electrical safety test verification methods as required by International Electrotechnical Commission(IEC)…

There is a risk that the positioner arm may not tighten or lock during normal use. Recall Start Date: November 3, 2023

As a result of an investigation of Safe-T-Vue 10 lot # s10061923, the manufacturer, Temptime Corporation, has identified an error during label printing. This has caused a small percentage of box labels to display an incorrect lot #. Instead of the…

Abbott recently observed an increase of reports (complaints) in which the power connector plug became frayed or damaged over time. Damage and fraying of the power connector plug can occur with repeated bending or manipulation beyond 90 degrees. Fraying…

Boston Scientific Corporation (BSC) is initiating a product advisory notification for the Emblem S-ICD pulse generator and Emblem MRI S-ICD pg to inform customers that a software update for the Emblem S-ICD is available to correct the potential for a…

Boston Scientific Corporation is initiating a product advisory to inform customers of the increased potential for J-tipped mechanical guidewires packaged from 10 March to 28 July 2023 within the Baylis Medical Company Versacross Connect LAAC Access…

Atrium/Getinge is initiating a voluntary medical device recall/removal for the Advanta V12 covered stent system due to an identified manufacturing deficiency that may cause a loss of balloon pressure or inability to hold balloon pressure during Advanta…

Abott is informing customers of a rare potential for a bluetooth circuit component issue on subset of Neturino Implantable Cardioverter Defrbrillators (ICDs) and Cardiac Resynchronization Therapy Defribrilators (CRT-Ds) manufactured prior to April 2022.…

Starting in April 2023, Abbott has received complaints regarding inability of the Apical Coring Knife to start and/or complete resecting heart tissue when the physician was preparing the patient's heart for implantation of the left ventricular assist…