5 Most Recall-Prone Medical Devices

May 8, 2014

9 Slides

First there were issues with leaking, low-voltage batteries. Then it was a pressure sensor calibration drift.

The sad thing is that Hospira actually wasn’t alone when it came to its GemStar Infusion System being involved in multiple serious recalls.

Look at the five devices garnering the most Class I recall designations from the FDA since the start of 2012, and two involved infusion systems including GemStar. Another two involved implanted drug infusion pumps.

It is little wonder that the FDA considers infusion pumps to be a high-recall area in need of more attention.

And when multiple types of problems are found with a single device, questions arise whether there were systemic issues behind the way companies were guaranteeing manufacturing quality for device components. It is a growing challenge for many medical device manufacturers as supply networks become increasingly complex and outsourced.

Here’s a rundown of five medical devices drawing the most Class I recall designations since the start of 2012. Read on to find out more.

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