FDA warns of Class 1 recalls from Boston Scientific, Dräger and Insulet

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The FDA publicized three previously disclosed recalls from Boston Scientific ($BSX), Dräger and Insulet ($PODD). From time to time, the agency sends out alerts about important recalls over website and via email, adding a sense of urgency to the trio of Class 1 corrective actions, which are reserved for situations in which the use of the faulty devices may cause serious injury or death.

More than 5,600 of Boston Scientific's Chariot guiding sheaths have been recalled due to complaints of the shaft of the device separating, potentially causing small pieces of the device to break off and obstruct blood flow. The recall covers all units of the sheath manufactured between March 17, 2015, and Nov. 10, 2015.

Boston Scientific issued a recall letter in December, and has received 14 complaints of the device separating.

The sheath is used to place interventional and diagnostic devices into a patient's peripheral vasculature (the veins and arteries of the arms, legs, hands or feet).

Perseus A500 anesthesia workstation--Courtesy of Dräger

In addition, the FDA said the Dräger Perseus A500 anesthesia workstations manufactured between June 2013 and September 2015 because a "faulty power switch may fail, causing the workstation to alarm and shut down unexpectedly."

The FDA said an unexpected shutdown of the workstation could cause patients to not receive enough anesthesia or oxygen. Germany's Dräger received one report of the event occurring, resulting in no injuries or deaths.

A total of 34 workstations have been up for recall since November from hospitals in Illinois, Maine, New York, Ohio, Pennsylvania and Wisconsin.

Lastly, the agency notified the public of the recall of 26,230 boxes of Insulet's Omnipod Insulin Management System due to failure or delay of the insertion of the needle. This could interrupt insulin delivery, leading to life-threatening hyperglycemia (high blood sugar).

Insulet notified customers of the issue on Nov. 2, 2015, and received 10 reports of the malfunction occurring, though the event did not result in any serious injuries or deaths.

All recalls are eventually classified in the FDA's recall database, and some are given more attention on the FDA's website. Boston Scientific and Insulet also put out releases explaining their recalls to the public.

- read the FDA release about the Boston Scientific recall | here's the company release
- read the FDA release about the Dräger recall

- read the FDA release about Insulet recall | here's the company release | previous FMD coverage

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