More of the moment news concerning medical device recalls is appearing in the headlines. We checked the ‘Predicting Recalls Model’ and yes, more current recalls are scoring a ‘1’ in the model, meaning they were predicted.
Boston Scientific Recalls INGENIO Family of Pacemakers and CRT-Ps Due to Risk of Transition to Safety Mode
Details of the recall involving the INGENIO family of pacemakers and CRT-can be found on the FDA website. Issues have been reported with the product transition to safety mode.
There have been 65 reported incidents, including three injuries which required patients to receive temporary external pacing. There have been no reports of death.
Medtronic Stops Distribution and Sale of HeartWare HVAD System Due to Risk of Neurological Adverse Events, Mortality, and Potential Failure to Restart
In the recall details of the HeartWare HVAD system, the company initiated the recall June 3, 2021 with 4,620 devices recalled in the US to date. More details can be found on the FDA website.
In both cases, the Predicting Recalls Model scored these products as highly likely for recall at multiple time points.
Medtronic Recalls Pipeline Flex Embolization Devices for Risk of Delivery System Fractures During Placement, Retrieval, or Movement of Device
FDA released information concerning the recall of this product on September 22, 2021. The Pipeline Flex Embolization Device and Pipeline Flex Embolization Device with Shield Technology are permanent mesh cylinders (stent) braided from platinum and tungsten and cobalt-chromium-nickel alloy wires. These devices are intended for the treatment of brain aneurysms that bulge or balloon out the sides of the blood vessel (wide-neck and fusiform). The Pipeline Flex Devices include a guidewire-based delivery system used to place the implant inside the patient.
Medtronic (Micro Therapeutics, Inc. d/b/a ev3 Neurovascular) is recalling the Pipeline Flex Embolization Device and Pipeline Flex Embolization Device with Shield Technology because there is a risk of the delivery system’s wire and tubes fracturing and breaking off when the system is being used to place, retrieve, or move the stent inside a patient. In the United States (U.S.), the recall is only limited to the Pipeline Flex Embolization Device. Outside the U.S., the recall applies to both the Pipeline Flex Embolization Device and the Pipeline Flex Embolization Device with Shield Technology.
Fractured pieces could be left inside the patient’s brain bloodstream. It is also possible that attempts to retrieve the fractured pieces may make the patient’s condition worse. The fragments can also cause other serious adverse health consequences such as continued blockage of blood vessels, stroke, and death.
There have been 59 reported device malfunctions, 10 serious injuries, and two deaths related to this recall.
In the Prediction Recall Model, this product was identified with an ID of 2125 and scored as having a high probability of recall based on the public data. According to the input data, we see that leading up to the prediction the product has a significant number of Adverse Events (AE).
See the full information concerning this recall on the FDA website.
Using publicly available data and a machine-learning algorithm, we are seeing some startling results from the model.
With the insights provided by the model, we believe many stakeholders can make better decisions that improve patient safety, mitigate reputational risks, improve product quality, make better financial decisions and guide policy decisions.
These are more examples of how the multi-iterative, criteria-driven model has shown directionally to predict medical device recalls. Specialty categories have yielded the most interesting results.
What is the basis of the source data? The historical data from FDA and other public sources has been normalized, aggregated and forms the core analytical database of Reed Tech Navigator™ for Medical Devices.
The results are encouraging, creating additional possibilities for the many use cases that are solved utilizing the source database, Navigator™ for Medical Devices.