In a recent report by the GAO, it reported that between 2005 and 2009, 3510 recalls were initiated by medical device firms - an average of ~700 per year. Most of these recalls were Class II and involved Cardiovascular and Radiological devices. In fact, there were 532 Cardiovascular recalls during this time (15% of all recalls) and number of Class I recalls for this category was 31% of total Class I recalls. The largest number for Cardiovascular devices involved automatic external defibrillators.
The top reason for recalls in 2008 and 2009 was related to production/manufacturing processes. Here are the top 3 root causes in 2008 and 2009 for medical device recalls:
1. Process Control
2. Device Design
3. Component design/selection
Interestingly, in the "additional root causes"category (36% of all Class I recalls), all recalls related to label/labeling was in that bucket. In my experience with medical device companies, enterprise label management is a big challenge and can create major recalls for minor label/labeling errors.
Out of 101 Class I recalls, 74 of the recalls (73%) were for devices through the 510(K) process, 22% were for PMA. The report highlights that FDA has not analyzed recall data to identify systemic problems underlying device recalls. Instead of using RFS - the recall database to improve quality and safety, FDA has primarily used this database for processing and tracking the progress of individual recalls. In the final scathing remark against FDA, GAO identified one of the major gaps in the recall process - ability to ensure that the highest-risk recalls were implemented in an effective and timely manner by the FDA.