Measures to Manage a Range of Recall Types

KEY POINTS

In the medical device industry, the term “recall” has a broad meaning that is different than how the term is used with consumer products.
The FDA classifies recalls into three categories: (1) Class I, where there is a reasonable chance that a product will cause serious health problems or death; (2) Class II, where a product may cause a temporary or reversible health problem or where there is a slight chance that it will cause serious health problems or death; and (3) Class III, where a product is not likely to cause any health problem or injury.
Medtronic is committed to maintaining robust Quality Systems that support development, manufacture, and distribution of high quality products that meet the expectations of healthcare practitioners and patients.
When Medtronic determines that a recall is necessary, we communicate with impacted healthcare practitioners and/or patients and provide recommendations to address the issue. Medtronic also informs FDA and other regulators of the action in accordance with applicable regulatory requirements.

Overview

In the Medical Device Industry, “Recall” Has a Broad Meaning

With medical devices, the term “recall” does not have the same meaning as it does in the consumer product context. In the medical device industry, the term “recall” is used generally to cover a range of actions, many of which do not involve product retrieval or market withdrawal. The FDA explains that “[a] medical device recall does not always mean that you stop using the product or return it to the company,” and a recall can include “inspecting the device for problems,” “adjusting settings on the device,” and “re-labeling the device.”¹ Some communications to customers about new risk information or labeling updates may be classified as a “recall.” For example, in May 2017, Medtronic notified customers using a specific insulin pump of a potential hardware issue that can result from rapid changes in atmospheric pressure, such as in flight during take-off or landing, and provided instructions to address this rare issue if it occurred. The product remained in the customers’ hands but the communication enabled correction of any potential situation. As this example demonstrates, a “recall” is not synonymous with product removal, nor can one infer from the occurrence of a recall that a device is defective or dangerous.

Recalls Can Be Classified by Risk

Not all recalls include the same level of risk. In the US, for example, the FDA classifies recalls into one of three categories: (1) Class I, where there is a reasonable chance that a product will cause serious health problems or death; (2) Class II, where a product may cause a temporary or reversible health problem or where there is a slight chance that it will cause serious health problems or death; and (3) Class III, where a product is not likely to cause any health problem or injury.

Medtronic’s Commitment to Robust Quality Control

Medtronic is committed to maintaining robust Quality Systems that support development, manufacture, and distribution of high quality products that meet the expectations of healthcare practitioners and patients. However, we also use a variety of post-market surveillance activities to identify circumstances where a marketed device may not be performing as expected and action may be needed. In some cases, Medtronic may determine that a recall is necessary.

When Medtronic determines that a recall is necessary, we communicate with impacted healthcare practitioners and/or patients and provide recommendations to address the issue. Medtronic also informs FDA and other regulators of the action in accordance with applicable regulatory requirements. Depending on the country, regulators may take additional steps such as classifying the recall action based on risk.

In some instances, a recall in one country may not occur in other countries, or recalls may vary from one country to another. This is due to various factors, all of which Medtronic reviews carefully in making recall decisions. For example, the scope of a recall may be related to a specific subset of devices (e.g., a specific lot), which may not have been distributed across all countries or regions. In other cases, the recall action may be unrelated to safety and instead relate to a compliance requirement that is unique to one or more countries. A recall can also be related to a particular indication, which may vary by jurisdiction depending on device labeling. Additionally, in some cases, a recall may relate to a country-specific procedural practice that necessitates a specific corrective action (e.g., an instruction to local health care providers regarding use of a specific device in a particular manner). While we continue to strive to minimize the number of recalls related to our products, we are proud of our safety record and the systems we have in place to detect, address, correct and communicate these issues when they do arise.