Each year, the US Food and Drug Administration (FDA) designates anywhere from dozen to hundreds of medical device recalls as Class I, indicating that the risk addressed by the recall could potentially cause serious injury or death.

But it can be difficult to quantify the number of device recalls in a year, given the multiple data sources from FDA, including a listing of annual Class I and other significant recalls, a device recalls database and a data dashboard.

Background

Medical device recalls involve a removal or a correction to a marketed device to address a risk or a defect in the device.

Most device recalls do not require patients to stop using an affected device or require the device to be returned to the manufacturer. Instead, recalls often involve other steps, such as an inspection of the device, a repair, updating the device software or firmware, notifying patients and physicians of new labeling or alerting them to a potential risk.

Device makers are legally required to notify FDA of any corrections or removal actions. FDA then reviews the company's proposed strategy for carrying out the correction or removal, and assigns the recall a risk classification:

• Class I: A situation where there is a reasonable chance that a product will cause serious health problems or death;
• Class II: A situation 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;
• Class III: A situation where a product is not likely to cause any health problem or injury.

While the vast majority of recalls are initiated voluntarily by device manufacturers, FDA has the authority to require a company to recall a violative device.

2017 Recalls

The number of device recalls has climbed steadily from 2,303 in FY2013 to 3,202 in FY2017.

But the vast majority of all device recalls are Class II recalls, which account for nearly all of the growth in total recalls across those years.

For calendar year 2017, FDA lists 32 Class I medical device recalls in its annual recall list, which is comparable to the 39 recalls listed for 2016 and 32 in 2015, but still lower than the 60 and 62 recalls reported in 2014 and 2013.

These lists mostly feature Class I recalls and some Class II and III recalls that may be of heightened interest to patients.

But the number of recalls featured in these lists differ significantly from the numbers shown in FDA's medical device recalls database, as some Class I recalls are not included in the annual lists and some of the entries on the list account for more than one database entry when the recall affects multiple models made by a company.

For instance, in 2017, Abbott Vascular initiated a recall of 590 units of its Absorb Bioresorbable Vascular Scaffold (BVS) systems distributed to Australia that was classified as a Class I recall by FDA. While this recall appears in FDA's database, it is not in the agency's annual list, presumably because the recall only affected units distributed in Australia.

With those factors in mind, the raw number of Class I recall entries in FDA's recall database are 52 in 2017, 117 in 2016, 77 in 2015, 557 in 2014 and 176 in 2013. But looking closer at the spike in results for 2014, 412 of the Class I recalls that year were part of a large packaging-related recall for devices made by Customed, Inc.

New in 2017

In January 2017, CDRH began providing information on recalls in its searchable database earlier than it did in the past by posting recall information at the time a firm takes a corrective or removal action and notifies the agency that it can post the information, rather than at the time FDA classifies the recall as Class I, II or III.

2017 was also notable in that it marked the first time a medical device was recalled in the US due to a cybersecurity concern. In August 2017, Abbott announced it was voluntarily recalling 465,000 pacemakers to install a firmware patch to address cybersecurity vulnerabilities identified in six of its pacemakers and implantable cardioverter defibrillators (ICDs).