|Insulet's OmniPod--Courtesy of Insulet|
Insulet's ($PODD) bad year continued, as the company revealed a voluntary recall of 18 lots of the wearable OmniPod pump for insulin delivery, including 15 lots distributed in the U.S.
The FDA took the step of posting the company's release on its website, something it does from time to time when it wants to bring certain safety issues to the public's attention.
The release lists the affected lot numbers, saying that 1% to 2% of the Pods in those lots suffer from needle mechanisms that are slow to or fail to deploy, meaning insulin delivery will be delayed or will not commence. The issue has resulted in 66 medical device reports, including three that required medical intervention. But the company said there have been no reports of deaths or serious injuries.
Insulet said that is has corrected the manufacturing process and implemented additional inspection steps.
This is the latest in a string of setbacks for the Billerica, MA company and its flagship product.
In March, the company received a dreaded Form 483 from the FDA following a plant inspection. The company released certain lots of its OmniPod pumps that did not meet the FDA's standards in mid-2013 and the first half of 2014, according to an SEC filing.
And during an August earnings call, the company said the troubled Billerica plant is back on track, but only after it had issued a voluntary recall of more than 400,000 OmniPod pumps in July.
- read the release