MEDICAL DEVICE RECALLS IN CANADA FROM 2005 TO 2015
Anna R Gagliardi1, Julie Takata1, Ariel Ducey2
1Division of Support Systems and Outcomes,Toronto General Hospital Research Institute.
Objectives:
Medical devices are ubiquitous in modern medical care. However, little is known about the epidemiology of medical devices in the healthcare marketplace, including the rate at which medical devices are subject to recalls or other advisories. We sought to study the epidemiology of medical devices in Canada, focusing on device recalls. In Canada, a recall may signify a variety of events, ranging from relatively minor field safety notifications, to removal of a product from the marketplace.
Methods:
We used data from Health Canada to study medical device recalls in Canada from 2005 to 2015. We analyzed the risks of medical device recalls according to the risk class of the device (I lowest; IV highest) and the hazard priority of the recall (Type I highest potential harm; Type III lowest potential harm).
Results:
During a 10-year period, there were 7,226 medical device recalls. Most recalls were for intermediate risk class (Class II, 40.1 percent; Class III, 38.7 percent) medical devices. Among recalled devices, 5.0 percent were judged to have a reasonable probability of serious adverse health consequences or death (Type I recall Hazard Priority classification). While the number of medical devices marketed in Canada is not known, over a similar 10-year period, 24,849 new Class II, II, and IV medical device licenses were issued by Health Canada.
Conclusions:
Several hundred medical device recalls occur in Canada each year. Further research is needed to characterize the nature of medical device recalls, and to explore how consumers use information about recalls.
Insights
Over 7,000 medical device recalls occurred in Canada between 2005 and 2015, with most involving intermediate-risk devices. A small percentage of recalls were high-risk, indicating potential serious harm.
Area of Science:
- Medical Device Safety
- Public Health Surveillance
- Epidemiology
Background:
- Medical devices are essential in healthcare, yet data on their market epidemiology, including recall rates, is limited.
- Understanding medical device recalls is crucial for patient safety and regulatory oversight.
Purpose of the Study:
- To investigate the epidemiology of medical device recalls in Canada from 2005 to 2015.
- To analyze recall risks based on device classification and hazard priority.
Main Methods:
- Utilized Health Canada data spanning a 10-year period (2005-2015).
- Analyzed medical device recalls by risk class (I-IV) and recall hazard priority (Type I-III).
Main Results:
- A total of 7,226 medical device recalls were recorded.
- The majority of recalls involved intermediate-risk devices (Class II and III).
- Approximately 5.0% of recalled devices were classified as Type I, indicating a high probability of serious adverse health consequences or death.
Conclusions:
- Hundreds of medical device recalls occur annually in Canada.
- Further research is necessary to understand the characteristics of these recalls and consumer engagement with recall information.
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