Medical device recalls fell by 21% to 284 in the third quarter of 2018, according to a report by Stericycle Expert Solutions. Machine failure was the top cause of recalls based on units, while software led the way based on numbers of recalls, the report says.
The total number of medtech recalls for Q3 was lower than the last two quarters but higher than the three quarters before that. Recalled units decreased 31% to around 29.4 million — the lowest since Q1 2017.
Machine failure accounted for 48.1% of recalled units for the first time since Q1 2016, mainly due to one large recall. (Endologix recalled 61,300 AFX Endovascular abdominal aortic aneurysm systems due to the risk of Type III endoleaks, according to the FDA. When a Type III endoleak occurs, blood continues to flow into the aneurysm, increasing the likelihood of a rupture and possibly injury or death.) Last quarter, machine failure accounted for just 0.3% of recalled units.
The average recall size was 103,375, down slightly from last quarter’s 117,774 and the lowest since Q1 2017. At 21.8%, software was the top cause based on recalls for the 10th consecutive quarter. Software issues accounted for 62 recalls in Q3, followed by mislabeling issues (43 recalls), quality issues (42) and “outside of specifications” (32).
Slightly more than half of medical device recalls were nationwide, including 14 million Class 1 recalled units. One hundred seventy-one individual companies reported recalls during the quarter — the highest number since Q3 2014.