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# FDA, Industry Should Better Manage Device Recalls: Study
- URL: https://www.fdaweb.com/fda-industry-should-better-manage-device-recalls-study/
- Published: 2020-01-08T12:00:00.000Z
- Updated: 2026-09-14T15:57:46.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5145796

Minneapolis Heart Institute researchers say that FDA and the medical device industry need to improve the way they manage medical device recalls. Writing in *JAMA Internal Medicine*, the researchers [say](https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/2757529?ref=fdaweb.com) that their study of patients implanted with a defective Medtronic InSync pacemaker showed that the pacemaker recall was delayed and that the subsequent communications did not include all critical information needed for safe and effective patient care.

The authors say their clinical experience and the results of their analysis of the MAUDE (Manufacturer and User Facility Device Experience) database suggest that neither Medtronic nor FDA comprehended the clinical risks posed by the pacemaker’s defects. They say their conclusion is supported by their findings that: 

- the manufacturer and FDA were aware of a pacemaker battery problem and its clinical consequences for at least 19 months before the units were recalled;
- doctors and patients were never informed of a lifted bond wire (electrical interconnect) problem;
- doctors were not informed that interrogating or programming the pacemaker could result in abrupt loss of pacing;
- no meaningful product updates were issued by Medtronic or mandated by FDA subsequent to the recall, even though the number of failures increased after the recall; and
- FDA classified the recall as Class 2 (no immediate danger of death or serious injury) rather than Class 1 (significant risk of death or serious injury) and did not change it despite adverse event reports.

“Timely notification of medical device defects is necessary to limit the exposure of patients to products that are unreliable and/or pose a notable health risk,” the authors conclude. “Methods exist that can identify device issues earlier than the passive surveillance system currently used by FDA…. We suggest that similar safety monitoring tools should be adopted by the medical device industry and encouraged by FDA. We further suggest that the industry and FDA review their processes for informing patients and physicians of critical device performance issues, especially for vulnerable populations who depend on their devices for life-sustaining therapy.”

Asked for a comment, an FDA spokesperson said: "In general, FDA does not comment on specific studies, but evaluates them as part of the body of evidence to further our understanding about a particular issue and assist in our mission to protect public health. FDA is reviewing the findings of the paper. As additional background – FDA takes seriously its responsibility to monitor device safety and performance, take action when needed, and help ensure patients and providers have the information they need to make informed healthcare decisions. In our April 2018 [Medical Device Safety Action Plan](https://www.fda.gov/about-fda/cdrh-reports/medical-device-safety-action-plan-protecting-patients-promoting-public-health?ref=fdaweb.com) we described several of the key actions we had taken in the past and steps we planned to take in the future. Since then we have been implementing the plan and have continued to enhance postmarket surveillance capabilities generally through several efforts, including enforcement of adverse event reporting requirements, improved summary reporting with public transparency, reorganization to share expertise and responsibility across pre- and postmarket activities, and support for the establishment of a National Evaluation System for health Technology (NEST) led by the Medical Device Innovation Consortium (MDIC). We are also in the process of a digital transformation to build a modern platform that will allow us to make more information readily available and easier to access analyze by the public. FDA remains committed to these ongoing improvements to enhance device safety."