Serious medical device recalls nearly doubled in Q2

Medical device recalls at the Class I level were up 88% during the second quarter of 2017, and the major culprit was quality issues involving device part malfunctioning, according to a new report from Stericycle ExpertSolutions.

Quality played a significant role among the 15 serious medical device recalls during the second quarter, partly because it encompasses such a host of problems including failure to establish durability, approving products before they were ready, and poor quality of components.

There was also a noticeable uptick versus the previous quarter in pharmaceutical and food recalls that FDA labeled as Class I, according to the Stericycle report.

“Class I is the most critical type of recall, so to see increases across multiple industries where serious adverse consequences or death can occur is certainly concerning,” Michael Good, VP of marketing and sales at Stericycle ExpertSolutions, said in a news release.

Medical device recalls overall were down 3%, to 275 – making this year’s second quarter the lowest quarter for the number of device recalls over the past year. Recalled units, however, were up more than sevenfold in number – a 628% increase to nearly 67.6 million that made the second quarter higher than 15 of the last 18 quarters for the number of recalled units.

The average number of medical device units involved in Class I recalls is 876,076 per quarter so far in 2017, nearly triple the 310,158 average in 2016. The average was 276,233 in 2015.

Here are some of the notable FDA Class I recalls from Q2 2017:

• FDA labels Vascular Solutions Venture catheters recall as Class I

• FDA updates on Getinge/Datascope IABP recall, labels as Class I

• FDA labels Zimmer Biomet SpF spinal fusion stimulator recall as Class I

• Deaths prompt Abbott recall of Thoratec HeartMate II controllers

• Abbott recalls select heart catheters over balloon sheath issues

• FDA labels Philips Respironics V60 ventilator recall as Class I

• FDA labels Medtronic HVAD splice kit recall as Class I

• Medtronic updates on HVAD system controller recall, labeled as Class I

• Medtronic’s StrataMR Recall labeled as Class I

• Merit Medical recalls Prelude sheath introducer over tip separation issues

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Associate editor Fink Densford contributed to this story.

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