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Safety concerns led Philips Respironics to recall millions of respiratory machines. A year later, many are still using them despite the possible risks.

Healthcare

Inspectors repeatedly found manufacturing and device quality problems with the HeartWare heart pump. But the FDA did not penalize the company, and patients had the device implanted on their hearts without knowing the facts.

First published on Medtronic's HeartWare HVAD pump system has been hit with a slew of recalls in recent months and the rate of device malfunction reports documented since it's been on the market in an FDA database outpaces competing products. So far this year, the FDA issued three Class I recalls for the system, including issues with delayed or stalled restarts and updates to instructions for use. However, issues with the system go back to nearly as early as the product received its premarket approval from the FDA in 2012, about four years before Medtronic acquired the product through its $1....