The article discusses the issue of medical device recalls by the FDA, highlighting a significant concern: many of these recalls do not result in the actual removal of the devices from use. Instead, the FDA and manufacturers often allow the devices to remain in use, sometimes with revised instructions or additional training for doctors.
One prominent example is Abbott’s MitraClip cardiac device, which had a Class I recall in 2016 due to the risk of serious injury or death. Despite this, the device was not removed from the market, and doctors continued to use it. Abbott updated the usage instructions and required further training for doctors instead of withdrawing the product. The article points out that this approach, which the FDA still considers a “recall,” might better be described as a “non-recall” since it does not remove potentially dangerous products from use.
The article raises questions about whether these actions are sufficient to protect the public, comparing the FDA’s approach to other agencies like the Consumer Product Safety Commission, which often mandates the removal of defective products. The FDA defends its decisions by citing the need to balance risks and benefits, especially when the devices in question are critical to patient care and have no immediate alternatives.
However, the article also presents cases where the continued use of recalled devices has led to adverse events, including deaths. For instance, Medtronic’s StealthStation S7 cranial software had a recall that left the device in use, despite potential risks like life-threatening injuries. Similarly, Abbott’s MitraClip has been subject to multiple recalls without removal, even after reports of malfunctions and deaths.
The article concludes by questioning whether the current system adequately protects patients and whether more stringent recall practices are needed.