For other agencies, recalls mean removing products from the market, but with FDA medical device recalls, products are often allowed to stay in the market, CBS News reported Aug. 13.
These "non-recalls" have been happening for years with a number of medical devices, some of which have led to adverse events and patient deaths. For medical devices, recalls include not only removals, but corrections, which address the problem in the field, such as repairing, adjusting, relabeling or inspecting a device.
From 2019 to 2023, there were 338 Class I medical device recalls, 164 of which were corrections and 174 were removals, FDA spokesperson Amanda Hils told CBS.
In some cases, medical devices subject to a recall can be kept on the market safely with a simple fix, but in other cases, medical products undergo recall after recall while remaining in use on the market.
"When deciding whether a recall warrants device removal from the field, the FDA considers the frequency and severity of adverse events, effectiveness of the corrective actions that have been executed, and the benefits and risks of preserving patient access to the device," FDA spokesperson Audra Harrison told CBS.
The FDA reviews the recall strategies that manufacturers propose and provides input to ensure the public will be protected, Ms. Hils said. The agency also monitors the effectiveness of recalls and ensures the strategy is carried out.
In cases of product removals, many patients will not have the device removed from their body due to the risk of removal compared with leaving it in place.
However, some products have come under scrutiny after facing multiple recalls. For example, in 2016, Abbott and the FDA issued a recall for its MitraClip cardiac device due to risk of serious injuries or death. But neither organization removed the device from the market or suspended its use. Rather, Abbott revised instructions for use and required physicians who implanted the clips to undergo training. Since then, the device has undergone three recalls, none of which removed the product.